Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Premarket Notification for a New Dietary Ingredient, 45722 [05-15545]

Download as PDF 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: 05-15545]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2005N-0031]


Agency Information Collection Activities; Announcement of Office 
of Management and Budget Approval; Premarket Notification for a New 
Dietary Ingredient

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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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
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