sign in sign up
<<
Home , Cystocele, Rectocele

Federal Register / Vol. 80, No. 39 / Friday, February 27, 2015 / Proposed Rules 10637

Environmental Policy Act of 1969 (b) Definition. authorization. If authorization to enter, (NEPA) (42 U.S.C. 4321–4370f), and (1) The term ‘‘designated transit through, anchor in, or remain in have made a preliminary determination representative’’ means Coast Guard the regulated area is granted by the that this action is one of a category of Patrol Commanders, including Coast Captain of the Port Savannah or a actions that do not individually or Guard coxswains, petty officers, and designated representative, all persons cumulatively have a significant effect on other officers operating Coast Guard and vessels receiving such authorization the human environment. This proposed vessels, and Federal, state, and local must comply with the instructions of rule involves waterway use restrictions officers designated by or assisting the the Captain of the Port Savannah or a that would be otherwise published as a Captain of the Port Savannah in the designated representative. Temporary Final Rule within the enforcement of the regulated area. (5) Coast Guard Marine Safety Unit Savannah Captain of the Port Zone. This (2) Hurricane Port Condition Savannah will attempt to notify the rule is categorically excluded from YANKEE. Set when weather advisories maritime community of periods during further review under paragraph 34(g) of indicate that sustained Gale Force which these safety zones will be in Figure 2–1 of the Commandant winds from a tropical or hurricane force effect via Broadcast Notice to Mariners Instruction. A preliminary storm are predicted to make landfall at or by on-scene designated environmental analysis checklist the port within 24 hours. representatives. supporting this determination and a (3) Hurricane Port Condition ZULU. (6) The Coast Guard will provide Categorical Exclusion Determination are Set when weather advisories indicate notice of the regulated area via available in the docket where indicated that sustained Gale Force winds from a Broadcast Notice to Mariners or by on- under ADDRESSES. We seek any tropical or hurricane force storm are scene designated representatives. comments or information that may lead predicted to make landfall at the port (7) This regulation does not apply to to the discovery of a significant within 12 hours. authorized law enforcement agencies (c) Regulations. environmental impact from this operating within the regulated area. (1) Hurricane Port Condition Dated: February 2, 2015. proposed rule. YANKEE. All commercial, oceangoing A.M. Beach, List of Subjects in 33 CFR Part 165 vessels and barges over 500 gross tons are prohibited from entering the Commander, U.S. Coast Guard, Captain of Harbors, Marine safety, Navigation the Port Savannah. (water), Reporting and recordkeeping regulated areas designated as being in Port Condition YANKEE; within 24 [FR Doc. 2015–04163 Filed 2–26–15; 8:45 am] requirements, Security measures, BILLING CODE 9110–04–P Waterways. hours of anticipated landfall of gale force winds (39mph) from tropical or For the reasons discussed in the hurricane force storm; or upon the Coast preamble, the Coast Guard proposes to Guard setting Port Condition YANKEE DEPARTMENT OF VETERANS amend 33 CFR part 165 as follows: for inbound ocean going commercial AFFAIRS PART 165—REGULATED NAVIGATION vessel traffic over 500 GT. Oceangoing 38 CFR Part 4 AREAS AND LIMITED ACCESS AREAS commercial vessel traffic outbound will be authorized to transit through the RIN 2900–AP13 ■ regulated areas until Port Condition 1. The authority citation for part 165 Schedule for Rating Disabilities; continues to read as follows: ZULU. (2) Hurricane Port Condition ZULU. Gynecological Conditions and Authority: 33 U.S.C. 1231; 46 U.S.C. All commercial, oceangoing vessels and Disorders of the Breast Chapter 701, 3306, 3703; 50 U.S.C. 191, 195; 33 CFR 1.05–1, 6.04–1, 6.04–6, 160.5; Pub. L. barges over 500 gross tons are AGENCY: Department of Veterans Affairs. 107–295, 116 Stat. 2064; Department of prohibited from entering the regulated ACTION: Proposed rule. Homeland Security Delegation No. 0170.1. areas designated as being in Port ■ 2. Add § 165.732 to read as follows: Condition ZULU; within 12 hours of SUMMARY: The Department of Veterans anticipated landfall of a tropical storm Affairs (VA) proposes to amend the § 165.732 Safety Zone; Marine Safety Unit or hurricane; or upon the Coast Guard portion of the VA Schedule for Rating Savannah Safety Zone for Heavy Weather setting Port Condition ZULU, unless Disabilities (VASRD or rating schedule) and other Natural Disasters, Savannah written permission is obtained from the that addresses gynecological conditions Captain of the Port Zone, Savannah, GA. Captain of the Port. All ship-to-shore and disorders of the breast. The purpose (a) Regulated Areas. The following cargo operations must cease six hours of these changes is to incorporate areas are established as safety zones prior to setting Port Condition Zulu. medical advances that have occurred during the specified conditions: (3) Emergency Waterway Restriction since the last review, update current (1) Savannah, GA. All waters within for Other Disasters. Any natural or other medical terminology, and provide clear the Port of Savannah, GA, encompassed disasters that are anticipated to affect evaluation criteria. The proposed rule within following locations: starting at the Captain of the Port Savannah area of reflects advances in medical knowledge, the demarcation line drawn across the responsibility will result in the recommendations from the seaward extremity of the Savannah prohibition of commercial vessel traffic Gynecological Conditions and Disorders River entrance, and encompassing all of transiting or remaining in any of the two of the Breast Work Group (Work Group), the waters of the Savannah River, regulated areas predicted to be affected which is comprised of subject matter Savannah GA. as designated by the Captain of the Port experts from both the Veterans Benefits (2) Brunswick, GA. All waters starting Savannah. Administration (VBA) and the Veterans at the demarcation line drawn across the (4) Persons and vessels desiring to Health Administration (VHA), and seaward extremity of the Savannah enter, transit through, anchor in, or comments from experts and the public River entrance, and encompassing all of remain in the regulated area may gathered as part of a public forum. The the waters of the Brunswick River, contact the Captain of the Port public forum, focusing on revisions to Brunswick GA. Savannah via telephone at (912) 247– the gynecological conditions and (3) All coordinates are North 0073, or a designated representative via disorders of the breast section of the American Datum 1983. VHF radio on channel 16, to request VASRD, was held on January 24, 2012.

