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