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PDMA Regulations 67720 Federal Register / Vol. 64, No. 232 / Friday, December 3, 1999 / Rules and Regulations ranging from 3 to 8 years on which the contrary to the public interest. We have List of Subjects in 20 CFR Part 404 various body system listings would no determined that, under 5 U.S.C. Administrative practice and longer be effective unless extended by 553(b)(B), good cause exists for procedure, Blind, Disability benefits, the Secretary of Health and Human dispensing with the notice and public Old-Age, Survivors and Disability Services or revised and promulgated comment procedures in this case. Good Insurance, Reporting and recordkeeping again. Effective March 31, 1995, the cause exists because this regulation only requirements, Social Security. authority to issue regulations was extends the date on which these body transferred to the Commissioner of system listings will no longer be Dated: November 24, 1999. Social Security by section 102 of Public effective. It makes no substantive Kenneth S. Apfel, Law 103±296, the Social Security changes to those listings. The current Commissioner of Social Security. Independence and Program regulations expressly provide that For the reasons set forth in the Improvements Act of 1994. listings may be extended, as well as preamble, part 404, subpart P, chapter In this final rule, we are extending the revised and promulgated again. III of title 20 of the Code of Federal dates on which several body system Therefore, opportunity for prior Regulations is amended as set forth listings will no longer be effective to comment is unnecessary, and we are below. July 2, 2001. These body systems are: issuing this regulation as a final rule. PART 404ÐFEDERAL OLD-AGE, Cardiovascular System (4.00 and In addition, we find good cause for SURVIVORS AND DISABILITY 104.00). dispensing with the 30-day delay in the INSURANCE (1950- ) Digestive System (5.00 and 105.00). effective date of a substantive rule Genito-Urinary System (6.00 and provided by 5 U.S.C. 553(d). As Subpart PÐ[Amended] 106.00). explained above, we are not making any We last extended the dates on which substantive changes in these body 1. The authority citation for subpart P these body system listings would no system listings. However, without an of part 404 continues to read as follows: longer be effective in final rules extension of the expiration dates for Authority: Secs. 202, 205(a), (b), and (d)± published as follows: these listings, we will lack regulatory (h), 216(i), 221(a) and (i), 222(c), 223, 225, June 5, 1997 (62 FR 30746): Digestive guidelines for assessing impairments in and 702(a)(5) of the Social Security Act (42 System and Genito-Urinary System. these body systems at the third step of U.S.C. 402, 405(a), (b), and (d)±(h), 416(i), the sequential evaluation process after 421(a) and (i), 422(c), 423, 425, and January 30, 1998 (63 FR 4570): 902(a)(5)); sec. 211(b), Pub. L. 104±193, 110 Cardiovascular System. the current expiration dates of these listings. In order to ensure that we Stat. 2105, 2189. We believe that the requirements in continue to have regulatory criteria for 2. Appendix 1 to subpart P of part 404 these listings are still valid for our assessing impairments under these is amended by revising items 5, 6, and program purposes. Specifically, if we listings, we find that it is in the public 7 of the introductory text before Part A find that an individual has an interest to make this rule effective upon to read as follows: impairment that meets or is medically publication. equivalent in severity to an impairment Appendix 1 to Subpart PÐListing of in the Listings or functionally Executive Order 12866 Impairments equivalent to the Listings in SSI claims We have consulted with the Office of * * * * * based on disability filed by individuals Management and Budget (OMB) and 5. Cardiovascular System (4.00 and 104.00): under age 18 and also meets the July 2, 2001. determined that this final rule does not statutory duration requirement, we will 6. Digestive System (5.00 and 105.00): July 2, meet the criteria for a significant find that the individual is disabled at 2001. regulatory action under Executive Order the third step of the sequential 7. Genito-Urinary System (6.00 and 106.00): 12866. Thus, it was not subject to OMB July 2, 2001. evaluation process. We are extending review. We have also determined that these dates because we do not expect to * * * * * this final rule meets the plain language develop revised listings criteria for these [FR Doc. 99±31322 Filed 12±2±99; 8:45 am] requirement of Executive Order 12866 body systems by the expiration dates BILLING CODE 4191±02±P and the President's memorandum of currently shown in the regulations. June 1, 1998 (63 FR 31885). However, we are reviewing the listings and we plan to publish proposed and Regulatory Flexibility Act DEPARTMENT OF HEALTH AND final rules over the course of the next HUMAN SERVICES We certify