VerDate Sep<11>2014 16:15 Feb 26, 2015 Jkt 235001 PO 00000 Frm 00011 Fmt 4702 Sfmt 4702 E:\FR\FM\27FEP1.SGM 27FEP1 tkelley on DSK3SPTVN1PROD with PROPOSALS 10638 Federal Register / Vol. 80, No. 39 / Friday, February 27, 2015 / Proposed Rules

DATES: Comments must be received on Diagnostic Code 7610 ‘‘Vulva, disease women during and after service is or before April 28, 2015. or injury of (including vulvovaginitis)’’ essential. Women who suffer premature loss of function in both ovaries are at ADDRESSES: Current diagnostic code 7610 Written comments may be increased risk for cardiovascular submitted through addresses impairments associated with disease or injury of the vulva. The vulva disease, stroke, lung cancer, cognitive www.Regulations.gov; by mail or hand- impairment or dementia, Parkinsonism, refers to the exterior anatomical portion delivery to Director, Regulation Policy osteoporosis, depressive or anxiety of the female genitalia and includes the and Management (02REG), Department symptoms, and . The . ‘‘Vulva,’’ Mayo Clinic, http:// of Veterans Affairs, 810 Vermont risks appear to be greater for women www.mayoclinic.org/vulva/img- Avenue NW., Room 1068, Washington, who are younger at the time of 20005974 (last visited June 20, 2014). To DC 20420; or by fax to (202) 273–9026. premature loss of ovarian function. provide clarity as to the applicability of Comments should indicate that they are Studies have shown that even women this diagnostic code and to promote submitted in response to ‘‘RIN 2900– who have both ovaries removed ‘‘after consistent and adequate evaluations, VA AP13—Schedule for Rating Disabilities; the onset of natural had an proposes to update the title of this Gynecological Conditions and Disorders increased risk of deleterious outcomes.’’ of the Breast.’’ Copies of comments diagnostic code to specifically include Lynne T. Shuster et al., ‘‘Prophylactic received will be available for public injury or disease of the clitoris, in bilateral oophorectomy jeopardizes inspection in the Office of Regulation addition to the vulva. long-term health,’’ 18(4), American Policy and Management, Room 1068, Diagnostic Code 7615 ‘‘Ovary, disease, Society for Reproductive Medicine, between the hours of 8:00 a.m. and 4:30 injury, or adhesions of’’ Menopausal Medicine S1, S1–S5 (2010). p.m., Monday through Friday (except Currently, a male Veteran is entitled holidays). Please call (202) 461–4902 for Current diagnostic code 7615 to a 30 percent evaluation for service- an appointment. (This is not a toll-free addresses impairments associated with connected removal of one testicle when number.) In addition, during the disease, injury or adhesions of the the second testicle, for reasons comment period, comments may be ovaries. VA proposes to place a note unrelated to service, is absent or ceases viewed online through the Federal under diagnostic code 7615 to identify to function. 38 CFR 4.115b, Diagnostic two common diseases associated with Docket Management System (FDMS) at Code 7524, Note. However, the current ovarian dysfunction resulting in www.Regulations.gov. VASRD does not provide a similar abnormal menstrual cycles: evaluation for a female Veteran whose FOR FURTHER INFORMATION CONTACT: and secondary second ovary is absent or ceases to Ioulia Vvedenskaya, Medical Officer, . Dysmenorrhea is pain function for reasons unrelated to Part 4 VASRD Regulations Staff (211C), associated with menstruation and is the service. With consideration of the Compensation Service, Veterans most commonly reported menstrual studies discussed above demonstrating Benefits Administration, Department of disorder. ‘‘Dysmenorrhea,’’ American the significant health risks from removal Veterans Affairs, 810 Vermont Avenue College of Obstetricians and or loss of function of both ovaries, VA NW., Washington, DC 20420, (202) 461– Gynecologists (July 2012), http:// proposes to add a note to diagnostic ∼ 9700. (This is not a toll-free telephone www.acog.org/ /media/For%20Patients code 7619 in order to equalize VA number.) /faq046.pdf?dmc compensation for female Veterans. =1&ts=20130904T1049007771 (last SUPPLEMENTARY INFORMATION: As part of visited Jan. 21, 2014). Secondary Diagnostic Codes 7621 ‘‘, VA’s ongoing revision of the VA amenorrhea occurs when a woman who ,’’ 7622 ‘‘Uterus, displacement Schedule for Rating Disabilities (VASRD has been having normal menstrual of,’’ and 7623 ‘‘Pregnancy, surgical or rating schedule), VA proposes cycles stops menstruating for 6 or more complications of ’’ changes to 38 CFR 4.116, which pertains months. Tarannum Master-Hunter & Current diagnostic codes 7621 to gynecological conditions and Diana L. Heiman, ‘‘Amenorrhea: through 7623 address impairment disorders of the breast. The proposed Evaluation and Treatment,’’ 73 associated with various degrees of changes will: (1) Update the medical American Family Physician 1374, 1374– female . Uterine terminology of certain gynecological 82 (2006). The proposed note will state prolapse is evaluated under current conditions and disorders of the breast, that for the purpose of disability diagnostic code 7621, as either (1) (2) add medical conditions not currently evaluation, a disease, injury, or complete through the in the rating schedule, and (3) refine adhesions of the ovaries resulting in and introitus at 50 percent, or (2) evaluation criteria based on medical ovarian dysfunction affecting the incomplete uterine prolapse at 30 advances that have occurred since the menstrual cycle, such as dysmenorrhea percent. Uterine displacement is last revision and current understanding and secondary amenorrhea, shall be evaluated under current diagnostic code of functional changes associated with or rated under diagnostic code 7615. 7622, as either (1) marked uterine resulting from disease or injury displacement and frequent or Diagnostic Code 7619 ‘‘Ovary, removal (pathophysiology). continuous menstrual disturbances at 30 of’’ Schedule of Ratings—Gynecological percent, or (2) uterine displacement Conditions and Disorders of the Breast Diagnostic code 7619, ‘‘Ovary, with adhesions and irregular removal of,’’ addresses impairment menstruation at 10 percent. Finally, Section 4.116 currently lists 19 associated with complete and partial surgical complications of pregnancy are diagnostic codes encompassing removal of the ovaries. Service- evaluated under current diagnostic code conditions involving injury or disease of connected complete removal of both 7623, as either (1) with or female reproductive organs and of the ovaries is currently evaluated at 100 at 50 percent, or (2) with breast. VA proposes to revise these percent for the three months following relaxation of at 10 percent. codes, through addition, removal, or removal and then 30 percent thereafter. To update VASRD, VA proposes to other revisions, to reflect current With the continued expansion of consolidate these three diagnostic codes medical science and terminology, and women’s roles in military service, better into one diagnostic code. Specifically, functional impairment. understanding of the health effects on VA proposes to amend diagnostic code

