Federal Register / Vol. 78, No. 184 / Monday, September 23, 2013 / Notices 58311

OMB Comment DEPARTMENT OF HEALTH AND on both abstinence and contraception to HUMAN SERVICES prevent pregnancy and sexually OMB is required to make a decision transmitted infections (STIs); and at concerning the collection of information Administration for Children and least three adulthood preparation between 30 and 60 days after Families subjects. The Personal Responsibility publication of this document in the Education grant program funding is Federal Register. Therefore, a comment Submission for OMB Review; available for fiscal years 2010 through is best assured of having its full effect Comment Request 2014. Pursuant to monitoring these state if OMB receives it within 30 days of Title: State Personal Responsibility programs, grantees submit a semiannual publication. Written comments and Education Program (PREP). report on their performance. recommendations for the proposed OMB No.: 0970–0380. A request is being made to solicit information collection should be sent Description: The Patient Protection comments from the public on directly to the following: Office of and Affordable Care Act, 2010, also paperwork reduction as it relates to Management and Budget, Paperwork known as health care reform, amended ACYF’s receipt of the following Reduction Project, Fax: 202–395–7285, Title V of the Social Security Act (42 document from applicants and Email: OIRA_SUBMISSION@ U.S.C. 701 et seq.) as amended by awardees: sections 2951 and 2952(c), by adding OMB.EOP.GOV. Attn: Desk Officer for Performance Progress Report the Administration for Children and section 513, authorizing the Personal Families. Responsibility Education Program Respondents: 50 States and 9 (PREP). The President signed into law Territories, to include, District of Robert Sargis, the Patient Protection and Affordable Columbia, Puerto Rico, Virgin Islands, Reports Clearance Officer. Care Act on March 23, 2010, Public Law Guam, American Samoa, Northern [FR Doc. 2013–22996 Filed 9–20–13; 8:45 am] 111–148, which added the new PREP Mariana Islands, the Federated States of formula grant program. The purpose of Micronesia, the Marshall Islands and BILLING CODE 4184–01–P this program is to educate adolescents Palau

ANNUAL BURDEN ESTIMATES

Average Number of Number of burden Total Instrument respondents responses per hours per burden hours respondent response

Performance Progress Reports ...... 59 2 16 1,888

Estimated Total Annual Burden the Administration for Children and diseases, including endpoint Hours: 1,888. Families. development and selection, use of surrogate endpoints and the accelerated Robert Sargis, Additional Information approval pathway, clinical trial design, Reports Clearance Officer. conduct and analysis, safety Copies of the proposed collection may [FR Doc. 2013–22995 Filed 9–20–13; 8:45 am] be obtained by writing to the considerations, and dose selection; and BILLING CODE 4184–01–P Administration for Children and to discuss ways to encourage and accelerate the development of new Families, Office of Planning, Research therapies for pediatric rare diseases. and Evaluation, 370 L’Enfant DEPARTMENT OF HEALTH AND FDA is seeking input on these topics Promenade SW., Washington, DC 20447, HUMAN SERVICES from academic, clinical, and treating Attn: ACF Reports Clearance Officer. All Food and Drug Administration communities; patients and advocacy requests should be identified by the title groups; industry; and governmental of the information collection. Email [Docket No. FDA–2013–N–0985] agencies. Input from this public address: [email protected]. workshop will help develop a strategic Complex Issues in Developing Drug OMB Comment plan to encourage and accelerate the and Biological Products for Rare development of new therapies for rare OMB is required to make a decision Diseases; Public Workshop; Request diseases. for Comments concerning the collection of information Date and Time: The public workshop between 30 and 60 days after AGENCY: Food and Drug Administration, will be held on January 6, 2014, from 8 publication of this document in the HHS. a.m. to 5 p.m. and on January 7, 2014, Federal Register. Therefore, a comment ACTION: Notice of public workshop; from 8 a.m. to 4:45 p.m. is best assured of having its full effect request for comments. Location: The public workshop will if OMB receives it within 30 days of be held at FDA’s White Oak Campus, publication. Written comments and The Food and Drug Administration 10903 New Hampshire Ave., Building recommendations for the proposed (FDA) is announcing the following 31 Conference Center, the Great Room information collection should be sent public workshop entitled ‘‘Complex (Rm. 1503), Silver Spring, MD 20993– directly to the following: Office of Issues in Developing Drug and 0002. Entrance for the public meeting Management and Budget, Paperwork Biological Products for Rare Diseases.’’ participants (non-FDA employees) is Reduction Project, Fax: 202–395–7285, The purpose of the public workshop is through Building 1 where routine Email: OIRA_SUBMISSION@ twofold: To discuss complex issues in security check procedures will be OMB.EOP.GOV. Attn: Desk Officer for clinical trials for developing drug and performed. For parking and security biological products (‘‘drugs’’) for rare information, please refer to http://

