Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Filing Objections and Requests for a Hearing on a Regulation or Order, 15295-15296 [E9-7472]
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15295
Federal Register / Vol. 74, No. 63 / Friday, April 3, 2009 / Notices
(2) Specialists. This cohort includes
office-based practitioners in
rheumatology with at least 3 years of
experience and who engage in patient
care at least 50 percent of the time.
Cohorts will be identified and
recruited to represent a reasonable range
of age, gender, and ethnicity.
Within each cohort, 20 practitioners
will be interviewed by trained
interviewers in one-on-one in-depth
telephone interviews. A sample size of
40 (approximately 20 primary care
providers and 20 rheumatologists) is
sufficiently large for the qualitative
findings to capture a wide depth and
range of people’s thinking. The
interviews will take approximately 45
minutes. The health care provider
interviews will be used to create a
mental model of physician
decisionmaking factors with respect to
drug product effectiveness.
Potential physician participants will
be randomly identified through a
purchased list based on the American
Medical Association’s (AMA) Physician
Masterfile. This list tracks all
physicians, M.D. (doctor of medicine)
and DO (doctor of osteopathic
medicine), practicing in the United
States, not only members of the AMA.
FDA intends this collection to be used
as formative research. As with our focus
group research (OMB control number
0910–0360), the results of this formative
research will provide direction toward
potential areas of focus. Further
research is necessary, and planned, to
test concepts obtained from these
results. This research will be useful in
designing survey questions for the next
phases of this research project (which
will be submitted for approval at a later
date).
In the Federal Register of November
24, 2008 (73 FR 71006), FDA published
a 60-day notice requesting public
comment on the information collection
provisions. No comments were received.
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN1
No. of
Respondents
21 CFR Section
Annual Frequency
per Response
Total Annual
Responses
Hours Per
Response
Total Hours
21 U.S.C. 393(b)(2)(c) Questionnaire, Pretesting
4
1
4
.75
3
21 U.S.C. 393(b)(2)(c) Questionnaire, Study
40
1
40
.75
30
Total
33
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: March 27, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and
Planning.
[FR Doc. E9–7471 Filed 4–2–09; 8:45 am]
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 0910–0184. Also
include the FDA docket number found
in brackets in the heading of this
document.
ADDRESSES:
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2008–N–0653]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Filing Objections
and Requests for a Hearing on a
Regulation or Order
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
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 May 4,
2009.
sroberts on PROD1PC70 with NOTICES
SUMMARY:
VerDate Nov<24>2008
16:07 Apr 02, 2009
Jkt 217001
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.
Filing Objections and Requests for a
Hearing on a Regulation or Order—
(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
PO 00000
Frm 00056
Fmt 4703
Sfmt 4703
order under § 12.20(d) (21 CFR
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.
In the Federal Register of January 14,
2009 (74 FR 2080), FDA published a 60day notice requesting public comment
on the information collection
provisions. No comments were received.
FDA estimates the burden of this
collection of information as follows:
E:\FR\FM\03APN1.SGM
03APN1
15296
Federal Register / Vol. 74, No. 63 / Friday, April 3, 2009 / Notices
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN1
No. of
Respondents
21 CFR Section
12.22
1There
Annual Frequency
per Response
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.
2009, 5 p.m., National Institutes of
Health, Two Democracy Plaza, 6707
Democracy Boulevard, Bethesda, MD
20892 which was published in the
Federal Register on February 17, 2009,
74 FR 7452.
This meeting is being amended to
reschedule the meeting to April 13–14,
2009 from 8 a.m. to 5 p.m. The meeting
is closed to the public.
Dated: March 27, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and
Planning.
[FR Doc. E9–7472 Filed 4–2–09; 8:45 am]
Dated: March 24, 2009.
Jennifer Spaeth,
Director, Office of Federal Advisory
Committee Policy.
[FR Doc. E9–7263 Filed 4–2–09; 8:45 am]
BILLING CODE 4160–01–S
Career Development Awards for Scientists
and Clinicians; 93.272, Alcohol National
Research Service Awards for Research
Training; 93.273, Alcohol Research Programs;
93.891, Alcohol Research Center Grants,
National Institutes of Health, HHS)
BILLING CODE 4140–01–M
Dated: March 25, 2009.