VerDate Sep<11>2014 16:15 Feb 26, 2015 Jkt 235001 PO 00000 Frm 00012 Fmt 4702 Sfmt 4702 E:\FR\FM\27FEP1.SGM 27FEP1 tkelley on DSK3SPTVN1PROD with PROPOSALS Federal Register / Vol. 80, No. 39 / Friday, February 27, 2015 / Proposed Rules 10639

7621 to be titled, ‘‘Pelvic organ prolapse vagina can protrude beyond the vaginal Urogynecologic Society pelvic organ due to injury, disease, or surgical opening (introitus). Pelvic organ prolapse classification system,’’ 175 Am complications of pregnancy.’’ VA prolapse includes anterior vaginal wall J Obstet Gynecol 1467, 1467–70 (1996). proposes this consolidation because all prolapse (cystocele, ), As for the functional impairment of these diagnostic codes represent posterior vaginal wall prolapse associated with each stage of severity, different types of pelvic organ prolapse (, rectocele, perineal VA proposes to assign a 50 percent (displacement) and describe various deficiency) and uterine or vaginal vault evaluation in cases of severe pelvic degrees of their displacement to or prolapse. A woman can present with organ prolapse, where on examination beyond the vaginal walls. Furthermore, prolapse of one or more of these sites. complete or almost complete eversion of as discussed in more detail below, Christopher Maher et al., ‘‘Surgical the total length of the vagina is present, current medicine has a reliable management of pelvic organ prolapse in and the length of the protrusion beyond classification system that provides for women,’’ Cochrane Database of the is within 2 centimeters of the uniform evaluation of functional Systematic Reviews (2010), http:// total vaginal length. VA proposes to impairment due to pelvic organ onlinelibrary.wiley.com/doi/10.1002/ assign a 30 percent evaluation in cases prolapse (displacement), regardless of 14651858.CD004014.pub4/abstract (last of moderate prolapse, where on which pelvic organ is involved. accessed Jan. 21, 2014). A woman’s examination, the most severe portion of Therefore, combining the evaluations symptoms are largely based on the the prolapse is more than 1 centimeter currently found in diagnostic codes severity of her prolapse. Women with below the hymen, but no further than 2 7621 through 7623 would better reflect mild cases of uterine prolapse may have cm less than the total vaginal length. the current understanding of anatomy, no obvious symptoms or require no Finally, VA proposes to assign a 10 physiology, and functional impairment active intervention. However, as the percent evaluation in cases of mild due to disease or injury of pelvic organs. uterus slips further out of normal prolapse, where on examination, the VA also proposes to place a note under position, it can place pressure on other most severe portion of the prolapse is diagnostic code 7621 that will describe pelvic organs (such as the bladder or between 1 cm or less above and 1 cm pelvic organ prolapse and identify bowel) causing a variety of symptoms or more below the hymen. common types of prolapse, including such as a feeling of heaviness or VA also proposes to eliminate uterine or vaginal vault prolapse, pressure in the , , references to frequent or continuous cystocele, urethrocele, rectocele, abdomen or lower back pain, pain menstrual disturbances, adhesions, and enterocele, or any combination. This during intercourse, a protrusion of irregular menstruation as a measure of note would assist field personnel in tissue from the opening of the vagina, the degree of uterine displacement, selecting the appropriate diagnostic recurrent bladder infections, because the symptoms noted are either outdated or adequately contemplated by code for these diagnosed conditions. , difficulty with urination the POP–Q system. For example, uterine Currently, diagnostic codes 7621 and or urinary frequency or urgency. G. displacement, also known as uterine 7622 address uterine prolapse and Willy Davila et al., ‘‘Vaginal Vault prolapse, occurs when uterine displacement, respectively; Suspension’’ (updated Sept. 6, 2013), muscles and stretch and however, uterine displacement is just an Medscape, http:// weaken and the uterus slips down into outdated reference to uterine prolapse. emedicine.medscape.com/article/ or protrudes out of the vagina. Minimal Therefore, separate diagnostic codes are 1848619-overview#aw2aab6b9 (last uterine prolapse generally does not redundant and unnecessary. As for accessed Jan. 21, 2014). Therefore, it is diagnostic code 7623, it provides for require therapy or cause any essential to identify the severity of any evaluation of pelvic organ displacement impairment because the patient usually pelvic organ prolapse in order to such as rectocele, cystocele, and does not have any symptoms. However, determine the level of functional relaxation of perineum when due to uterine descent of the at or impairment. surgical complications of pregnancy. through the vaginal opening (introitus) However, all of these pelvic organ To ensure consistent evaluation of can become symptomatic. Symptoms of displacements can occur independently pelvic organ prolapse, VA proposes to moderate and severe uterine prolapse from surgical complications of base its rating criteria on the pelvic include a sensation of vaginal fullness pregnancy. Therefore, an update to organ prolapse (POP) classification or pressure, back pain, vaginal spotting VASRD is needed to account for these system. POP presents the herniation of from ulceration of the protruding cervix situations. the pelvic organs to or beyond the or vagina, difficulty with sexual This proposed revision is also vaginal opening (at the level of the intercourse, lower abdominal necessary to eliminate disparate hymen) and is described using the discomfort, and voiding and difficulties treatment of pelvic organ displacement findings during . with . Typically, the patient found in the current VASRD. In this ‘‘Pelvic Organ Prolapse,’’ American feels a bulge in the lower vagina or the regard, rectocele or cystocele are rated College of Obstetricians and cervix protruding through the vaginal under current diagnostic code 7623 Gynecologists Practice Bulletin, Vol. opening. , rectoceles, or without regard to the severity of the 110, No. 3 (Sept. 2007). The severity of may cause symptoms displacement (and, in turn, the prolapse is graded using the standard commonly associated with pelvic organ symptoms associated with the Pelvic Organ Prolapse Quantification prolapse and lead to patient complaints displacement), whereas uterine prolapse (POP–Q) classification system. The of difficulty with voiding or bowel and displacement (rated under POP–Q examination is an objective, site- movements, recurrent urinary diagnostic codes 7621 and 7622) are specific system that is used to quantify, infections, and/or ‘‘splinting’’ (manually evaluated based on the degree of describe, and stage pelvic support. The supporting the perineum) to defecate. displacement. POP–Q system has proven interobserver Cespedes RD, Cross CA, McGuire EJ., Pelvic organs, such as the uterus, and intraobserver reliability. A.F. Hall et ‘‘Pelvic Prolapse: Diagnosing and bladder or bowel, may protrude into the al., ‘‘Interobserver and intraobserver Treating Uterine and Vaginal Vault vagina due to weakness in the tissues reliability of the proposed International Prolapse,’’ 1(3) MedGenMed (1999). that normally support them. In the most Continence Society, Society of Menstrual abnormalities may occur in severe cases, part or all of the uterus or Gynecologic Surgeons, and American women with or without pelvic organ