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www.fda.gov/AboutFDA/ complex issues in clinical trials for certain aspects of drug development for WorkingatFDA/BuildingsandFacilities/ developing drugs for rare diseases and rare diseases are challenging, and U.S. WhiteOakCampusInformation/ to discuss ways to encourage and regulations allow for flexibility and ucm241740.htm. accelerate the development of new scientific judgment in applying Contact Person: Tomeka Arnett, therapies for pediatric rare diseases. In approval standards and in determining Center for Drug Evaluation and order to permit the widest possible the kind and quantity of data required Research, Food and Drug opportunity to obtain public comment, for a particular drug to meet the Administration, 10903 New Hampshire FDA is soliciting either electronic or statutory standards. Ave., Bldg. 51, Rm. 6331, Silver Spring, written comments on all aspects of the This public workshop is being held in MD 20993–0002, 301–796–2500, FAX: public workshop. The deadline for response to section 510—Pediatric rare 301–847–3529, email: Tomeka.Arnett@ submitting comments regarding this diseases of the Food and Drug fda.hhs.gov. public workshop is March 10, 2014. Administration Safety and Innovation Registration: Registration is free and Regardless of attendance at the public Act (Pub. L. 122–144) (125 Stat. 1050), available on a first-come, first-served workshop, interested persons may whereby FDA is required to hold at least basis. Persons interested in attending submit either electronic comments one public meeting to discuss ways to the public workshop must register regarding this document to http:// encourage and accelerate the online by December 20, 2013. Early www.regulations.gov or written development of new therapies for registration is recommended because comments to the Division of Dockets pediatric rare diseases. Additionally, as facilities are limited and, therefore, FDA Management (HFA–305), Food and Drug stated in section IX.E—Enhancing may limit the number of participants Administration, 5630 Fishers Lane, Rm. Regulatory Science and Expediting Drug from each organization. If time and 1061, Rockville, MD 20852. It is only Development, Advancing Development space permits, onsite registration on the necessary to send one set of comments. of Drugs for Rare Diseases of the day of the public workshop will be Identify comments with the docket Prescription Drug User Fee Act provided beginning at 7:30 a.m. Seating number found in brackets in the Reauthorization Performance Goals and will be available on a first-come, first- heading of this document. In addition, Procedures Fiscal Years 2013 through served basis. when responding to specific topics as 2017 (available at http://www.fda.gov/ If you need special accommodations outlined in section II, please identify the downloads/forindustry/userfees/ due to a disability, please contact topic you are addressing. Received prescriptiondruguserfee/ Tomeka Arnett (see Contact Person) no comments may be seen in the Division ucm270412.pdf ), FDA will conduct a later than 7 days in advance. of Dockets Management between 9 a.m. public meeting to discuss complex To register for the public workshop, issues in clinical trials for studying please visit FDA’s Drugs News & and 4 p.m., Monday through Friday, and will be posted to the docket at http:// drugs for rare diseases. Events—Meetings, Conferences & This public workshop is being held in Workshops calendar at http:// www.regulations.gov. Transcripts: Please be advised that as