Agency Information Collection Activities; Proposed Collection; Comment Request; Substances Generally Recognized as Safe: Notification Procedure, 6894-6895 [E9-2861]

Download as PDF 6894 Federal Register / Vol. 74, No. 27 / Wednesday, February 11, 2009 / Notices TABLE 5—ESTIMATED ANNUAL RECORDKEEPING BURDEN FOR BIOLOGICS (CBER)1—Continued No. of Recordkeepers 21 CFR Section 312.160(c) 1 There 55 Reporting Burden 130,190,510 Recordkeeping Total 11,301,652 141,492,162 Dated: February 4, 2009. Jeffrey Shuren, Associate Commissioner for Policy and Planning. [FR Doc. E9–2846 Filed 2–10–09; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2009–N–0031] Agency Information Collection Activities; Proposed Collection; Comment Request; Substances Generally Recognized as Safe: Notification Procedure Food and Drug Administration, HHS. ACTION: Notice. 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 the information collection provisions of the Notification Procedure for Substances Generally Recognized as Safe. mstockstill on PROD1PC66 with NOTICES Total Annual Records 1.4 Hours per Record 77 Total Hours 0.5 38.5 are no capital and startup, or operation, maintenance, and purchase costs associated with the collection of information requirements. TABLE 6—TOTALS FOR ESTIMATED ANNUAL REPORTING AND RECORDKEEPING BURDENS FOR CDER AND CBER AGENCY: Annual Frequency per Recordkeeping VerDate Nov<24>2008 17:58 Feb 10, 2009 Jkt 217001 DATES: Submit written or electronic comments on the collection of information by April 13, 2009. ADDRESSES: Submit electronic comments on the collection of information to https:// www.regulations.gov. Submit written comments on the collection of information to the Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. All comments should be identified with the 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: 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, before submitting the collection to OMB for approval. To comply with this requirement, FDA is publishing notice of the proposed collection of information set forth in this document. With respect to the following collection of information, FDA invites comments on these topics: (1) Whether the proposed collection of information is necessary for the proper performance of FDA’s functions, including whether the information will have practical utility; (2) the accuracy of FDA’s estimate of the burden of the proposed collection of information, including the PO 00000 Frm 00040 Fmt 4703 Sfmt 4703 validity of the methodology and assumptions used; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology. Substances Generally Recognized as Safe: Notification Procedure—21 CFR 170.36 and 570.36 (OMB Control Number 0910–0342)—Extension Section 409 of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 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 of ‘‘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. FDA estimates the burden of this collection of information as follows: E:\FR\FM\11FEN1.SGM 11FEN1 6895 Federal Register / Vol. 74, No. 27 / Wednesday, February 11, 2009 / Notices TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN1 21 CFR Section No. of Respondents 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 4,500 1 There are no capital costs or operating and maintenance costs associated with this collection of information. TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN1 21 CFR Section No. of Recordkeepers Annual Frequency per Recordkeeping 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. Dated: February 4, 2009. Jeffrey Shuren, Associate Commissioner for Policy and Planning. [FR Doc. E9–2861 Filed 2–10–09; 8:45 am] mstockstill on PROD1PC66 with NOTICES BILLING CODE 4160–01–S VerDate Nov<24>2008 17:58 Feb 10, 2009 Jkt 217001 DEPARTMENT OF HEALTH AND HUMAN SERVICES in brackets in the heading of this document. Food and Drug Administration FOR FURTHER INFORMATION CONTACT: Denver Presley, Jr., Office of Information Management (HFA–710), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301–796–3793. [Docket No. FDA–2008–N–0571] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Guidance for Industry and Food and Drug Administration Staff; Compliance With the Medical Device User Fee and Modernization Act of 2002, as Amended: Prominent and Conspicuous Mark of Manufacturers on Single-Use Devices (formerly ‘‘Reprocessed Single-Use Device Labeling’’) 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 March 13, 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_submissions@OMB.eop.gov. All comments should be identified with the OMB control number 0910–0577. Also include the FDA docket number found PO 00000 Frm 00041 Fmt 4703 Sfmt 4703 In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance. SUPPLEMENTARY INFORMATION: Guidance for Industry and Food and Drug Administration Staff; Compliance With Section 301 of the Medical Device User Fee and Modernization Act of 2002, as Amended: Prominent and Conspicuous Mark of Manufacturers on Single-Use Devices (formerly ‘‘Reprocessed Single-Use Device Labeling’’) (Federal Food, Drug and Cosmetic Act, Section 502(u)) (OMB Control Number 0910–0577)—Extension Section 502 of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 352), among other things, establishes requirements that the label or labeling of a medical device must meet so that it is not misbranded and subject to regulatory action. Section 301 of the Medical Device User Fee and Modernization Act of 2002 (Public Law 107–250) amended section 502 of the act to add section 502(u) to require devices (both new and reprocessed) to bear prominently and conspicuously the name of the manufacturer, a generally recognized abbreviation of such name, or a unique and generally recognized symbol identifying the manufacturer. Thus, the name for this information collection activity has been changed to E:\FR\FM\11FEN1.SGM 11FEN1

Agencies

[Federal Register Volume 74, Number 27 (Wednesday, February 11, 2009)]
[Notices]
[Pages 6894-6895]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-2861]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Agency Information Collection Activities; Proposed Collection; 
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 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 the information collection 
provisions of the Notification Procedure for Substances Generally 
Recognized as Safe.

DATES: Submit written or electronic comments on the collection of 
information by April 13, 2009.

ADDRESSES: Submit electronic comments on the collection of information 
to https://www.regulations.gov. Submit written comments on the 
collection of information to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, 
Rockville, MD 20852. All comments should be identified with the 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: 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, 
before submitting the collection to OMB for approval. To comply with 
this requirement, FDA is publishing notice of the proposed collection 
of information set forth in this document.
    With respect to the following collection of information, FDA 
invites comments on these topics: (1) Whether the proposed collection 
of information is necessary for the proper performance of FDA's 
functions, including whether the information will have practical 
utility; (2) the accuracy of FDA's estimate of the burden of the 
proposed collection of information, including the validity of the 
methodology and assumptions used; (3) ways to enhance the quality, 
utility, and clarity of the information to be collected; and (4) ways 
to minimize the burden of the collection of information on respondents, 
including through the use of automated collection techniques, when 
appropriate, and other forms of information technology.

Substances Generally Recognized as Safe: Notification Procedure--21 CFR 
170.36 and 570.36 (OMB Control Number 0910-0342)--Extension

    Section 409 of the Federal Food, Drug, and Cosmetic Act (the act) 
(21 U.S.C. 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 of ``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.
    FDA estimates the burden of this collection of information as 
follows:

[[Page 6895]]



                                                      Table 1--Estimated Annual Reporting Burden\1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                           No. of        Annual Frequency  per      Total Annual        Hours Per
                   21 CFR Section                       Respondents             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\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                           No. of        Annual Frequency  per      Total Annual
                   21 CFR Section                      Recordkeepers         Recordkeeping            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                                                .................  .......................  .................  .................                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: February 4, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E9-2861 Filed 2-10-09; 8:45 am]
BILLING CODE 4160-01-S
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