VerDate Sep<11>2014 16:15 Feb 26, 2015 Jkt 235001 PO 00000 Frm 00013 Fmt 4702 Sfmt 4702 E:\FR\FM\27FEP1.SGM 27FEP1 tkelley on DSK3SPTVN1PROD with PROPOSALS 10640 Federal Register / Vol. 80, No. 39 / Friday, February 27, 2015 / Proposed Rules

prolapse, but there is usually no causal lymphedema, or disfigurement, as well reconstructive purposes), and/or under relationship or association. Therefore, as to direct rating specialists to evaluate diagnostic code 7626, if appropriate. the references to menstrual any other residual impairment of Again, no change to the existing disturbances, irregular menstruation function, including gynecological, evaluation criteria (found in current and adhesions as symptoms of uterine under appropriate diagnostic code(s) diagnostic codes 7627 and 7628) is prolapse (displacement) should be within the appropriate body system. proposed. removed, because they do not reflect The surgical management of gynecologic New Diagnostic Code 7632 ‘‘Female current medical science and practice. malignancies and benign diseases has sexual arousal disorder (FSAD)’’ Finally, and as a consequence of this evolved over the last decades. However, proposed consolidation, VA also these sometimes complex procedures VA proposes to add a new diagnostic proposes to delete current diagnostic encompass radical pelvic and upper code 7632, titled ‘‘Female sexual arousal codes 7622 ‘‘Uterus, displacement of’’ abdominal , including associated disorder (FSAD),’’ in order to account and 7623 ‘‘Pregnancy, surgical urologic and intestinal procedures that for impairment due to this condition in complications of’’ as the evaluation may be required to remove the the female Veteran population. FSAD criteria are now contained in the neoplasm. Oliver Zivanovic & Dennis refers to the continual or recurrent proposed diagnostic code 7621. Chi, ‘‘Surgical Resection and inability of a woman to accomplish or Reconstruction for Advanced and maintain an ample lubrication-swelling Diagnostic Codes 7627 ‘‘Malignant reaction during sexual intercourse. This neoplasms of gynecological system or Recurrent Gynecologic Malignancies,’’ 3 Expert Rev. of Obstetrics & Gynecology lack of physical response may be either breast’’ and 7628 ‘‘Benign neoplasms of lifelong or acquired, and either the gynecological system or breast’’ 677, 677–690 (2008). Additionally, VA proposes a minor editorial revision of generalized or situation-specific. FSAD Current diagnostic codes 7627 and replacing the word ‘‘X-ray’’ with the is the second most common sexual 7628 address impairment associated word ‘‘radiation’’ as it pertains to health concern for women, affecting 26 with malignant and benign neoplasms therapeutic procedure to reflect a percent of adult women. Emma Hitt, of the gynecological system and the change in medical terminology. ‘‘Alprostadil Shows Efficacy in Female breast. VA proposes to restructure the Within this reorganization, VA also Sexual Arousal Disorder’’ (May 25, current rating criteria by separating the proposes to add two new diagnostic 2012), Medscape, http:// evaluations for impairments due to codes, 7630 ‘‘Malignant neoplasms of www.medscape.com/viewarticle/764590 gynecological neoplasms from the the breast’’ and 7631 ‘‘Benign (last accessed Jan. 21, 2014). Current evaluations for impairments due to neoplasms of the breast and other statistics show that FSAD affects an breast neoplasms. This proposed injuries of the breast’’ in order to estimated 30 to 45 million women in the separation keeps disability account for impairment due to benign United States alone. Medscape Medical compensation data related to male and malignant breast tumors News, ‘‘Potential Drug Therapy for breast cancer and non-cancerous tumors (neoplasms) as well as other injuries to Female Sexual Dysfunction Presented’’ separate from disability compensation the breast not included elsewhere in the (June 28, 2000), Medscape, http:// data related to gynecological neoplasms