Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Substances Generally Recognized as Safe: Notification Procedure, 21808-21809 [E9-10964]

Download as PDF 21808 Federal Register / Vol. 74, No. 89 / Monday, May 11, 2009 / Notices ACTION: Notice of request for comments regarding a renewal to an existing OMB clearance. SUMMARY: Under the provisions of the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35), the General Services Administration will be submitting to the Office of Management and Budget (OMB) a request to review and approve a renewal of a currently approved information collection requirement regarding GSA Form 527, Contractor’s Qualifications and Financial Information. A request for public comments was published in the Federal Register at 73 FR 79130, December 24, 2008. No comments were received. Public comments are particularly invited on: Whether this collection of information is necessary and whether it will have practical utility; whether our estimate of the public burden of this collection of information is accurate, and based on valid assumptions and methodology; ways to enhance the quality, utility, and clarity of the information to be collected. DATES: Submit comments on or before: June 10, 2009. FOR FURTHER INFORMATION CONTACT: Norma Tolson, Accountant, Office of the Chief Financial Officer, Office of Finance, at (202) 208–0584 or via email to norma.tolson@gsa.gov. ADDRESSES: Submit comments regarding this burden estimate or any other aspect of this collection of information, including suggestions for reducing this burden to the GSA Desk Officer, OMB, Room 10236, NEOB, Washington, DC 20503, and a copy to the Regulatory Secretariat (VPR), General Services Administration, 1800 F Street, NW., Room 4041, Washington, DC 20405. Please cite OMB Control Number 3090– 0007, GSA Form 527, Contractor’s Qualifications and Financial Information, in all correspondence. SUPPLEMENTARY INFORMATION: A. Purpose GSA Form 527 is used to determine the financial capability of prospective contractors as to whether they meet the financial responsibility standards in accordance with the Federal Acquisition Regulation and the General Services Administration Acquisition Manual. B. Annual Reporting Burden Respondents: 2,940. Responses per Respondent: 1.2. Total Responses: 3,528. Hours per Response: 2.5. Total Burden Hours: 8,820. Obtaining Copies of Proposals: Requesters may obtain a copy of the VerDate Nov<24>2008 15:05 May 08, 2009 Jkt 217001 information collection documents from the General Services Administration, Regulatory Secretariat (VPR), 1800 F Street, NW., Room 4041, Washington, DC 20405, telephone (202) 501–4755. Please cite OMB Control No. 3090–0007, GSA Form 527, Contractor’s Qualifications and Financial Information, in all correspondence. Dated: April 29, 2009. Casey Coleman, Chief Information Officer. [FR Doc. E9–10949 Filed 5–8–09; 8:45 am] BILLING CODE 6820–34–P 533–6800 (this is not a toll-free number). Information requests can also be submitted by e-mail to OCAS@CDC.GOV. Christine M. Branche, Acting Director, National Institute for Occupational Safety and Health. [FR Doc. E9–10828 Filed 5–8–09; 8:45 am] BILLING CODE 4163–19–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2009–N–0031] DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institute for Occupational Safety and Health; Final Effect of Designation of a Class of Employees for Addition to the Special Exposure Cohort National Institute for Occupational Safety and Health (NIOSH), Department of Health and Human Services (HHS). ACTION: Notice. AGENCY: SUMMARY: HHS gives notice concerning the final effect of the HHS decision to designate a class of employees at the Hood Building in Cambridge, Massachusetts, as an addition to the Special Exposure Cohort (SEC) under the Energy Employees Occupational Illness Compensation Program Act of 2000. On March 31, 2009, as provided for under 42 U.S.C. 7384q(b), the Secretary of HHS designated the following class of employees as an addition to the SEC: All employees of the DOE, its predecessor agencies, and their contractors and subcontractors who worked in the Hood Building in Cambridge, Massachusetts, from May 9, 1946 through December 31, 1963, for a number of work days aggregating at least 250 work days, occurring either solely under this employment or in combination with work days within the parameters established for one or more other classes of employees included in the SEC. This designation became effective on April 30, 2009, as provided for under 42 U.S.C. 7384l(14)(C). Hence, beginning on April 30, 2009, members of this class of employees, defined as reported in this notice, became members of the Special Exposure Cohort. FOR FURTHER INFORMATION CONTACT: Larry Elliott, Director, Office of Compensation Analysis and Support, National Institute for Occupational Safety and Health (NIOSH), 4676 Columbia Parkway, MS C–46, Cincinnati, OH 45226, Telephone 513– PO 00000 Frm 00034 Fmt 4703 Sfmt 4703 Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Substances Generally Recognized as Safe: Notification Procedure AGENCY: 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 June 10, 2009. 