Agency Information Collection Activities; Proposed Collection; Comment Request; Food Additive Petitions, 51287-51288 [E9-24047]
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Federal Register / Vol. 74, No. 192 / Tuesday, October 6, 2009 / Notices
51287
TABLE 2.—ESTIMATED RECORDKEEPING ANNUAL BURDEN1—Continued
No. of
Recordkeepers
Annual Frequency
per Recordkeeping
Total Annual
Records
Hours per
Record
Total
660
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
The annual burden estimate for this
information collection is 3,204 hours.
The estimated reporting burden for this
collection is 2,544 hours, and the
estimated recordkeeping burden is 660
hours.
In the Federal Register of April 20,
2009 (74 FR 17962), FDA published a
60-day notice requesting public
comment on the proposed collection of
information. No comments were
received. However, in the period of time
since the 60-day notice was drafted,
there was a determination of public
health emergency involving the 2009
H1N1 virus and multiple declarations
supporting the issuance of EUAs. As a
result of this increased activity and the
likelihood of a continued increase in the
number of EUA and pre-EUA
submissions, on its own initiative, FDA
is providing estimates based on the
number of reports that the agency
received in the past year.
Dated: September 29, 2009.
David Horowitz,
Assistant Commissioner for Policy.
[FR Doc. E9–24048 Filed 10–5–09; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2009–N–0465]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Food Additive
Petitions
AGENCY:
Food and Drug Administration,
HHS.
jlentini on DSKJ8SOYB1PROD with NOTICES
ACTION:
Total Hours
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
VerDate Nov<24>2008
16:15 Oct 05, 2009
Jkt 220001
public comment in response to the
notice. This notice solicits comments on
food additive petitions regarding animal
feed.
DATES: Submit written or electronic
comments on the collection of
information by December 7, 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:
Denver Presley Jr., Office of Information
Management (HFA–710), Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301–796–3793.
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
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Fmt 4703
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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.
Food Additive Petitions—21 CFR Part
571 (OMB Control Number 0910–
0546)—Extension
Section 409(a) of the Federal Food,
Drug, and Cosmetic Act (the act) (21
U.S.C. 348(a)) provides that a food
additive shall be deemed to be unsafe
unless its use is permitted by a
regulation which prescribes the
condition(s) under which it may safely
be used, or unless it is exempted by
regulation for investigational use.
Section 409(b) of the act specifies the
information that must be submitted by
a petition in order to establish the safety
of a food additive and to secure the
issuance of a regulation permitting its
use.
To implement the provision of section
409 of the act, procedural regulations
have been issued under part 571 (21
CFR part 571). These procedural
regulations are designed to specify more
thoroughly the information that must be
submitted to meet the requirement set
down in broader terms by the law. The
regulations add no substantive
requirements to those indicated in the
law, but seek to explain the
requirements and provide a standard
format for submission of petitions, that
when implemented, will speed up the
time for processing. Labeling
requirements for food additives
intended for animal consumption are
also set forth in various regulations
contained in 21 CFR parts 573, 582, and
584. The labeling regulations are
considered by FDA to be crossreferenced to § 571.1, which is the
subject of this same OMB clearance for
food additive petitions.
FDA estimates the burden of this
collection of information as follows:
E:\FR\FM\06OCN1.SGM
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51288
Federal Register / Vol. 74, No. 192 / Tuesday, October 6, 2009 / Notices
TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1
No. of
Respondents
Annual Frequency
per Response
Total Annual
Responses
571.1(c) moderate category
1
1
1
3,000
3,000
571.1(c) complex category
1
1
1
10,000
10,000
571.6 amendment of petition
2
2
4
1,300
5,200
21 CFR Section
Hours per
Response
Total Hours
1 There
18,200
are no capital costs or operating and maintenance costs associated with this collection of information.