VASRD. This addition would allow VA www.medscape.com/viewarticle/411930 and also provides ease of use for to adequately evaluate and track (last accessed Jan. 21, 2014). Clinical disability rating specialists. Men possess disabilities due to benign breast research shows that some aspects of a small amount of nonfunctioning breast neoplasms as well as other injuries, FSAD are likely caused in part by tissue (breast tissue that cannot produce such as blast trauma. VA proposes to decreased blood flow to the genital area. milk) that is concentrated in the area place two notes under diagnostic codes Therefore, poor genital blood flow is directly behind the nipple on the chest 7630 and 7631 to identify common believed to contribute to FSAD similar wall. Like breast cancer in women, chronic residuals associated with to the role of vascular disease in male cancer of the male breast is the injuries of the breast and benign and erectile dysfunction. Medscape Medical uncontrolled growth of the abnormal malignant breast tumors and to instruct News, ‘‘New Approaches to Female cells of this breast tissue. Male breast rating specialists to rate accordingly. Sexual Arousal Disorder’’ (May 31, cancer constitutes about 1 percent of all Breast surgery is the most common 2001), Medscape, http:// cases of breast cancers. ‘‘Male Breast choice of treatment for benign and www.medscape.com/viewarticle/434478 Cancer,’’ National Cancer Institute— malignant tumors of the breast and is an (last accessed Jan. 21, 2014). Although National Institutes of Health (Updated established risk factor for development treatment of sexual dysfunction in men Sept. 19, 2013), http://www.cancer.gov/ of scars, lymphedema, or disfigurement. has been improved by currently cancertopics/pdq/treatment/malebreast/ These chronic post-treatment residuals marketed pharmaceuticals there are no Patient/page1 (last accessed Jan. 21, result in functional impairment such as US Food and Drug Administration 2014). limitation of arm, shoulder, and wrist (FDA) approved treatments for FSAD. Therefore, VA proposes to retitle motion, or loss of grip strength, or loss FDA recently issued draft guidance for diagnostic code 7627 as, ‘‘Malignant of sensation, or residuals from industry regarding clinical development neoplasms of gynecological system’’ and harvesting of muscles for reconstructive of drug products for FSAD. diagnostic code 7628 as, ‘‘Benign purposes. Angelique F. Vitug & Lisa A. Currently, male Veterans with service neoplasms of gynecological system.’’ Newman, ‘‘Complications in Breast connected penile deformity and loss of Additionally, under diagnostic codes Surgery,’’ 87 Surgical Clinics of North erectile power receive a 20 percent 7627 and 7628, VA proposes to clarify America 431, 431–451 (2007). disability evaluation under diagnostic the existing note which instructs rating The proposed notes will therefore code 7522 and are eligible for special specialists to rate chronic residuals instruct rating specialists to rate chronic monthly compensation. In cases where (following surgery or other treatments). residuals according to impairment of there is no penile deformity present, but Specifically, VA proposes to identify function due to scars, lymphedema, or there is service connected loss of those chronic residuals commonly disfigurement (e.g., limitation of arm, erectile power, VA’s policy is to associated with treatment for neoplasms shoulder, and wrist motion, or loss of evaluate male Veterans analogous to of the gynecological system, to include grip strength, or loss of sensation, or diagnostic code 7522, assigning a 0 impairment of function due to scars, residuals from harvesting of muscles for percent rating; Eligibility for special

VerDate Sep<11>2014 17:20 Feb 26, 2015 Jkt 235001 PO 00000 Frm 00014 Fmt 4702 Sfmt 4702 E:\FR\FM\27FEP1.SGM 27FEP1 tkelley on DSK3SPTVN1PROD with PROPOSALS Federal Register / Vol. 80, No. 39 / Friday, February 27, 2015 / Proposed Rules 10641