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 oira_submission@omb.eop.gov. All comments should be identified with the OMB control number 0910–0342. Also include the FDA docket number found in brackets in the heading of this document. 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 compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance. Substances Generally Recognized as Safe: Notification Procedure—(OMB Control Number 0910–0342)—Extension Section 409 of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. E:\FR\FM\11MYN1.SGM 11MYN1 21809 Federal Register / Vol. 74, No. 89 / Monday, May 11, 2009 / Notices 348) establishes a premarket approval requirement for ‘‘food additives;’’ section 201(s) of the act (21 U.S.C. 321) provides an exemption from the definition off ‘‘food additive’’ and thus from the premarket approval requirement, for uses of substances that are Generally Recognized as Safe (GRAS) by qualified experts. In April 1997, FDA proposed a voluntary procedure whereby manufacturers would notify FDA about a view that a particular use (or uses) of a substance is not subject to the statutory premarket approval requirements based on a determination that such use is GRAS (62 FR 18938, April 17, 1997). Proposed §§ 170.36 and 570.36 provide a standard format for the voluntary submission of a notice. The notice would include a detailed summary of the data and information that support the GRAS determination, and the notifier would maintain a record of such data and information. FDA would make the information describing the subject of the GRAS notice, and the agency’s response to the notice, available in a publicly accessible file; the entire GRAS notice would be publicly available consistent with the Freedom of Information Act and other Federal disclosure statutes. Description of Respondents: Manufacturers of Substances Used in Food and Feed. In the Federal Register of February 11, 2009 (74 FR 6894), FDA published a 60-day notice requesting public comment on the information collection provisions. No comments were received. FDA estimates the burden of this collection of information as follows: TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1 No. of Respondents 21 CFR Section Annual Frequency per Response Total Annual Responses Hours per Response Total Hours 170.36 25 1 25 150 3,750 570.36 5 1 5 150 750 Total 1 There 4,500 are no capital costs or operating and maintenance costs associated with this collection of information. TABLE 2.—ESTIMATED ANNUAL RECORDKEEPING BURDEN1 Annual Frequency per Recordkeeping No. of Recordkeepers 21 CFR Section Total Annual Records Hours per Record Total Hours 170.36(c)(v) 25 1 25 15 375 570.36(c)(v) 5 1 5 15 75 Total 1 There 450 are no capital costs or operating and maintenance costs associated with this collection of information. In the proposed rule, FDA estimated that the Center for Food Safety and Applied Nutrition (CFSAN) would receive approximately 50 GRAS notices per year and that the Center for Veterinary Medicine (CVM) would receive approximately 10 GRAS notices per year. Although FDA requested comment on this estimate, the comments did not provide useful information regarding this issue. Therefore, FDA evaluated the number of notices received by CFSAN to date. CFSAN received 274 GRAS notices during the 11–year period from 1998 through 2008, for an average of approximately 25 GRAS notices per year. Based on this experience, FDA is revising its estimate of the annual number of GRAS notices submitted to CFSAN to be 25 or less. FDA also is revising its estimate of the annual number of GRAS notices submitted to CVM to be 5 or less. VerDate Nov<24>2008 15:05 May 08, 2009 Jkt 217001 Dated: May 4, 2009. Jeffrey Shuren Associate Commissioner for Policy. [FR Doc. E9–10964 Filed 5–8–09; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention [60Day–09–0733] Proposed Data Collections Submitted for Public Comment and Recommendations In compliance with the requirement of Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995 for opportunity for public comment on proposed data collection projects, the Centers for Disease Control and Prevention (CDC) will publish periodic summaries of proposed projects. To request more information on the proposed projects or to obtain a copy of the data collection plans and PO 00000 Frm 00035 Fmt 4703 Sfmt 4703 instruments, call 404–639–5960 and send comments to Maryam I. Daneshvar, CDC Acting Reports Clearance Officer, 1600 Clifton Road, MS–D74, Atlanta, GA 30333 or send an e-mail to omb@cdc.gov. Comments are invited 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) ways to enhance 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. Written comments should be received within 60 days of this notice. Proposed Project CDC Early Hearing Detection and Intervention Hearing Screening and Follow-up Survey, OMB #0920–0733— E:\FR\FM\11MYN1.SGM 11MYN1

Agencies

[Federal Register Volume 74, Number 89 (Monday, May 11, 2009)]
[Notices]
[Pages 21808-21809]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-10964]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-N-0031]

Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Substances Generally
Recognized as Safe: Notification Procedure

AGENCY: 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 June
10, 2009.

