[Federal Register Volume 61, Number 245 (Thursday, December 19, 1996)]
[Proposed Rules]
[Pages 66953-66954]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-32273]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 351
[Docket No. 80N-0280]
RIN 0910-AA01
Vaginal Contraceptive Drug Products for Over-the-Counter Human
Use; Reopening of the Administrative Record
AGENCY: Food and Drug Administration, HHS.
ACTION: Reopening of the administrative record.
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SUMMARY: The Food and Drug Administration (FDA) is announcing the
reopening of the administrative record for the proposed rulemaking for
over-the-counter (OTC) vaginal contraceptive drug products to allow for
comment on matters considered at the November 22, 1996, joint meeting
of the Nonprescription Drugs, Reproductive Health Drugs, Anti-Infective
Drugs, and Antiviral Drugs Advisory Committees. That meeting is part of
the ongoing review of OTC drug products conducted by FDA.
DATES: Submit comments regarding matters discussed at the November 22,
1996, advisory committee by March 3, 1997. The administrative record
will remain open until March 3, 1997.
ADDRESSES: Submit written comments to the Dockets Management Branch
(HFA-305), Food and Drug Administration, 12420 Parklawn Dr., rm. 1-23,
Rockville, MD 20857.
FOR FURTHER INFORMATION CONTACT: Gloria Chang, Center for Drug
Evaluation and Research (HFD-560), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857, 301-827-2245.
SUPPLEMENTARY INFORMATION: In the Federal Register of December 12, 1980
(45 FR 82014), FDA published an advance notice of proposed rulemaking
to establish a monograph for OTC vaginal contraceptive drug products,
together with the recommendations of the Advisory Review Panel on OTC
Contraceptives and Other Vaginal Drug Products (the Panel). The Panel
recommended that the spermicidal ingredients nonoxynol 9 and octoxynol
9 be considered generally recognized as safe and effective (45 FR 82014
at 82028 to 82030 and 82047). The Panel also recommended final
formulation in vitro testing as an adequate method to determine
effectiveness (45 FR 82014 at 82047).
In the Federal Register of February 3, 1995 (60 FR 6892), the
agency published a proposed rule for OTC vaginal contraceptive drug
products. This proposal would require manufacturers to obtain approved
applications for marketing of OTC vaginal contraceptive drug products.
The agency stated that although nonoxynol 9 and octoxynol 9 kill sperm
in vitro and in vivo, the spermicidal activity and resulting
effectiveness of these contraceptive ingredients cannot be considered
separately from a product's vehicle. Thus, clinical studies are
necessary to establish the effectiveness of the spermicide's final
formulation when used in humans. The agency also announced the
availability of a guidance document that is intended to help
manufacturers of vaginal contraceptive drug products develop data in
support of applications (60 FR 6892 at 6893). The administrative record
for this proposed rule closed on April 3, 1996.
In response to the proposed rule, 13 professional associations, 1
health professional, 1 trade association, 10 public health groups, 4
manufacturers, 1 consumer, and 1 research laboratory submitted
comments. The majority of the comments objected to the agency's
proposal to require approved applications for marketing of OTC vaginal
contraceptive drug products. Copies of the comments received are on
public display in the Dockets Management Branch (address above).
On September 24, 1996, FDA met with the Nonprescription Drug
[[Page 66954]]
Manufacturers Association (NDMA) (Ref. 1) to provide industry an
opportunity to discuss its position on FDA's proposed rule for OTC
vaginal contraceptive drug products. NDMA opposed the requirement of
applications for these products and requested that FDA reconsider its
position to reject monograph standards for OTC vaginal spermicides.
In the Federal Register of October 30, 1996 (61 FR 55990), FDA
announced a joint meeting of the Nonprescription Drugs, Reproductive
Health Drugs, Anti-Infective Drugs, and Antiviral Drugs Advisory
Committees. The meeting took place on November 20-22, 1996, at the
Holiday Inn-Gaithersburg, Two Montgomery Village Ave., Gaithersburg,
MD. On November 22, 1996, the committees discussed proposals and
guidance for clinical efficacy studies on marketed OTC vaginal
spermicides. Issues for discussion included the type of data and
quality of both in vitro and in vivo data needed to support and ensure
spermicidal efficacy in final formulation.
Because the issues have a direct impact on FDA's rulemaking on OTC
vaginal contraceptive drug products, the agency is reopening the
administrative record to specifically allow for comments on the matters
discussed at the November 22, 1996, meeting. Transcripts of the
November 22, 1996, meeting may be requested (by mail or fax) from the
Freedom of Information Staff (HFI-35), 5600 Fishers Lane, rm. 12A-16,
Rockville, MD 20857, 301-443-6310; or FAX 301-443-1726. Requests should
specify date of meeting, name of committee, and a description of
document(s) requested. The agency requests data and information
regarding clinical efficacy studies, and in vivo and in vitro data
needed to support and ensure spermicidal efficacy in final formulation.
Any individual or group may, on or before March 3, 1997, submit to the
Dockets Management Branch (address above), comments and data
specifically limited and relevant to the matters discussed at the
November 22, 1996, meeting. Two copies of any comments are to be
submitted, except that individuals may submit one copy. All comments
are to be identified with the docket number found in brackets in the
heading of this document. The administrative record will remain open
until March 3, 1997.
Reference
(1) Minutes of meeting between FDA and NDMA, September 24, 1996,
coded MM1, Docket No. 80N-0280, Dockets Management Branch.
Dated: December 3, 1996.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 96-32273 Filed 12-18-96; 8:45 am]
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