monthly compensation due to loss of programs or the rights and obligations of Medical Care Benefits; 64.104, Pension use of a creative organ (SMC–K) is also recipients thereof; or (4) Raise novel for Non-Service-Connected Disability considered. See 38 CFR 4.20 and 4.115b, legal or policy issues arising out of legal for Veterans; 64.109, Veterans Diagnostic Code 7522. mandates, the President’s priorities, or Compensation for Service-Connected In order to ensure gender parity, VA the principles set forth in this Executive Disability; and 64.110, Veterans proposes the creation of a new Order.’’ Dependency and Indemnity diagnostic code 7632 ‘‘Female sexual The economic, interagency, Compensation for Service Connected arousal disorder (FSAD).’’ There is no budgetary, legal, and policy Death. diagnostic code in current § 4.116 which implications of this proposed rule have Signing Authority allows for analogous rating of female been examined, and it has been sexual arousal disorder, to include determined not to be a significant The Secretary of Veterans Affairs, or consideration of special monthly regulatory action under Executive Order designee, approved this document and compensation. Under proposed 12866. VA’s impact analysis can be authorized the undersigned to sign and diagnostic code 7632, female Veterans found as a supporting document at submit the document to the Office of the with service connected FSAD but http://www.regulations.gov, usually Federal Register for publication without physical damage to female within 48 hours after the rulemaking electronically as an official document of genitalia would be evaluated at 0 document is published. Additionally, a the Department of Veterans Affairs. Jose percent with a note directing rating copy of this rulemaking and its impact D. Riojas, Chief of Staff, Department of personnel to consider eligibility for analysis are available on VA’s Web site Veterans Affairs, approved this special monthly compensation (SMC– at http://www.va.gov/orpm/, by document on December 1, 2014, for K). following the link for ‘‘VA Regulations publication. Technical Amendments Published From FY 2004 Through Fiscal List of Subjects in 38 CFR Part 4 Year to Date.’’ VA also proposes several technical Disability benefits, Pensions, amendments. We would add a citation Regulatory Flexibility Act Veterans. reference to 38 U.S.C. 1155 at the end The Secretary hereby certifies that Dated: February 20, 2015. of § 4.116, and we would update this proposed rule would not have a William F. Russo, Appendix A, B, and C of part 4 to reflect significant economic impact on a the above noted proposed amendments. Acting Director, Office of Regulation Policy substantial number of small entities as & Management, Office of the General Counsel, Executive Orders 12866 and 13563 they are defined in the Regulatory U.S. Department of Veterans Affairs. Flexibility Act, 5 U.S.C. 601–612. This Executive Orders 12866 and 13563 proposed rule would not affect any For the reasons set out in the direct agencies to assess the costs and small entities. Only certain VA preamble, VA proposes to amend 38 benefits of available regulatory beneficiaries could be directly affected. CFR part 4 as follows: alternatives and, when regulation is Therefore, pursuant to 5 U.S.C. 605(b), necessary, to select regulatory this rulemaking is exempt from the PART 4—SCHEDULE FOR RATING approaches that maximize net benefits initial and final regulatory flexibility DISABILITIES (including potential economic, analysis requirements of sections 603 ■ 1. The authority citation for part 4 environmental, public health and safety and 604. effects, and other advantages; continues to read as follows: distributive impacts; and equity). Unfunded Mandates Authority: 38 U.S.C. 1155, unless Executive Order 13563 (Improving The Unfunded Mandates Reform Act otherwise noted. Regulation and Regulatory Review) of 1995 requires, at 2 U.S.C. 1532, that Subpart B—Disability Ratings emphasizes the importance of agencies prepare an assessment of quantifying both costs and benefits, anticipated costs and benefits before ■ 2. Amend § 4.116 as follows: reducing costs, harmonizing rules, and issuing any rule that may result in the ■ a. Revise the entry for diagnostic code promoting flexibility. Executive Order expenditure by State, local, and tribal 7610; 12866 (Regulatory Planning and governments, in the aggregate, or by the ■ b. Add a note at the end of the entries Review) defines a ‘‘significant private sector, of $100 million or more for diagnostic codes 7615 and 7619; regulatory action,’’ requiring review by (adjusted annually for inflation) in any ■ c. Revise the entry for diagnostic code the Office of Management and Budget one year. This proposed rule would 7621; (OMB), unless OMB waives such have no such effect on State, local, and ■ d. Remove the entries for diagnostic review, as ‘‘any regulatory action that is tribal governments, or on the private codes 7622 and 7623; likely to result in a rule that may: (1) sector. ■ e. Revise the entries for diagnostic Have an annual effect on the economy codes 7627 and 7628; of $100 million or more or adversely Paperwork Reduction Act ■ f. Add entries for diagnostic codes affect in a material way the economy, a This proposed rule contains no 7630 through 7632 in numerical order; sector of the economy, productivity, provisions constituting a collection of and competition, jobs, the environment, information under the Paperwork ■ g. Add an authority citation at the end public health or safety, or State, local, Reduction Act of 1995 (44 U.S.C. 3501– of the section. or tribal governments or communities; 3521). (2) Create a serious inconsistency or The revisions and additions to read as otherwise interfere with an action taken Catalog of Federal Domestic Assistance follows: or planned by another agency; (3) The Catalog of Federal Domestic § 4.116 Schedule of ratings— Materially alter the budgetary impact of Assistance program numbers and titles gynecological conditions and disorders of entitlements, grants, user fees, or loan for this rule are 64.009, Veterans the breast.

VerDate Sep<11>2014 16:15 Feb 26, 2015 Jkt 235001 PO 00000 Frm 00015 Fmt 4702 Sfmt 4702 E:\FR\FM\27FEP1.SGM 27FEP1 tkelley on DSK3SPTVN1PROD with PROPOSALS 10642 Federal Register / Vol. 80, No. 39 / Friday, February 27, 2015 / Proposed Rules

Rating

******* 7610 Vulva or clitoris, disease or injury of (including vulvovaginitis).

******* 7615 * * * Note: For the purpose of VA disability evaluation, a disease, injury, or adhesions of the ovaries resulting in ovarian dys- function affecting the menstrual cycle, such as dysmenorrhea and secondary amenorrhea, shall be rated under diag- nostic code 7615.

******* 7619 * * * Note: In cases of the removal of one ovary as the result of a service-connected injury or disease, with the absence or non- functioning of a second ovary unrelated to service, an evaluation of 30 percent will be assigned for the service-connected ovarian loss.