conjunction with FDA’s Center for www.fda.gov/Drugs/NewsEvents/ Devices and Radiological Health and ucm132703.htm. (Select this public soon as a transcript is available, it will be accessible at http:// Office of Orphan Products Development workshop from the posted events list.) public workshop entitled ‘‘Complex Please provide complete contact www.regulations.gov. A transcript will also be available in either hardcopy or Issues in Developing Medical Devices information for each attendee, including for Pediatric Patients Affected by Rare on CD–ROM, after submission of a name, title, affiliation, address, email, Diseases,’’ which will be held on Freedom of Information request. Written and telephone number. Those without January 8, 2014, from 8 a.m. to 5 p.m., requests are to be sent to the Division Internet access should contact Tomeka announced in a separate notice of Freedom of Information (ELEM– Arnett to register (see Contact Person). publishing elsewhere in this issue of the 1029), Food and Drug Administration, Registrants will receive confirmation Federal Register. after they have been accepted. You will 12420 Parklawn Dr., Rockville, MD be notified if you are on a waiting list. 20857. II. Topics for Discussion at the Public Streaming Webcast of the Public SUPPLEMENTARY INFORMATION: Workshop Workshop: This public workshop will FDA is announcing a public I. Background also be Webcast. Persons interested in workshop regarding complex issues in viewing the Webcast may visit FDA’s The Act of 1983 (the clinical trials for developing drugs for Drugs News & Events—Meetings, Orphan Drug Act) (Pub. L. 97–414), as rare diseases and to discuss ways to Conferences & Workshops calendar at amended, defines a ‘‘ or encourage and accelerate the http://www.fda.gov/Drugs/NewsEvents/ condition’’ to include those that affect development of new therapies for ucm132703.htm. (Select this public less than 200,000 persons in the United pediatric rare diseases. The purpose of workshop from the posted events list.) States. This definition is codified in this public workshop is to seek broad Select https://collaboration.fda.gov/ section 526(a)(2) of the Federal Food, input from rare disease experts and drugbiord/ to view the Webcast. If you Drug, and Cosmetic Act (21 U.S.C. stakeholders, including industry; have never attended a Connect Pro 360bb(a)(2)). The Orphan Drug Act academic and clinical experts; patients event before, test your connection at provides incentives to reduce the cost and advocates and governmental https://collaboration.fda.gov/common/ and increase the potential reward for agencies to address complex issues in help/en/support/meeting_test.htm. developing products for small numbers rare disease product development. (FDA has verified the Web site of patients; however, it does not alter Topics for discussion on day 1 addresses in this document, but FDA is the statutory standards for marketing include: (1) Complex issues for not responsible for any subsequent approval. To gain approval, all drugs endpoints, including endpoint changes to the Web sites after this must demonstrate substantial evidence selection, use of surrogate endpoints document publishes in the Federal of effectiveness, safety, and product and the accelerated approval pathway, Register.) quality for the treatment of the clinical significance of primary Comments: FDA is holding this public condition in the identified patient endpoints, and development of patient- workshop to obtain information about population. FDA acknowledges that reported outcome instruments; (2)