FDA derived the annual reporting
burden estimate for the different
categories as follows:
Section 571.1(c)—moderate category:
For food additive petition without
complex chemistry, manufacturing,
efficacy, or safety issues, the estimated
time requirement per petition is
approximately 3,000 hours. An average
of 1 (one) petitions of this type is
received on an annual basis, resulting in
a burden of 3,000 hours.
Section 571.1(c)—complex category:
For a food additive petition with
complex chemistry, manufacturing,
efficacy, and/or safety issues, the
estimated time requirement per petition
is approximately 10,000 hours. An
average of 1 (one) petition of this type
is received on an annual basis, resulting
in a burden of 10,000 hours.
Section 571.6: For a food additive
petition amendment, the estimated time
requirement per petition is
approximately 1,300 hours. An average
of 4 (four) petitions of this type is
received on an annual basis, resulting in
a burden of 5,200 hours.
Thus, the estimated total annual
burden for this information collection is
18,200 hours.
Dated: September 29, 2009.
David Horowitz,
Assistant Commissioner for Policy.
[FR Doc. E9–24047 Filed 10–05–09; 8:45 am]
and Human Services to share and
coordinate information on existing
research activities, and make
recommendations to the Secretary
DHHS, the National Institutes of Health
and other Federal agencies regarding
how to improve existing research
programs.
The Committee’s primary mission is
to facilitate the efficient and effective
exchange of information on breast
cancer research activities among the
member agencies, and to coordinate
solicitation of proposals for
collaborative, multidisciplinary
research, including proposals to
evaluate environmental and genomic
factors that may be related to the
etiology of breast cancer.
Duration of this committee is two
years from the date the Charter is filed.
Francis S. Collins,
Director, National Institutes of Health.
[FR Doc. E9–23974 Filed 10–5–09; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
BILLING CODE 4160–01–S
[Docket Nos. FDA–2009–M–0033, FDA–
2009–M–0016, FDA–2009–M–0034, FDA–
2009–M–0049, FDA–2009–M–0071, FDA–
2009–M–0127, FDA–2009–M–0128, FDA–
2009–M–0135, FDA–2009–M–0159]
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Medical Devices; Availability of Safety
and Effectiveness Summaries for
Premarket Approval Applications
AGENCY:
National Institutes of Health
Food and Drug Administration,
HHS.
Notice.
Notice of Establishment
jlentini on DSKJ8SOYB1PROD with NOTICES
Total Hours
ACTION:
Pursuant to the Federal Advisory
Committee Act, as amended (5 U.S.C.
Appendix 2), the Director, National
Institutes of Health (NIH), announces
the establishment of the Interagency
Breast Cancer and Environmental
Research Coordinating Committee
(Committee).
The Committee shall coordinate all
efforts within the Department of Health
SUMMARY: The Food and Drug
Administration (FDA) is publishing a
list of premarket approval applications
(PMAs) that have been approved. This
list is intended to inform the public of
the availability of safety and
effectiveness summaries of approved
PMAs through the Internet and the
agency’s Division of Dockets
Management.
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ADDRESSES: Submit written requests for
copies of summaries of safety and
effectiveness data to the Division of
Dockets Management (HFA–305), Food
and Drug Administration, 5630 Fishers
Lane, rm. 1061, Rockville, MD 20852.
Please cite the appropriate docket
number as listed in table 1 of this
document when submitting a written
request. See the SUPPLEMENTARY
INFORMATION section for electronic
access to the summaries of safety and
effectiveness.
FOR FURTHER INFORMATION CONTACT:
Nicole Wolanski, Center for Devices and
Radiological Health (HFZ–402), Food
and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, rm. 1650,
Silver Spring, MD 20993, 301–796–
6570.
SUPPLEMENTARY INFORMATION:
I. Background
In the Federal Register of January 30,
1998 (63 FR 4571), FDA published a
final rule that revised 21 CFR 814.44(d)
and 814.45(d) to discontinue individual
publication of PMA approvals and
denials in the Federal Register. Instead,
the agency now posts this information
on the Internet on FDA’s home page at
https://www.fda.gov. FDA believes that
this procedure expedites public
notification of these actions because
announcements can be placed on the
Internet more quickly than they can be
published in the Federal Register, and
FDA believes that the Internet is
accessible to more people than the
Federal Register.