******* 7621 Pelvic organ prolapse due to injury, disease, or surgical complications of pregnancy. Severe prolapse: Complete or almost complete eversion of the total length of the vagina shown on examination, with the length of the protrusion (or prolapse) extending beyond the hymen within 2 cm of total vaginal length ...... 50 Moderate prolapse: On examination the most severe portion of the prolapse is more than 1 cm below the hymen, but pro- trudes no further than 2 cm less than the total vaginal length ...... 30 Mild prolapse: On examination the most severe portion of the prolapse is between 1 cm or less above the hymen and 1 cm or more below the hymen ...... 10 Note: Pelvic organ prolapse occurs when a pelvic organ such as bladder, urethra, uterus, vagina, small bowel, or rectum drops (prolapse) from its normal place in the abdomen. Conditions associated with pelvic organ prolapse include: Uterine or vaginal vault prolapse, cystocele, urethrocele, rectocele, enterocele, or any combination thereof.

******* 7627 Malignant neoplasms of gynecological system ...... 100 Note: A rating of 100 percent shall continue beyond the cessation of any surgical, radiation, antineoplastic chemotherapy or other therapeutic procedures. Six months after discontinuance of such treatment, the appropriate disability rating shall be determined by mandatory VA examination. Any change in evaluation based upon that or any subsequent examination shall be subject to the provisions of § 3.105(e) of this chapter. Rate chronic residuals to include scars, lymphedema, dis- figurement, and/or other impairment of function under the appropriate diagnostic code(s) within the appropriate body sys- tem. 7628 Benign neoplasms of gynecological system. Rate chronic residuals to include scars, lymphedema, disfigurement, and/or other impairment of function under the appropriate diagnostic code(s) within the appropriate body system.

******* 7630 Malignant neoplasms of the breast ...... 100 Note: A rating of 100 percent shall continue beyond the cessation of any surgical, radiation, antineoplastic chemotherapy or other therapeutic procedure. Six months after discontinuance of such treatment, the appropriate disability rating shall be determined by mandatory VA examination. Any change in evaluation based upon that or any subsequent examination shall be subject to the provisions of § 3.105(e) of this chapter. Rate chronic residuals according to impairment of function due to scars, lymphedema, or disfigurement (e.g., limitation of arm, shoulder, and wrist motion, or loss of grip strength, or loss of sensation, or residuals from harvesting of muscles for reconstructive purposes), and/or under diagnostic code 7626. 7631 Benign neoplasms of the breast and other injuries of the breast. Rate chronic residuals according to impairment of func- tion due to scars, lymphedema, or disfigurement (e.g., limitation of arm, shoulder, and wrist motion, or loss of grip strength, or loss of sensation, or residuals from harvesting of muscles for reconstructive purposes), and/or under diagnostic code 7626. 7632 Female sexual arousal disorder (FSAD) ...... 1 0 1 Review for entitlement to special monthly compensation under § 3.350 of this chapter.

(Authority: 38 U.S.C. 1155) ■ a. At Sec. 4.116, revise the entries for The revisions and additions to read as diagnostic codes 7610, 7615, 7619, follows: ■ 3. Amend Appendix A to Part 4 as 7621, 7622, 7623, 7627, and 7628; and follows: ■ b. At Sec. 4.116, add entries for Appendix A to Part 4—Table of diagnostic codes 7630 through 7632 in Amendments and Effective Dates Since numerical order. 1946

Diagnostic Sec. code No.

******* 4.116.

******* 7610 Criterion May 22, 1995; title [effective date of final rule].

VerDate Sep<11>2014 16:15 Feb 26, 2015 Jkt 235001 PO 00000 Frm 00016 Fmt 4702 Sfmt 4702 E:\FR\FM\27FEP1.SGM 27FEP1 tkelley on DSK3SPTVN1PROD with PROPOSALS Federal Register / Vol. 80, No. 39 / Friday, February 27, 2015 / Proposed Rules 10643

Diagnostic Sec. code No.

******* 7615 Criterion May 22, 1995; note [effective date of final rule].

******* 7619 Criterion May 22, 1995; note [effective date of final rule].

******* 7621 Criterion May 22, 1995; evaluation [effective date of final rule]. 7622 Removed [effective date of final rule]. 7623 Removed [effective date of final rule].

******* 7627 Criterion March 10, 1976; criterion May 22, 1995; title, note [effective date of final rule]. 7628 Added May 22, 1995; title, criterion [effective date of final rule].

******* 7630 Added [effective date of final rule]. 7631 Added [effective date of final rule]. 7632 Added [effective date of final rule].

*******

■ 4. Amend Appendix B to Part 4 as ■ b. Add entries for diagnostic codes Appendix B to Part 4—Numerical Index follows: 7630 through 7632 in numerical order. of Disabilities ■ a. Revise the entries for diagnostic The revisions and additions to read as codes 7610, 7621, 7627, and 7628; and follows:

Diagnostic code No.

*******

Gynecological Conditions and Disorders of the Breast

7610 ...... Vulva or clitoris, disease or injury of (including vulvovaginitis).

******* 7621 ...... Pelvic organ prolapse due to injury or disease or surgical complications of pregnancy.

******* 7627 ...... Malignant neoplasms of gynecological system. 7628 ...... Benign neoplasms of gynecological system.

******* 7630 ...... Malignant neoplasms of the breast. 7631 ...... Benign neoplasms of the breast and other injuries of the breast. 7632 ...... Female sexual arousal disorder (FSAD).

