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2010-09-23
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Sunscreen Drug Products for Over-the-Counter Human Use; Final Monograph; Extension of Effective Date; Reopening of Administrative Record
Rules and Regulations
D09002ee1bdfa9935
D09002ee1bdfa99e5
United States
Department of Health and Human Services
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org
United States Government Agency or Subagency
United States
Food and Drug Administration
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org
United States Government Agency or Subagency
The Food and Drug Administration (FDA) is extending to December 31, 2002, the effective date for the final monograph for over- the-counter (OTC) sunscreen drug products that published in the Federal Register of May 21, 1999 (64 FR 27666). The final monograph established conditions under which OTC sunscreen drug products are generally recognized as safe and effective and not misbranded. The extension of the effective date applies to all OTC sunscreen drug products that would be regulated under parts 310, 352, and 700 (21 CFR parts 310, 352, and 700). In addition, FDA is reopening the administrative record for the rulemaking for OTC sunscreen drug products to allow for comment specifically on the information requested in this document. FDA is taking this action in response to a citizen petition requesting that the agency, among other things, initiate an administrative process to publish a ``comprehensive'' sunscreen final monograph that addresses formulation, labeling, and testing requirements for both ultraviolet B (UVB) and ultraviolet A (UVA) radiation protection.
65 FR 36319
https://www.govinfo.gov/app/details/FR-2000-06-08/00-14212
00-14212
fr08jn00-3
RIN 0910-AA01
4160-01-F
Docket No. 78N-0038
https://www.govinfo.gov/app/details/FR-2000-06-08/00-14212
https://www.govinfo.gov/content/pkg/FR-2000-06-08/html/00-14212.htm
https://www.govinfo.gov/content/pkg/FR-2000-06-08/pdf/00-14212.pdf
Administrative Practice and Procedures
Drugs
Labeling
Medical Devices
Reporting and Recordkeeping Requirements
6 p.
36319
36324
65 FR 36319
Code of Federal Regulations
Title 21 Part 310
21 CFR Part 310
Code of Federal Regulations
Title 21 Part 352
21 CFR Part 352
Code of Federal Regulations
Title 21 Part 700
21 CFR Part 700
Regulation Identification Number 0910-AA01
RIN 0910-AA01
Sunscreen Drug Products for Over-the-Counter Human Use; Final Monograph; Extension of Effective Date; Reopening of Administrative Record; Federal Register Vol. 65, Issue
RULE
00-14212
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
1999-05-21
Docket No. 78N-0038
4160-01-F
00-14212
Final rule; extension of effective date; reopening of administrative record.
The Food and Drug Administration (FDA) is extending to December 31, 2002, the effective date for the final monograph for over- the-counter (OTC) sunscreen drug products that published in the Federal Register of May 21, 1999 (64 FR 27666). The final monograph established conditions under which OTC sunscreen drug products are generally recognized as safe and effective and not misbranded. The extension of the effective date applies to all OTC sunscreen drug products that would be regulated under parts 310, 352, and 700 (21 CFR parts 310, 352, and 700). In addition, FDA is reopening the administrative record for the rulemaking for OTC sunscreen drug products to allow for comment specifically on the information requested in this document. FDA is taking this action in response to a citizen petition requesting that the agency, among other things, initiate an administrative process to publish a ``comprehensive'' sunscreen final monograph that addresses formulation, labeling, and testing requirements for both ultraviolet B (UVB) and ultraviolet A (UVA) radiation protection.
Effective date: The effective date of the amendments to parts 310, 352, and 700 in the regulation published at 64 FR 27666, May 21, 1999, is delayed until December 31, 2002. The amendment in this final rule to Sec. 310.545 is effective December 31, 2002.
Donald Dobbs, Center for Drug Evaluation and Research (HFD-560), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-2222.
Administrative Practice and Procedures
Drugs
Labeling
Medical Devices
Reporting and Recordkeeping Requirements
Human drugs:
Sunscreen products (OTC); final monograph,
http://www.fda.gov/cder/guidance/index.htm
Federal Register
Vol. 65, no. 111
Office of the Federal Register, National Archives and Records Administration
2000-06-08
continuing
daily
deposited
born digital
298 p.
Table of Contents:
AE 2.7:
GS 4.107:
AE 2.106:
KF70.A2
https://www.govinfo.gov/app/details/FR-2000-06-08
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https://www.govinfo.gov/app/details/FR-2000-06-08
https://www.govinfo.gov/content/pkg/FR-2000-06-08/pdf/FR-2000-06-08.pdf
https://www.govinfo.gov/content/pkg/FR-2000-06-08/xml/FR-2000-06-08.xml
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