Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Registration of Producers of Drugs and Listing of Drugs in Commercial Distribution, 6445 [05-2296]

Download as PDF Federal Register / Vol. 70, No. 24 / Monday, February 7, 2005 / Notices supplement containing a new dietary 6445 ingredient is in full compliance with the act. TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1 21 CFR Section Annual Frequency per Response No. of Respondents 190.6 71 1There Total Annual Responses 1 Hours per Response 71 1,420 are no capital costs or operating and maintenance costs associated with this collection of information. The agency believes that there will be minimal burden on the industry to generate data to meet the requirements of the premarket notification program because the agency is requesting only that information that the manufacturer or distributor should already have developed to satisfy itself that a dietary supplement containing a new dietary ingredient is in full compliance with the act. However, the agency estimates that extracting and summarizing the relevant information from the company’s files, and presenting it in a format that will meet the requirements of section 413 of the act will require a burden of approximately 20 hours of work per submission. This estimate is based on the annual average number of premarket notifications FDA received during the last 3 years (i.e., 2002 to 2004), which was 47. Forty-seven represents 24 more notifications than the agency received as an annual average during the previous 3-year period (i.e., 1999 to 2001). Therefore, FDA anticipates a similar upward trend will be seen in the annual average number of notifications the agency receives during 2005 to 2007, which is estimated to be 71. Dated: January 28, 2005. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. 05–2207 Filed 2–4–05; 8:45 am] that a collection of information entitled ‘‘Registration of Producers of Drugs and Listing of Drugs in Commercial Distribution’’ 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 July 19, 2004 (69 FR 42999), 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 0910–0045. The approval expires on December 31, 2007. A copy of the supporting statement for this information collection is available on the Internet at https://www.fda.gov/ ohrms/dockets. Dated: January 28, 2005. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. 05–2296 Filed 2–4–05; 8:45 am] BILLING CODE 4160–01–S BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Food and Drug Administration [Docket No. 2004N–0093] [Docket No. 2005N–0032] Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Registration of Producers of Drugs and Listing of Drugs in Commercial Distribution Agency Information Collection Activities; Proposed Collection; Comment Request; Food Canning Establishment Registration, Process Filing, and Recordkeeping for Acidified Foods and Thermally Processed LowAcid Foods in Hermetically Sealed Containers AGENCY: Food and Drug Administration, HHS. ACTION: 20 Total Hours AGENCY: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing VerDate jul<14>2003 21:04 Feb 04, 2005 Jkt 205001 Food and Drug Administration, HHS. ACTION: PO 00000 Notice. Frm 00039 Fmt 4703 Sfmt 4703 SUMMARY: The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on reporting and recordkeeping requirements for firms that process acidified foods and thermally processed low-acid foods in hermetically sealed containers. DATES: Submit written or electronic comments on the collection of information by April 8, 2005. ADDRESSES: Submit written comments 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. All comments should be identified with the docket number found in brackets in the heading of this document. 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: Under the PRA (44 U.S.C. 3501–3520), Federal agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. ‘‘Collection of information’’ is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal agencies to provide a 60-day notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, E:\FR\FM\07FEN1.SGM 07FEN1

Agencies

[Federal Register Volume 70, Number 24 (Monday, February 7, 2005)]
[Notices]
[Page 6445]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-2296]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2004N-0093]


Agency Information Collection Activities; Announcement of Office 
of Management and Budget Approval; Registration of Producers of Drugs 
and Listing of Drugs in Commercial Distribution

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is announcing that a 
collection of information entitled ``Registration of Producers of Drugs 
and Listing of Drugs in Commercial Distribution'' 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 July 19, 2004 (69 
FR 42999), 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 0910-0045. 
The approval expires on December 31, 2007. A copy of the supporting 
statement for this information collection is available on the Internet 
at https://www.fda.gov/ohrms/dockets.

    Dated: January 28, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05-2296 Filed 2-4-05; 8:45 am]
BILLING CODE 4160-01-S
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