*******

■ 5. Amend Appendix C to Part 4 as ■ d. Under the heading ‘‘Neoplasms: ■ g. Add in alphabetical order the follows: Benign:’’ remove ‘‘Gynecological or heading ‘‘Pelvic organ prolapse due to ■ a. Add in alphabetical order the breast’’ and in its place add the entry injury or disease or surgical heading ‘‘Female sexual arousal ‘‘Gynecological’’. complications of pregnancy, including disorder (FSAD)’’ and its diagnostic ■ e. Under the heading ‘‘Neoplasms: uterine or vaginal vault prolapse, code ‘‘7632’’. Malignant:’’ add in alphabetical order cystocele, urethrocele, rectocele, ■ b. Under the heading ‘‘Injury’’ add in new entry ‘‘Breast’’ and its diagnostic enterocele, or combination’’ and its alphabetical order new entry ‘‘Breast’’ code ‘‘7630’’. diagnostic code ‘‘7621’’. and its diagnostic code ‘‘7631’’. ■ ■ f. Under the heading ‘‘Neoplasms: h. Remove the heading ‘‘Pregnancy, ■ c. Under the heading ‘‘Neoplasms: Malignant:’’ remove ‘‘Gynecological or surgical complications’’ and its Benign:’’ add in alphabetical order an breast’’ and in its place add the entry diagnostic code ‘‘7623’’. entry ‘‘Breast’’ and its diagnostic code ‘‘Gynecological’’. ‘‘7631’’.

VerDate Sep<11>2014 16:15 Feb 26, 2015 Jkt 235001 PO 00000 Frm 00017 Fmt 4702 Sfmt 4702 E:\FR\FM\27FEP1.SGM 27FEP1 tkelley on DSK3SPTVN1PROD with PROPOSALS 10644 Federal Register / Vol. 80, No. 39 / Friday, February 27, 2015 / Proposed Rules

■ i. Under the heading ‘‘Uterus’’ remove ■ j. Remove the heading ‘‘Vulva disease The additions and revisions to read as the entry ‘‘Displacement’’ and its or injury of’’ and add in its place ‘‘Vulva follows: diagnostic code ‘‘7622’’. or clitoris, disease or injury of’’. Appendix C to Part 4—Alphabetical Index of Disabilities

Diagnostic code No.

******* Female sexual arousal disorder (FSAD) ...... 7632

******* Injury:

******* Breast ...... 7631

******* Neoplasms: Benign: Breast ...... 7631

******* Gynecological ...... 7628

******* Malignant: Breast ...... 7630

******* Gynecological ...... 7627

******* Pelvic organ prolapse due to injury or disease or surgical complications of pregnancy, including uterine or vaginal vault prolapse, cystocele, urethrocele, rectocele, enterocele, or combination ...... 7621

******* Vulva or clitoris, disease or injury of ...... 7610

*******

[FR Doc. 2015–03851 Filed 2–26–15; 8:45 am] (NAAQS). The infrastructure Maintenance Section, Air Programs BILLING CODE 8320–01–P requirements are designed to ensure that Branch (AR–18J), U.S. Environmental the structural components of each Protection Agency, 77 West Jackson state’s air quality management program Boulevard, Chicago, Illinois 60604. ENVIRONMENTAL PROTECTION are adequate to meet the state’s Such deliveries are only accepted AGENCY responsibilities under the CAA. during the Regional Office normal hours DATES: Comments must be received on of operation, and special arrangements 40 CFR Part 52 or before March 30, 2015. should be made for deliveries of boxed [EPA–R05–OAR–2012–0991; EPA–R05– ADDRESSES: Submit your comments, information. The Regional Office official OAR–2013–0435; FRL–9923–43–Region 5] identified by Docket ID No. EPA–R05– hours of business are Monday through Friday, 8:30 a.m. to 4:30 p.m., excluding OAR–2012–0991 (2010 NO2 Approval and Promulgation of Air infrastructure SIP elements) and Docket Federal holidays. Quality Implementation Plans; Indiana; ID No. EPA–R05–OAR–2013–0435 Instructions: Direct your comments to Infrastructure SIP Requirements for (2010 SO2 infrastructure SIP elements) Docket ID. EPA–R05–OAR–2012–0991 the 2010 NO2 and SO2 NAAQS by one of the following methods: and EPA–R05–OAR–2013–0435. EPA’s AGENCY: Environmental Protection 1. www.regulations.gov: Follow the policy is that all comments received Agency. on-line instructions for submitting will be included in the public docket without change and may be made ACTION: Proposed rule. comments. 2. Email: [email protected]. available online at www.regulations.gov, SUMMARY: The Environmental Protection 3. Fax: (312) 408–2279. including any personal information Agency (EPA) is proposing to approve 4. Mail: Douglas Aburano, Chief, provided, unless the comment includes elements of state implementation plan Attainment Planning and Maintenance information claimed to be Confidential (SIP) submissions from Indiana Section, Air Programs Branch (AR–18J), Business Information (CBI) or other regarding the infrastructure U.S. Environmental Protection Agency, information whose disclosure is requirements of section 110 of the Clean 77 West Jackson Boulevard, Chicago, restricted by statute. Do not submit Air Act (CAA) for the 2010 nitrogen Illinois 60604. information that you consider to be CBI dioxide (NO2) and sulfur dioxide (SO2) 5. Hand Delivery: Douglas Aburano, or otherwise protected through National Ambient Air Quality Standards Chief, Attainment Planning and www.regulations.gov or email. The

VerDate Sep<11>2014 16:15 Feb 26, 2015 Jkt 235001 PO 00000 Frm 00018 Fmt 4702 Sfmt 4702 E:\FR\FM\27FEP1.SGM 27FEP1 tkelley on DSK3SPTVN1PROD with PROPOSALS