Agency Information Collection Activities; Proposed Collection; Comment Request; Filing Objections and Requests for a Hearing on a Regulation or Order, 2080-2081 [E9-574]
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Federal Register / Vol. 74, No. 9 / Wednesday, January 14, 2009 / Notices
Record Retention Requirements for the
Soy Protein and Risk of Coronary Heart
Disease Health Claim—(OMB Control
Number 0910–0428—Extension)
Section 403(r)(3)(A)(i) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C.
343(r)(3)(A)(i)) provides for the use of
food label statements characterizing a
relationship of any nutrient of the type
required to be in the label or labeling of
the food to a disease or a health-related
condition only where that statement
meets the requirements of the
regulations issued by the Secretary of
Health and Human Services to authorize
the use of such a health claim. Section
101.82 (§ 101.82) of FDA’s regulations
authorizes a health claim for food labels
about soy protein and the risk of
coronary heart disease. To bear the soy
protein/coronary heart disease health
claim, foods must contain at least 6.25
grams of soy protein per reference
amount customarily consumed.
Analytical methods for measuring total
protein can be used to quantify the
amount of soy protein in foods that
contain soy as the sole source of protein.
However, at the present time there is no
validated analytical methodology
available to quantify the amount of soy
protein in foods that contain other
sources of protein. For these latter
foods, FDA must rely on information
known only to the manufacturer to
assess compliance with the requirement
that the foods contain the qualifying
amount of soy protein. Thus, FDA
requires manufacturers to have and keep
records to substantiate the amount of
soy protein in a food that bears the
health claim and contains sources of
protein other than soy, and to make
such records available to appropriate
regulatory officials upon written
request. The information collected
includes nutrient databases or analyses,
recipes or formulations, purchase orders
for ingredients, or any other information
that reasonably substantiates the ratio of
soy protein to total protein.
In the Federal Register of October 23,
2008 (73 FR 63157), 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 RECORDKEEPING BURDEN1
101.82(c)(2)(ii)(B)
1 There
25
Total Annual
Records
1
Hours per
Record
25
Total Hours
1
25
are no capital costs or operating and maintenance costsassociated with this collection of information.
Based upon the agency’s experience
with the use of health claims, FDA
estimates that only about 25 firms
would be likely to market products
bearing a soy protein/coronary heart
disease health claim and that only,
perhaps, one of each firm’s products
might contain non-soy sources of
protein along with soy protein. The
records required to be retained by
§ 101.82(c)(2)(ii)(B) are the records, e.g.,
the formulation or recipe, that a
manufacturer has and maintains as a
normal course of its doing business.
Thus, the burden to the food
manufacturer is that involved in
assembling and providing the records to
appropriate regulatory officials for
review or copying.
Dated: January 7, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and
Planning.
[FR Doc. E9–573 Filed 1–13–09; 8:45 am]
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per
Recordkeeping
No. of
Recordkeepers
21 CFR Section
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2008–N–0653]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Filing Objections
and Requests for a Hearing on a
Regulation or Order
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
requirements for filing objections and
requests for a hearing on a regulation or
order.
DATES: Submit written or electronic
comments on the collection of
information by March 16, 2009.
ADDRESSES: Submit electronic
comments on the collection of
PO 00000
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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.
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
SUPPLEMENTARY INFORMATION:
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Federal Register / Vol. 74, No. 9 / Wednesday, January 14, 2009 / Notices
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.
Filing Objections and Requests for a
Hearing on a Regulation or Order—21
CFR Part 12 (OMB Control Number
0910–0184)—Extension
The regulations in 21 CFR 12.22,
issued under section 701(e)(2) of the
Federal Food, Drug, and Cosmetic Act
(the act) (21 U.S.C. 371(e)(2)), set forth
the instructions for filing objections and
requests for a hearing on a regulation or
order under § 12.20(d) (21CFR 12.20(d)).
Objections and requests must be
submitted within the time specified in
§ 12.20(e). Each objection, for which a
hearing has been requested, must be
separately numbered and specify the
provision of the regulation or the
proposed order. In addition, each
objection must include a detailed
description and analysis of the factual
information and any other document,
with some exceptions, supporting the
objection. Failure to include this
information constitutes a waiver of the
right to a hearing on that objection. FDA
uses the description and analysis to
determine whether a hearing request is
justified. The description and analysis
may be used only for the purpose of
determining whether a hearing has been
justified under 21 CFR 12.24 and do not
limit the evidence that may be
presented if a hearing is granted.
Respondents to this information
collection are those parties that may be
adversely affected by an order or
regulation.
FDA estimates the burden of this
collection of information as follows:
TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1
21 CFR Section
No. of
Respondents
12.22
1There
5
Total Annual
Responses
1
Hours per
Response
5
Total Hours
20
100
are no capital costs or operating and maintenance costs associated with this collection of information.
The burden estimate for this
collection of information is based on
past filings. Agency personnel,
responsible for processing the filing of
objections and requests for a public
hearing on a specific regulation or order,
estimate approximately five requests are
received by the agency annually, with
each requiring approximately 20 hours
of preparation time.
