Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Requests for Inspection by an Accredited Person Under the Inspection by Accredited Persons Program, 54393 [05-18222]

Download as PDF Federal Register / Vol. 70, No. 177 / Wednesday, September 14, 2005 / Notices 54393 TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1 No. of Respondents 21 CFR Section Annual Frequency per Response 860.123 1There 6 1 Hours per Response 6 Total Hours 500 3,000 are no capital costs or operating and maintenance costs associated with this collection of information. Based on current trends and actual reclassification petitions received, FDA anticipates that six petitions will be submitted each year. The time required to prepare and submit a reclassification petition, including the time needed to assemble supporting data, averages 500 hours per petition. This average is based upon estimates by FDA administrative and technical staff that are familiar with the requirements for submission of a reclassification petition, have consulted and advised manufacturers on these requirements, and have reviewed the documentation submitted. Dated: September 7, 2005. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. 05–18221 Filed 9–13–05; 8:45 am] BILLING CODE 4160–01–S BILLING CODE 4160–01–S Food and Drug Administration [Docket No. 2004D–0251] Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Requests for Inspection by an Accredited Person Under the Inspection by Accredited Persons Program AGENCY: Food and Drug Administration, HHS. Notice. 16:17 Sep 13, 2005 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2005N–0186] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; State Enforcement Notifications AGENCY: SUMMARY: The Food and Drug Administration (FDA) is announcing that a collection of information entitled ‘‘Requests for Inspection by an Accredited Person Under the Inspection by Accredited Persons Program’’ 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 VerDate Aug<18>2005 Administration, 5600 Fishers Lane, Rockville, MD 20857, 301–827–1223. SUPPLEMENTARY INFORMATION: In the Federal Register of June 7, 2005 (70 FR 33179), 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 0910–0569. The approval expires on August 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: September 7, 2005. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. 05–18222 Filed 9–13–05; 8:45 am] DEPARTMENT OF HEALTH AND HUMAN SERVICES ACTION: Total Annual Responses Jkt 205001 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. DATES: Fax written comments on the collection of information by October 14, 2005. PO 00000 Frm 00044 Fmt 4703 Sfmt 4703 OMB is still experiencing significant delays in the regular mail, including first class and express mail, and messenger deliveries are not being accepted. 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: Fumie Yokota, Desk Officer for FDA, FAX: 202–395–6974. 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 compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance. ADDRESSES: State Enforcement Notifications—21 CFR 100.2(d) (OMB Control Number 0910–0275)—Extension Section 310(b) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 337(b)) authorizes States to enforce certain sections of the act in their own names, but provides that States must notify FDA before doing so. Section 100.2(d) (21 CFR 100.2(d)) sets forth the information that a State must provide to FDA in a letter of notification when it intends to take enforcement action under the act against a particular food located in the State. The information required under § 100.2(d) will enable FDA to identify the food against which the State intends to take action and advise the State whether Federal action has been taken against it. With certain narrow exceptions, Federal enforcement action precludes State action under the act. In the Federal Register of June 20, 2005 (70 FR 35446), FDA published a 60-day notice requesting public comment on the information collection provisions. FDA received no comments. FDA estimates the burden of this collection of information as follows: E:\FR\FM\14SEN1.SGM 14SEN1

Agencies

[Federal Register Volume 70, Number 177 (Wednesday, September 14, 2005)]
[Notices]
[Page 54393]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-18222]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2004D-0251]


Agency Information Collection Activities; Announcement of Office 
of Management and Budget Approval; Requests for Inspection by an 
Accredited Person Under the Inspection by Accredited Persons Program

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 ``Requests for Inspection by an 
Accredited Person Under the Inspection by Accredited Persons Program'' 
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 June 7, 2005 (70 
FR 33179), 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 0910-0569. 
The approval expires on August 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: September 7, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05-18222 Filed 9-13-05; 8:45 am]
BILLING CODE 4160-01-S
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