Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Draft Guidance for Industry and Food and Drug Administration Staff; “Class II Special Controls Guidance Document: Labeling for Natural Rubber Latex Condoms Classified Under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”, 66645-66646 [E8-26828]
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Federal Register / Vol. 73, No. 218 / Monday, November 10, 2008 / Notices
Item No.
1 ...........
Bureau
Subject
WIRELINE COMPETITION.
TITLE: High-cost Universal Service Support (WC Docket No. 05–337); Federal-State Joint Board on Universal Service (CC Docket No. 96–45); Lifeline and Link Up (WC Docket No. 03–109); Universal Service Contribution Methodology (WC Docket No. 06–122); Telecommunications Relay Services and
Speech-to-Speech Services for Individuals with Hearing and Speech Disabilities (CG Docket No. 03–
123); Implementation of the Local Competition Provisions in the Telecommunications Act of 1996 (CC
Docket No. 96–98); Developing a Unified Intercarrier Compensation Regime (CC Docket No. 01–92);
Intercarrier Compensation for ISP-Bound Traffic (CC Docket No. 99–68); and IP-Enabled Services
(WC Docket No. 04–36).
SUMMARY: The Commission will consider a Report and Order, Order on Remand, and Further Notice of
Proposed Rulemaking addressing the comprehensive reform of intercarrier compensation and universal service.
Federal Communications Commission.
Marlene H. Dortch,
Secretary.
[FR Doc. E8–26740 Filed 11–6–08; 11:15 am]
BILLING CODE 6712–01–P
FEDERAL RESERVE SYSTEM
jlentini on PROD1PC65 with NOTICES
Formations of, Acquisitions by, and
Mergers of Bank Holding Companies
The companies listed in this notice
have applied to the Board for approval,
pursuant to the Bank Holding Company
Act of 1956 (12 U.S.C. 1841 et seq.)
(BHC Act), Regulation Y (12 CFR Part
225), and all other applicable statutes
and regulations to become a bank
holding company and/or to acquire the
assets or the ownership of, control of, or
the power to vote shares of a bank or
bank holding company and all of the
banks and nonbanking companies
owned by the bank holding company,
including the companies listed below.
The applications listed below, as well
as other related filings required by the
Board, are available for immediate
inspection at the Federal Reserve Bank
indicated. The applications also will be
available for inspection at the offices of
the Board of Governors. Interested
persons may express their views in
writing on the standards enumerated in
the BHC Act (12 U.S.C. 1842(c)). If the
proposal also involves the acquisition of
a nonbanking company, the review also
includes whether the acquisition of the
nonbanking company complies with the
standards in section 4 of the BHC Act
(12 U.S.C. 1843). Unless otherwise
noted, nonbanking activities will be
conducted throughout the United States.
Additional information on all bank
holding companies may be obtained
from the National Information Center
website at www.ffiec.gov/nic/.
Unless otherwise noted, comments
regarding each of these applications
must be received at the Reserve Bank
indicated or the offices of the Board of
Governors not later than December 5,
2008.
VerDate Aug<31>2005
16:09 Nov 07, 2008
66645
Jkt 217001
A. Federal Reserve Bank of
Richmond (A. Linwood Gill, III, Vice
President) 701 East Byrd Street,
Richmond, Virginia 23261–4528:
1. CapitalSource Inc., CapitalSource
Finance LLC, and CapitalSource TRS
Inc., all of Chevy Chase, Maryland, to
become bank holding companies by
acquiring 100 percent of the voting
shares of CapitalSource Bank, Los
Angeles, California.
Board of Governors of the Federal Reserve
System, November 5, 2008.
Robert deV. Frierson,
Deputy Secretary of the Board.
[FR Doc. E8–26690 Filed 11–7–08; 8:45 am]
BILLING CODE 6210–01–S
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,
PO 00000
Frm 00056
Fmt 4703
Sfmt 4703
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.
E:\FR\FM\10NON1.SGM
10NON1
66646
Federal Register / Vol. 73, No. 218 / Monday, November 10, 2008 / Notices
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 BURDEN1
No. of
Respondents
Annual Frequency
per Response
Total Annual
Responses
Hours per
Response
Total Hours
352
34
1,190
12
14,280
33
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.
manufacturers for year one.
Manufacturers for years two and three.
2 Current
jlentini on PROD1PC65 with NOTICES
3 New
The reporting burden hours to
respondents in the first year is a onetime 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
VerDate Aug<31>2005
16:09 Nov 07, 2008
Jkt 217001
approved under OMB control no. 0910–
0485.
The collection of information under
§ 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
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2008–E–0093]
Determination of Regulatory Review
Period for Purposes of Patent
Extension; IXEMPRA
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) has determined
the regulatory review period for
IXEMPRA and is publishing this notice
of that determination as required by
law. FDA has made the determination
PO 00000
Frm 00057
Fmt 4703
Sfmt 4703
because of the submission of an
application to the Director of Patents
and Trademarks, Department of
Commerce, for the extension of a patent
which claims that human drug product.
ADDRESSES: Submit written comments
and petitions to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852. Submit
electronic comments to https://
www.regulations.gov.
FOR FURTHER INFORMATION CONTACT:
Beverly Friedman, Office of Regulatory
Policy, Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 51,
rm. 6222, Silver Spring, MD 20993–
0002, 301–796–3602.
SUPPLEMENTARY INFORMATION: The Drug
Price Competition and Patent Term
Restoration Act of 1984 (Public Law 98–
417) and the Generic Animal Drug and
Patent Term Restoration Act (Public
Law 100–670) generally provide that a
patent may be extended for a period of
up to 5 years so long as the patented
item (human drug product, animal drug
product, medical device, food additive,
or color additive) was subject to
regulatory review by FDA before the
item was marketed. Under these acts, a
product’s regulatory review period
forms the basis for determining the
amount of extension an applicant may
receive.
A regulatory review period consists of
two periods of time: A testing phase and
E:\FR\FM\10NON1.SGM
10NON1
]]>Agencies
[Federal Register Volume 73, Number 218 (Monday, November 10, 2008)]
[Notices]
[Pages 66645-66646]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-26828]
=======================================================================
-----------------------------------------------------------------------
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
