Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Guidance for Industry: Cooperative Manufacturing Arrangements for Licensed Biologics, 59633 [E8-23907]
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Federal Register / Vol. 73, No. 197 / Thursday, October 9, 2008 / Notices
Estimated Total Annual Burden
Hours: 841.50.
In compliance with the requirements
of section 506(c)(2)(A) of the Paperwork
Reduction Act of 1995, the
Administration for Children and
Families is soliciting public comment
on the specific aspects of the
information collection described above.
Copies of the proposed collection of
information can be obtained and
comments may be forwarded by writing
to the Administration for Children and
Families, Office of Administration,
Office of Information Services, 370
L’Enfant Promenade, SW., Washington,
DC 20447, Attn: ACF Reports Clearance
Officer. E-mail address:
infocollection@acf.hhs.gov. All requests
should be identified by the title of the
information collection.
The Department specifically requests
comments on: (a) Whether the proposed
collection of information is necessary
for the proper performance of the
functions of the agency, including
whether the information shall have
practical utility; (b) the accuracy of the
agency’s estimate of the burden of the
proposed collection of information; (c)
the quality, utility, and clarity of the
information to be collected; and (d)
ways to minimize the burden of the
collection of information on
respondents, including through the use
of automated collection techniques or
other forms of information technology.
Consideration will be given to
comments and suggestions submitted
within 60 days of this publication.
Dated: October 3, 2008.
Janean Chambers,
Reports Clearance Officer.
[FR Doc. E8–23884 Filed 10–8–08; 8:45 am]
Manufacturing Arrangements for
Licensed Biologics’’ has been approved
by the Office of Management and
Budget (OMB) under the Paperwork
Reduction Act of 1995.
FOR FURTHER INFORMATION CONTACT:
Jonna Capezzuto, Office of Information
Management (HFA–710), Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301–796–3794.
SUPPLEMENTARY INFORMATION: In the
Federal Register of November 19, 2007
(72 FR 65034), the agency announced
that the proposed information collection
had been submitted to OMB for review
and clearance under 44 U.S.C. 3507. An
agency may not conduct or sponsor, and
a person is not required to respond to,
a collection of information unless it
displays a currently valid OMB control
number. OMB has now approved the
information collection and has assigned
OMB control number 0910–0629. The
approval expires on September 30,
2011. A copy of the supporting
statement for this information collection
is available on the Internet at https://
www.reginfo.gov/public/do/PRAMain.
Dated: September 29, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and
Planning.
[FR Doc. E8–23907 Filed 10–8–08; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2008–N–0314]
BILLING CODE 4184–01–P
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Recall Regulations
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
AGENCY:
ACTION:
Food and Drug Administration
[Docket No. FDA–1999–D–0128] (formerly
Docket No. 1999D–2013)
Agency Information Collection
Activities; Announcement of Office of
Management and Budget Approval;
Guidance for Industry: Cooperative
Manufacturing Arrangements for
Licensed Biologics
AGENCY:
Food and Drug Administration,
sroberts on PROD1PC70 with NOTICES
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing
that a collection of information entitled
‘‘Guidance for Industry: Cooperative
VerDate Aug<31>2005
21:01 Oct 08, 2008
Jkt 217001
Food and Drug Administration,
HHS.
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.
DATES: Fax written comments on the
collection of information by November
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
PO 00000
Frm 00038
Fmt 4703
Sfmt 4703
59633
baguilar@omb.eop.gov. All comments
should be identified with the OMB
control number 0910–0249. Also
include the FDA docket number found
in brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT:
Elizabeth Berbakos, Office of
Information Management (HFA–710),
Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857,
301–796–3792.
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.
FDA Recall Regulations—21 CFR Part
7—(OMB Control Number 0910–0249—
Extension)
Section 701 of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 371) and
part 7, subpart C (21 CFR part 7, subpart
C), set forth the recall regulations
(guidelines) and provide guidance to
manufacturers on recall responsibilities.
The guidelines apply to all FDA
regulated products (i.e., food, including
animal feed; drugs, including animal
drugs; medical devices, including in
vitro diagnostic products; cosmetics;
and biological products intended for
human use). These responsibilities
include: (1) developing a recall strategy
that requires time by the firm to
determine the actions or procedures
required to manage the recall (§ 7.42);
(2) providing FDA with complete details
of the recall including reason(s) for the
removal or correction, risk evaluation,
quantity produced, distribution
information, firm’s recall strategy, a
copy of any recall communication(s),
and a contact official (§ 7.46); (3)
notifying direct accounts of the recall,
providing guidance regarding further
distribution, giving instructions as to
what to do with the product, providing
recipients with a ready means of
reporting to the recalling firm (§ 7.49);
(4) submitting periodic status reports so
that FDA may assess the progress of the
recall (status report information may be
determined by, among other things,
evaluation return reply cards,
effectiveness checks, and product
returns) (§ 7.53); and (5) providing the
opportunity for a firm to request in
writing that FDA terminate the recall
(§ 7.55).
A search of the FDA database was
performed to determine the number of
recalls that took place during fiscal year
2007. The resulting number of recalls
from this database search (2,166) is used
in estimating the current annual
reporting burden for this report. FDA
E:\FR\FM\09OCN1.SGM
09OCN1
]]>Agencies
[Federal Register Volume 73, Number 197 (Thursday, October 9, 2008)]
[Notices]
[Page 59633]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-23907]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-1999-D-0128] (formerly Docket No. 1999D-2013)
Agency Information Collection Activities; Announcement of Office
of Management and Budget Approval; Guidance for Industry: Cooperative
Manufacturing Arrangements for Licensed Biologics
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing that a
collection of information entitled ``Guidance for Industry: Cooperative
Manufacturing Arrangements for Licensed Biologics'' has been approved
by the Office of Management and Budget (OMB) under the Paperwork
Reduction Act of 1995.
FOR FURTHER INFORMATION CONTACT: Jonna Capezzuto, Office of Information
Management (HFA-710), Food and Drug Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301-796-3794.
SUPPLEMENTARY INFORMATION: In the Federal Register of November 19, 2007
(72 FR 65034), the agency announced that the proposed information
collection had been submitted to OMB for review and clearance under 44
U.S.C. 3507. An agency may not conduct or sponsor, and a person is not
required to respond to, a collection of information unless it displays
a currently valid OMB control number. OMB has now approved the
information collection and has assigned OMB control number 0910-0629.
The approval expires on September 30, 2011. A copy of the supporting
statement for this information collection is available on the Internet
at https://www.reginfo.gov/public/do/PRAMain.
Dated: September 29, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-23907 Filed 10-8-08; 8:45 am]
BILLING CODE 4160-01-S
