Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Electronic Records; Electronic Signatures, 45722 [05-15544]
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45722
Federal Register / Vol. 70, No. 151 / Monday, August 8, 2005 / Notices
above, and must be received on or
before Friday, August 12, 2005.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Donald S. Clark,
Secretary.
[FR Doc. 05–15683 Filed 8–5–05; 8:45 am]
Food and Drug Administration
BILLING CODE 6750–01–P
Agency Information Collection
Activities; Announcement of Office of
Management and Budget Approval;
Premarket Notification for a New
Dietary Ingredient
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[Docket No. 2005N–0031]
AGENCY:
ACTION:
[Docket No. 2005N–0045]
Agency Information Collection
Activities; Announcement of Office of
Management and Budget Approval;
Electronic Records; Electronic
Signatures
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing
that a collection of information entitled
‘‘Electronic Records; Electronic
Signatures’’ has been approved by the
Office of Management and Budget
(OMB) under the Paperwork Reduction
Act of 1995.
FOR FURTHER INFORMATION CONTACT:
Karen Nelson, Office of Management
Programs (HFA–250), Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857,301–827–1482.
In the
Federal Register of May 11, 2005 (70 FR
24818), 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 0910–0303. The
approval expires on July 31, 2008. A
copy of the supporting statement for this
information collection is available on
the Internet at https://www.fda.gov/
ohrms/dockets.
SUPPLEMENTARY INFORMATION:
Dated: July 27, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05–15544 Filed 8–5–05; 8:45 am]
BILLING CODE 4160–01–S
VerDate jul<14>2003
20:13 Aug 05, 2005
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing
that a collection of information entitled
‘‘Premarket Notification for a New
Dietary Ingredient’’ has been approved
by the Office of Management and
Budget (OMB) under the Paperwork
Reduction Act of 1995.
FOR FURTHER INFORMATION CONTACT:
Peggy Robbins, Office of Management
Programs (HFA–250), Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301–827–1223.
SUPPLEMENTARY INFORMATION: In the
Federal Register of May 3, 2005 (70 FR
22886), 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 0910–0330. The
approval expires on July 31, 2008. A
copy of the supporting statement for this
information collection is available on
the Internet at https://www.fda.gov/
ohrms/dockets.
Dated: July 27, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05–15545 Filed 8–5–05; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2005D–0288]
International Conference on
Harmonisation; Draft Guidance on Q9
Quality Risk Management; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Jkt 205001
Food and Drug Administration,
HHS.
Food and Drug Administration
PO 00000
Notice.
Frm 00081
Fmt 4703
Sfmt 4703
SUMMARY: The Food and Drug
Administration (FDA) is announcing the
availability of a draft guidance entitled
‘‘Q9 Quality Risk Management.’’ The
draft guidance was prepared under the
auspices of the International Conference
on Harmonisation of Technical
Requirements for Registration of
Pharmaceuticals for Human Use (ICH).
The draft guidance provides principles
and examples of tools for quality risk
management that can be applied to all
aspects of pharmaceutical quality
throughout the lifecycle of drug
substances, drug products, and
biological and biotechnological
products. The draft guidance is
intended to enable regulators and
industry to make more effective and
consistent risk-based decisions.
DATES: Submit written or electronic
comments on the draft guidance by
October 7, 2005. General comments on
agency guidance documents are
welcome at any time.
ADDRESSES: Submit written comments
on the draft guidance 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.fda.gov/dockets/ecomments.
Submit written requests for single
copies of the draft guidance to the
Division of Drug Information (HFD–
240), Center for Drug Evaluation and
Research, Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857; or the Office of
Communication, Training, and
Manufacturers Assistance (HFM–40),
Center for Biologics Evaluation and
Research (CBER), Food and Drug
Administration, 1401 Rockville Pike,
Rockville, MD 20852–1448. The draft
guidance may also be obtained by mail
by calling the CBER Voice Information
System at 1–800–835–4709 or 301–827–
1800. Send two self-addressed adhesive
labels to assist the office in processing
your requests. See the SUPPLEMENTARY
INFORMATION section for electronic
access to the draft guidance document.
FOR FURTHER INFORMATION CONTACT:
Regarding the guidance: David J.
Horowitz, Center for Drug
Evaluation and Research (HFD–
300), Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301–827–
8910; Anna M. Flynn, Center for
Biologics Evaluation and Research
(HFM–610), Food and Drug
Administration, 1401 Rockville
Pike, Rockville, MD 20852, 301–
827–6201; Diana J. Kolaitis, Office
of Regulatory Affairs (HFR-NE1),
Food and Drug Administration,
E:\FR\FM\08AUN1.SGM
08AUN1
Agencies
[Federal Register Volume 70, Number 151 (Monday, August 8, 2005)]
[Notices]
[Page 45722]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-15544]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2005N-0045]
Agency Information Collection Activities; Announcement of Office
of Management and Budget Approval; Electronic Records; Electronic
Signatures
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing that a
collection of information entitled ``Electronic Records; Electronic
Signatures'' has been approved by the Office of Management and Budget
(OMB) under the Paperwork Reduction Act of 1995.
FOR FURTHER INFORMATION CONTACT: Karen Nelson, Office of Management
Programs (HFA-250), Food and Drug Administration, 5600 Fishers Lane,
Rockville, MD 20857,301-827-1482.
SUPPLEMENTARY INFORMATION: In the Federal Register of May 11, 2005 (70
FR 24818), 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 0910-0303.
The approval expires on July 31, 2008. A copy of the supporting
statement for this information collection is available on the Internet
at https://www.fda.gov/ohrms/dockets.
Dated: July 27, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05-15544 Filed 8-5-05; 8:45 am]
BILLING CODE 4160-01-S