In accordance with section 515(d)(4)
and (e)(2) of the Federal Food, Drug, and
Cosmetic Act (the act) (21 U.S.C.
360e(d)(4) and (e)(2)), notification of an
order approving, denying, or
withdrawing approval of a PMA will
continue to include a notice of
opportunity to request review of the
order under section 515(g) of the act.
The 30-day period for requesting
reconsideration of an FDA action under
§ 10.33(b) (21 CFR 10.33(b)) for notices
announcing approval of a PMA begins
on the day the notice is placed on the
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]]>Agencies
[Federal Register Volume 74, Number 192 (Tuesday, October 6, 2009)]
[Notices]
[Pages 51287-51288]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-24047]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2009-N-0465]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Food Additive Petitions
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 food additive petitions
regarding animal feed.
DATES: Submit written or electronic comments on the collection of
information by December 7, 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: Denver Presley Jr., Office of
Information Management (HFA-710), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857, 301-796-3793.
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.
Food Additive Petitions--21 CFR Part 571 (OMB Control Number 0910-
0546)--Extension
Section 409(a) of the Federal Food, Drug, and Cosmetic Act (the
act) (21 U.S.C. 348(a)) provides that a food additive shall be deemed
to be unsafe unless its use is permitted by a regulation which
prescribes the condition(s) under which it may safely be used, or
unless it is exempted by regulation for investigational use. Section
409(b) of the act specifies the information that must be submitted by a
petition in order to establish the safety of a food additive and to
secure the issuance of a regulation permitting its use.
To implement the provision of section 409 of the act, procedural
regulations have been issued under part 571 (21 CFR part 571). These
procedural regulations are designed to specify more thoroughly the
information that must be submitted to meet the requirement set down in
broader terms by the law. The regulations add no substantive
requirements to those indicated in the law, but seek to explain the
requirements and provide a standard format for submission of petitions,
that when implemented, will speed up the time for processing. Labeling
requirements for food additives intended for animal consumption are
also set forth in various regulations contained in 21 CFR parts 573,
582, and 584. The labeling regulations are considered by FDA to be
cross-referenced to Sec. 571.1, which is the subject of this same OMB
clearance for food additive petitions.
FDA estimates the burden of this collection of information as
follows:
[[Page 51288]]
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
----------------------------------------------------------------------------------------------------------------
571.1(c) moderate category 1 1 1 3,000 3,000
----------------------------------------------------------------------------------------------------------------
571.1(c) complex category 1 1 1 10,000 10,000
----------------------------------------------------------------------------------------------------------------
571.6 amendment of petition 2 2 4 1,300 5,200
----------------------------------------------------------------------------------------------------------------
Total Hours 18,200
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
FDA derived the annual reporting burden estimate for the different
categories as follows:
Section 571.1(c)--moderate category: For food additive petition
without complex chemistry, manufacturing, efficacy, or safety issues,
the estimated time requirement per petition is approximately 3,000
hours. An average of 1 (one) petitions of this type is received on an
annual basis, resulting in a burden of 3,000 hours.
Section 571.1(c)--complex category: For a food additive petition
with complex chemistry, manufacturing, efficacy, and/or safety issues,
the estimated time requirement per petition is approximately 10,000
hours. An average of 1 (one) petition of this type is received on an
annual basis, resulting in a burden of 10,000 hours.
Section 571.6: For a food additive petition amendment, the
estimated time requirement per petition is approximately 1,300 hours.
An average of 4 (four) petitions of this type is received on an annual
basis, resulting in a burden of 5,200 hours.
Thus, the estimated total annual burden for this information
collection is 18,200 hours.
Dated: September 29, 2009.
David Horowitz,
Assistant Commissioner for Policy.
[FR Doc. E9-24047 Filed 10-05-09; 8:45 am]
BILLING CODE 4160-01-S