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 oira_submission@omb.eop.gov. All
comments should be identified with the OMB control number 0910-0342.
Also include the FDA docket number found in brackets in the heading of
this document.

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 compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.

Substances Generally Recognized as Safe: Notification Procedure--(OMB
Control Number 0910-0342)--Extension

Section 409 of the Federal Food, Drug, and Cosmetic Act (the act)
(21 U.S.C.

[[Page 21809]]

348) establishes a premarket approval requirement for ``food
additives;'' section 201(s) of the act (21 U.S.C. 321) provides an
exemption from the definition off ``food additive'' and thus from the
premarket approval requirement, for uses of substances that are
Generally Recognized as Safe (GRAS) by qualified experts. In April
1997, FDA proposed a voluntary procedure whereby manufacturers would
notify FDA about a view that a particular use (or uses) of a substance
is not subject to the statutory premarket approval requirements based
on a determination that such use is GRAS (62 FR 18938, April 17, 1997).
Proposed Sec. Sec. 170.36 and 570.36 provide a standard format for the
voluntary submission of a notice. The notice would include a detailed
summary of the data and information that support the GRAS
determination, and the notifier would maintain a record of such data
and information. FDA would make the information describing the subject
of the GRAS notice, and the agency's response to the notice, available
in a publicly accessible file; the entire GRAS notice would be publicly
available consistent with the Freedom of Information Act and other
Federal disclosure statutes.
Description of Respondents: Manufacturers of Substances Used in
Food and Feed.
In the Federal Register of February 11, 2009 (74 FR 6894), FDA
published a 60-day notice requesting public comment on the information
collection provisions. No comments were received.
FDA estimates the burden of this collection of information as
follows:

Table 1.--Estimated Annual Reporting Burden\1\
----------------------------------------------------------------------------------------------------------------
No. of Annual Frequency Total Annual Hours per
21 CFR Section Respondents per Response Responses Response Total Hours
----------------------------------------------------------------------------------------------------------------
170.36 25 1 25 150 3,750
----------------------------------------------------------------------------------------------------------------
570.36 5 1 5 150 750
----------------------------------------------------------------------------------------------------------------
Total 4,500
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.

Table 2.--Estimated Annual Recordkeeping Burden\1\
----------------------------------------------------------------------------------------------------------------
Annual Frequency
21 CFR Section No. of per Total Annual Hours per Record Total Hours
Recordkeepers Recordkeeping Records
----------------------------------------------------------------------------------------------------------------
170.36(c)(v) 25 1 25 15 375
----------------------------------------------------------------------------------------------------------------
570.36(c)(v) 5 1 5 15 75
----------------------------------------------------------------------------------------------------------------
Total 450
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.

In the proposed rule, FDA estimated that the Center for Food Safety
and Applied Nutrition (CFSAN) would receive approximately 50 GRAS
notices per year and that the Center for Veterinary Medicine (CVM)
would receive approximately 10 GRAS notices per year. Although FDA
requested comment on this estimate, the comments did not provide useful
information regarding this issue. Therefore, FDA evaluated the number
of notices received by CFSAN to date. CFSAN received 274 GRAS notices
during the 11-year period from 1998 through 2008, for an average of
approximately 25 GRAS notices per year. Based on this experience, FDA
is revising its estimate of the annual number of GRAS notices submitted
to CFSAN to be 25 or less. FDA also is revising its estimate of the
annual number of GRAS notices submitted to CVM to be 5 or less.

Dated: May 4, 2009.
Jeffrey Shuren
Associate Commissioner for Policy.
[FR Doc. E9-10964 Filed 5-8-09; 8:45 am]
BILLING CODE 4160-01-S

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