
[Federal Register: November 10, 2008 (Volume 73, Number 218)]
[Notices]               
[Page 66645-66646]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr10no08-60]                         

=======================================================================
-----------------------------------------------------------------------

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of Management and Budget Review; Comment Request; Draft Guidance for 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.

-----------------------------------------------------------------------

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 oira_submission@omb.eop.gov. 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\
----------------------------------------------------------------------------------------------------------------
                                       Annual Frequency     Total Annual        Hours per
         No. of  Respondents             per Response        Responses           Response         Total Hours
----------------------------------------------------------------------------------------------------------------
35\2\                                                34              1,190                 12             14,280
----------------------------------------------------------------------------------------------------------------
3\3\                                                 34                102                 12              1,224
----------------------------------------------------------------------------------------------------------------
Total                                                                                                     15,504
----------------------------------------------------------------------------------------------------------------
\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
