[Federal Register Volume 73, Number 218 (Monday, November 10, 2008)]
[Notices]
[Pages 66645-66646]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-26828]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2004-D-0375] (formerly Docket No. 2004D-0555)
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Draft Guidance for
Industry and Food and Drug Administration Staff; ``Class II Special
Controls Guidance Document: Labeling for Natural Rubber Latex Condoms
Classified Under 21 CFR 884.5300''
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is announcing that a
proposed collection of information has been submitted to the Office of
Management and Budget (OMB) for review and clearance under the
Paperwork Reduction Act of 1995 (the PRA).
DATES: Fax written comments on the collection of information by
December 10, 2008.
ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be faxed to the Office
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer,
FAX: 202-395-6974, or e-mailed to [email protected]. All
comments should be identified with the OMB control number 0910-NEW and
title ``Class II Special Controls Guidance Document: Labeling for
Natural Rubber Latex Condoms Classified Under 21 CFR 884.5300.'' Also
include the FDA docket number found in brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT: Denver Presley, Jr., Office of
Information Management (HFA-710), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857, 301-827-3793.
SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.
Class II Special Controls Guidance Document: Labeling for Natural
Rubber Latex Condoms Classified Under 21 CFR 884.5300--(OMB Control
Number 0910-NEW)
Under the Medical Device Amendments of 1976 (Public Law 94-295),
class II devices were defined as those devices for which there was
insufficient information to show that general controls themselves would
provide a reasonable assurance of safety and effectiveness, but for
which there was sufficient information to establish performance
standards to provide such assurance.
Condoms without spermicidal lubricant containing nonoxynol-9 are
classified in class II. They were originally classified before the
enactment of provisions of the Safe Medical Devices Act of 1990 (Public
Law 101-629) that broadened the definition of class II devices and now
permit FDA to establish special controls beyond performance standards,
including guidance documents, to help provide reasonable assurance of
the safety and effectiveness of such devices.
[[Page 66646]]
In December 2000, Congress enacted Public Law 106-554, which among
other provisions, directed FDA to ``reexamine existing condom labels''
and ``determine whether the labels are medically accurate regarding the
overall effectiveness or lack of effectiveness in preventing sexually
transmitted diseases* * *.'' FDA is recommending labeling changes
intended to provide important information for condom users, including
the extent of protection provided by condoms against various types of
sexually transmitted diseases.
Respondents to this collection of information are manufacturers and
repackagers of male condoms made of natural rubber latex without
spermicidal lubricant. FDA believes that this is a one-time burden,
because once a label is redesigned, it can be used indefinitely.
In the Federal Register of November 14, 2005 (70 FR 69156), FDA
published a 60-day notice soliciting public comment on the information
collection provisions, contained in the draft special controls guidance
document then entitled ``Labeling for Male Condoms Made of Natural
Rubber Latex.'' FDA has subsequently retitled the special controls
guidance document containing these information collection provisions to
avoid confusion between the guidance established as a special control
for condoms classified under 21 CFR 884.5300 by the final rule
published elsewhere in this issue of the Federal Register and the
November 2005 draft guidance, which remains available (but not for
implementation) in conjunction with the pending proposal to amend
another classification. No comments were received on the information
collection provisions in response to the 60-day notice.
FDA estimates the burden of this collection as follows:
Table 1.--Estimated Annual Reporting Burden\1\
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Annual Frequency Total Annual Hours per
No. of Respondents per Response Responses Response Total Hours
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35\2\ 34 1,190 12 14,280
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3\3\ 34 102 12 1,224
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Total 15,504
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
\2\ Current manufacturers for year one.
\3\ New Manufacturers for years two and three.
The reporting burden hours to respondents in the first year is a
one-time burden of 14,280 hours. FDA expects three new manufacturers or
repackagers to enter the market yearly, and collectively have a one-
time burden of 1,224 hours. The number of respondents and prospective
new manufacturers cited in table 1 of this document are based on FDA's
database of premarket submissions. The remaining figures were derived
from a study performed for FDA by Eastern Research Group, Inc., an
economic consulting firm, to estimate the impact of the 1999 over-the-
counter (OTC) human drug labeling requirements final rule (64 FR 13254,
March 17, 1999). Because the packaging requirements for condoms are
similar to those of many OTC drugs, we believe the burden to redesign
the labeling for OTC drugs is an appropriate proxy for the estimated
burden to redesign condom labeling. Cost estimates were adjusted to
account for inflation using the producer price index.
The draft guidance also refers to previously approved collections
of information found in FDA regulations. The collections of information
under 21 CFR part 807 subpart E have been approved under OMB control
no. 0910-0120; the collections of information under 21 CFR part 820
have been approved under OMB control no. 0910-0073; and the collections
of information in part 801 (21 CFR part 801) have been approved under
OMB control no. 0910-0485.
The collection of information under Sec. 801.437 does not
constitute a ``collection of information'' under the PRA. Rather, it is
a ``public disclosure of information originally supplied by the Federal
Government to the recipient for the purpose of disclosure to the
public'' (5 CFR 1320.3(c)(2)).
Dated: October 30, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-26828 Filed 11-7-08; 8:45 am]
BILLING CODE 4160-01-S