Please note that on January 15, 2008,
the FDA Division of Dockets
Management Web site transitioned to
the Federal Dockets Management
System (FDMS). FDMS is a
Government-wide, electronic docket
management system. Electronic
comments or submissions will be
accepted by FDA only through FDMS at
https://www.regulations.gov.
Dated: January 7, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and
Planning.
[FR Doc. E9–574 Filed 1–13–09; 8:45 am]
BILLING CODE 4160–01–S
sroberts on PROD1PC70 with NOTICES
Annual Frequency
per Response
VerDate Nov<24>2008
21:01 Jan 13, 2009
Jkt 217001
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2009–N–0664]
Pulmonary-Allergy Drugs Advisory
Committee; Notice of Meeting
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
This notice announces a forthcoming
meeting of a public advisory committee
of the Food and Drug Administration
(FDA). The meeting will be open to the
public.
Name of Committee: PulmonaryAllergy Drugs Advisory Committee.
General Function of the Committee:
To provide advice and
recommendations to the agency on
FDA’s regulatory issues.
Date and Time: The meeting will be
held on February 4, 2009, from 8:30 a.m.
to 5 p.m.
Location: Hilton Washington DC
North/ Gaithersburg, The Ballrooms,
620 Perry Pkwy., Gaithersburg, MD. The
hotel telephone number is 301–977–
8900.
Contact Person: Kristine T. Khuc,
Center for Drug Evaluation and Research
(HFD–21), Food and Drug
Administration, 5630 Fishers Lane (for
express delivery, 5630 Fishers Lane,rm.
1093), Rockville, MD 20857, 301–827–
PO 00000
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7001, Fax: 301–827–6776, e-mail:
Kristine.Khuc@fda.hhs.gov, or FDA
Advisory Committee Information Line,
1–800–741–8138 (301–443–0572 in the
Washington, DC area), code
3014512545. Please call the Information
Line for up-to-date information on this
meeting. A notice in the Federal
Register about last minute modifications
that impact a previously announced
advisory committee meeting cannot
always be published quickly enough to
provide timely notice. Therefore, you
should always check the agency’s Web
site and call the appropriate advisory
committee hot line/phone line to learn
about possible modifications before
coming to the meeting.
Agenda: The committee will discuss
biologics license application (BLA) No.
125277, KALBITOR, for ecallantide
injection by Dyax Corp., for the
proposed indication of treatment of
acute attacks of hereditary angioedema.
FDA intends to make background
material available to the public no later
than 2 business days before the meeting.
If FDA is unable to post the background
material on its Web site prior to the
meeting, the background material will
be made publicly available at the
location of the advisory committee
meeting, and the background material
will be posted on FDA’s Web site after
the meeting. Background material is
available at https://www.fda.gov/ohrms/
dockets/ac/acmenu.htm, click on the
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[Federal Register Volume 74, Number 9 (Wednesday, January 14, 2009)]
[Notices]
[Pages 2080-2081]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-574]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2008-N-0653]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Filing Objections and Requests for a Hearing on a
Regulation or Order
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 requirements for filing
objections and requests for a hearing on a regulation or order.
DATES: Submit written or electronic comments on the collection of
information by March 16, 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
[[Page 2081]]
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.
Filing Objections and Requests for a Hearing on a Regulation or Order--
21 CFR Part 12 (OMB Control Number 0910-0184)--Extension
The regulations in 21 CFR 12.22, issued under section 701(e)(2) of
the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C.
371(e)(2)), set forth the instructions for filing objections and
requests for a hearing on a regulation or order under Sec. 12.20(d)
(21CFR 12.20(d)). Objections and requests must be submitted within the
time specified in Sec. 12.20(e). Each objection, for which a hearing
has been requested, must be separately numbered and specify the
provision of the regulation or the proposed order. In addition, each
objection must include a detailed description and analysis of the
factual information and any other document, with some exceptions,
supporting the objection. Failure to include this information
constitutes a waiver of the right to a hearing on that objection. FDA
uses the description and analysis to determine whether a hearing
request is justified. The description and analysis may be used only for
the purpose of determining whether a hearing has been justified under
21 CFR 12.24 and do not limit the evidence that may be presented if a
hearing is granted.
Respondents to this information collection are those parties that
may be adversely affected by an order or regulation.
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
----------------------------------------------------------------------------------------------------------------
12.22 5 1 5 20 100
----------------------------------------------------------------------------------------------------------------
\1\There are no capital costs or operating and maintenance costs associated with this collection of information.
The burden estimate for this collection of information is based on
past filings. Agency personnel, responsible for processing the filing
of objections and requests for a public hearing on a specific
regulation or order, estimate approximately five requests are received
by the agency annually, with each requiring approximately 20 hours of
preparation time.
Please note that on January 15, 2008, the FDA Division of Dockets
Management Web site transitioned to the Federal Dockets Management
System (FDMS). FDMS is a Government-wide, electronic docket management
system. Electronic comments or submissions will be accepted by FDA only
through FDMS at https://www.regulations.gov.
Dated: January 7, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E9-574 Filed 1-13-09; 8:45 am]
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