that this final regulation two years. will not have a significant economic Food and Drug Administration Regulatory Procedures impact on a substantial number of small entities. Therefore, a regulatory 21 CFR Parts 203 and 205 Justification for Final Rule flexibility analysis as provided in the [Docket Nos. 92N±0297 and 88N±0258] Pursuant to section 702(a)(5) of the Regulatory Flexibility Act, as amended, Social Security Act, 42 U.S.C. 902(a)(5), is not required. RIN 0910±AA08 as amended by section 102 of Public Law 103±296, SSA follows the Paperwork Reduction Act Prescription Drug Marketing Act of 1987; Prescription Drug Amendments Administrative Procedure Act (APA) This final regulation imposes no of 1992; Policies, Requirements, and rulemaking procedures specified in 5 reporting/recordkeeping requirements Administrative Procedures U.S.C. 553 in the development of its necessitating clearance by OMB. regulations. The APA provides (Catalog of Federal Domestic Assistance AGENCY: Food and Drug Administration, exceptions to its notice and public Program Nos. 96.001, Social Security- HHS. comment procedures when an agency Disability Insurance; 96.002, Social Security- ACTION: Final rule. finds there is good cause for dispensing Retirement Insurance; 96.004, Social with such procedures on the basis that Security-Survivors Insurance; 96.006, SUMMARY: The Food and Drug they are impracticable, unnecessary, or Supplemental Security Income) Administration (FDA) is issuing a final VerDate 29-OCT-99 19:12 Dec 02, 1999 Jkt 190000 PO 00000 Frm 00028 Fmt 4700 Sfmt 4700 E:\FR\FM\03DER1.XXX pfrm08 PsN: 03DER1 Federal Register / Vol. 64, No. 232 / Friday, December 3, 1999 / Rules and Regulations 67721 rule to set forth procedures and PDMA, as modified by the PDA, 1994 proposal called for the submission requirements implementing the amended sections 301, 303, 503, and of comments by May 30, 1994. At the Prescription Drug Marketing Act of 1987 801 of the Federal Food, Drug, and request of certain individuals, the (PDMA), as modified by the Prescription Cosmetic Act (the act) (21 U.S.C. 331, comment period was extended, by Drug Amendments of 1992 (PDA) and 333, 353, 381) to establish restrictions notice in the Federal Register of July 15, the FDA Modernization Act of 1997 (the and requirements relating to various 1994 (59 FR 36107), to August 15, 1994. Modernization Act). The final rule sets aspects of human prescription drug After careful consideration of the forth requirements for the reimportation marketing and distribution. Among comments, the agency has revised and and wholesale distribution of other things, PDMA: (1) Banned the finalized the March 1994 proposal. A prescription drugs; the sale, purchase, sale, purchase, or trade of (or offer to discussion of significant issues, the or trade of, or the offer to sell, purchase, sell, purchase, or trade) drug samples comments received on the proposal, and or trade, prescription drugs that were and drug coupons; (2) restricted the agency's responses to the comments purchased by hospitals or health care reimportation of prescription drugs to follows. entities, or donated to charitable the manufacturer of the drug product or II. Significant Issues and Revisions to organizations; and the distribution of for emergency medical care; (3) the Proposal prescription drug samples. FDA is also established requirements for drug amending certain sections of the sample distribution and the storage and A. Reimportation of Drugs Composed regulations entitled ``Guidelines for handling of drug samples; (4) required Wholly or Partly of Insulin wholesale distributors of prescription State Licensing of Wholesale On November 21, 1997, the Prescription Drug Distributors'' to make drugs to be State licensed and required FDA to establish minimum Modernization Act (Public Law 105± them consistent with this final 115) was enacted. Section 125(a)(2)(D) regulation. requirements for State licensing schemes; (5) established requirements of the Modernization Act amended DATES: Submit written comments on the section 801(d)(1) of the act to prohibit collection of information provisions by for wholesale distribution of prescription drugs by unauthorized the reimportation of a drug composed February 1, 2000. This regulation is wholly or partly of insulin, except by effective December 4, 2000. distributors; (6) prohibited, with certain exceptions, the sale, purchase, or trade the manufacturer of the drug or for ADDRESSES: Submit written comments emergency care. In accordance with the on the collection of information to the (or offer to sell, purchase, or trade) of prescription drugs that were purchased revised statutory requirement, the Dockets Management Branch (HFA± agency has revised proposed §§ 203.10 305), Food and Drug Administration, by hospitals or health care entities, or donated or supplied at a reduced price and 203.12 (21 CFR 203.10 and 203.12) 5630 Fishers Lane, rm.
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