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complex issues for trial design conduct ADDRESSES: The meeting will be held at perspectives on the adequacy of the and analysis; (3) development of the FDA White Oak Campus, 10903 available therapies. These meetings will translational and regulatory science to New Hampshire Ave., Building 31 include participation of FDA review support rare disease drug development; Conference Center, in Section A of the divisions, the relevant patient and (4) safety and dosing Great Room (Rm. 1503), Silver Spring, community, and other interested considerations, including safety MD 20993. Entrance for the public stakeholders. exposures and assessment of dose meeting participants is through Building On April 11, 2013, FDA published a selection. 1, where routine security check notice (78 FR 08441) in the Federal Topics for discussion on day 2 procedures will be performed. For more Register announcing the disease areas include: (1) Collaborative research information on parking and security for meetings in fiscal years (FY) 2013– networks for pediatric rare diseases; (2) procedures, please refer to http:// 2015, the first 3 years of the 5-year safety considerations for pediatric rare www.fda.gov/AboutFDA/ PDUFA V timeframe. To develop the list diseases; (3) pediatric rare cancers; and WorkingatFDA/BuildingsandFacilities/ of disease areas, the Agency used (4) development of gene therapies for WhiteOakCampusInformation/ several criteria that were outlined in the rare pediatric disorders. Discussions ucm241740.htm. April 11 notice. The Agency obtained will help develop a report that includes Submit electronic comments to public comment on these criteria and a strategic plan to encourage and www.regulations.gov. Submit written potential disease areas through a notice accelerate the development of new comments to the Division of Dockets for public comment published in the therapies for pediatric rare diseases. Management (HFA–305), Food and Drug Federal Register on September 24, 2012 FDA encourages individuals, patients, Administration, 5630 Fishers Lane, Rm. (77 FR 23454, and through a public advocates, industry, consumer groups, 1061, Rockville, MD 20852. All meeting held on October 25, 2012. In health care professionals, researchers comments should be identified with the selecting the disease areas, FDA and other interested persons to attend docket number found in brackets in the carefully considered the public this public workshop. heading of this document. comments received and the perspectives Dated: September 17, 2013. FDA will post the agenda of its review divisions. By the end of FY approximately 5 days before the meeting 2015, FDA will initiate another public Leslie Kux, at: http://www.fda.gov/ForIndustry/ process for determining the disease Assistant Commissioner for Policy. UserFees/PrescriptionDrugUserFee/ areas for FY 2016–2017. More [FR Doc. 2013–22959 Filed 9–20–13; 8:45 am] ucm363203.htm. information, including the list of disease BILLING CODE 4160–01–P FOR FURTHER INFORMATION CONTACT: areas and a general schedule of Graham Thompson, Center for Drug meetings, is posted on FDA’s Web site at http://www.fda.gov/ForIndustry/ DEPARTMENT OF HEALTH AND Evaluation and Research, Food and UserFees/PrescriptionDrugUserFee/ HUMAN SERVICES Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 1199, ucm326192.htm. Food and Drug Administration Silver Spring, MD 20993, 301–796– II. Public Meeting Information 5003, FAX: 301–847–8443, email: [Docket No. FDA–2013–N–1041] [email protected]. A. Purpose and Scope of the Meeting Fibromyalgia Public Meeting on SUPPLEMENTARY INFORMATION: As part of Patient-Focused Drug Patient-Focused Drug Development Development, FDA will obtain patient I. Background on Patient-Focused Drug and patient stakeholder input on AGENCY: Food and Drug Administration, Development symptoms of fibromyalgia that matter HHS. FDA has selected fibromyalgia as the most to patients and on current ACTION: Notice of public meeting; focus of a meeting under Patient- approaches to treating fibromyalgia. request for comments. Focused Drug Development, an Fibromyalgia is a chronic disorder initiative that involves obtaining a better characterized by widespread SUMMARY: The Food and Drug understanding of patients’ perspectives musculoskeletal pain and tenderness in Administration (FDA) is announcing a on the severity of the disease and the multiple tender points and may be public meeting and an opportunity for available therapies for the condition. accompanied by fatigue, sleep public comment on Patient-Focused Patient-Focused Drug Development is disturbances, irritable bowel syndrome, Drug Development for fibromyalgia. being conducted to fulfill FDA’s headache, and mood disorders. While Patient-Focused Drug Development is performance commitments made as part there is currently no definitive cure, part of FDA’s performance of the authorization of PDUFA V under treatments for fibromyalgia include commitments in the fifth authorization Title I of the Food and Drug Safety and medications and lifestyle changes with of the Prescription Drug User Fee Act Innovation Act (FDASIA) (Pub. L. 112– emphasis on minimizing symptoms and (PDUFA V). The public meeting is 144). The full set of performance improving general health and daily intended to allow FDA to obtain commitments is available on the FDA function. FDA is interested in obtaining patients’ perspectives on the impact of Web site at http://www.fda.gov/ a better understanding of fibromyalgia fibromyalgia on daily life as well as the downloads/forindustry/userfees/ patients’ perspectives on the severity of available therapies for fibromyalgia. prescriptiondruguserfee/ the disease and the available therapies DATES: The public meeting will be held ucm270412.pdf. used to treat fibromyalgia and its on December 10, 2013, from 1 p.m. to FDA has committed to obtain the symptoms. 5 p.m. Registration to attend the meeting patient perspective in twenty disease The questions that will be asked of must be received by November 27, 2013. areas during the course of PDUFA V. patients and patient stakeholders at the See the SUPPLEMENTARY INFORMATION For each disease area, the Agency will meeting are listed in this section, section for information on how to conduct a public meeting to discuss the organized by topic. For each topic, a register for the meeting. Submit disease and its impact on patients’ daily brief patient panel discussion will begin electronic or written comments by lives, the types of treatment benefit that the dialogue, followed by a facilitated February 10, 2013. matter most to patients, and patients’ discussion inviting comments from

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