Jennifer Spaeth,
Director, Office of Federal Advisory
Committee Policy.
[FR Doc. E9–7319 Filed 4–2–09; 8:45 am]
BILLING CODE 4140–01–M
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institutes of Health
National Cancer Institute; Amended
Notice of Meeting
National Institute on Alcohol Abuse
and Alcoholism; Notice of Closed
Meeting
Notice is hereby given of a change in
the meeting of the President’s Cancer
Panel, March 23, 2009, 12:30 p.m. to
March 23, 2009, 3 p.m., National
Institutes of Health, 6116 Executive
Boulevard, Rockville, MD 20852 which
was published in the Federal Register
on March 19, 2009, 74 FR 11741.
This meeting is being amended to
reschedule the meeting to Tuesday,
March 31, 2009, 10 a.m. to 12:30 p.m.
as a telephone conference. The meeting
is closed to the public.
Dated: March 25, 2009.
Jennifer Spaeth,
Director, Office of Federal Advisory
Committee Policy.
[FR Doc. E9–7318 Filed 4–2–09; 8:45 am]
BILLING CODE 4140–01–M
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
sroberts on PROD1PC70 with NOTICES
National Institutes of Health
National Center for Complementary &
Alternative Medicine; Amended Notice
of Meeting
Notice is hereby given of a change in
the meeting of the National Center for
Complementary and Alternative
Medicine Special Emphasis Panel,
March 24, 2009, 8 a.m. to March 25,
VerDate Nov<24>2008
16:07 Apr 02, 2009
Jkt 217001
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of the following meeting.
The meeting will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Institute on
Alcohol Abuse and Alcoholism, Special
Emphasis Panel. AA3 Deferred Applications.
Date: April 22, 2009.
Time: 2 p.m. to 4 p.m.
Agenda: To review and evaluate grant
applications.
Place: NIH/NIAAA, 5635 Fishers Lane,
Bethesda, MD 20892 (Telephone Conference
Call).
Contact Person: Katrina L Foster, PhD,
Scientific Review Officer, National Inst on
Alcohol Abuse & Alcoholism, National
Institutes of Health, 5635 Fishers Lane, Rm.
2019, Rockville, MD 20852, 301–443–4032.
katrina@mail.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.271, Alcohol Research
PO 00000
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Notice of a Conference Call of a
Working Group of the NIH Blue Ribbon
Panel
The purpose of this notice is to inform
the public about a conference call of the
NIH Blue Ribbon Panel to Advise on the
Risk Assessment of the National
Emerging Infectious Diseases
Laboratories at Boston University
Medical Center. This meeting is the first
in a series of public meetings to review
and discuss the ongoing supplementary
risk assessment study.
The conference call will be held on
Tuesday, April 7, 2009 from
approximately 11 a.m. to 1 p.m. The
toll-free number to participate in the
call is 1–800–779–2616. Indicate to the
conference operator that your
participant passcode is ‘‘NIH.’’
The panel will review earlier National
Research Council (NRC)
recommendations regarding a
supplementary risk assessment study,
Blue Ribbon Panel recommendations
regarding various aspects of the risk
assessment study, and a new Statement
of Task for the NRC.
Public comment will begin at
approximately 12:45 p.m. In the event
that time does not allow for all those
interested to present oral comments,
anyone may file written comments by
sending them to the address below.
Comments should include the name,
address, telephone number and when
applicable, the business or professional
affiliation of the commenter.
A draft agenda and slides for the
meeting may be obtained by connecting
to https://nihblueribbonpanel-bumc-
E:\FR\FM\03APN1.SGM
03APN1
Agencies
[Federal Register Volume 74, Number 63 (Friday, April 3, 2009)]
[Notices]
[Pages 15295-15296]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-7472]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2008-N-0653]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; 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 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 May 4,
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 0910-0184.
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.
Filing Objections and Requests for a Hearing on a Regulation or Order--
(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)
(21 CFR 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.
In the Federal Register of January 14, 2009 (74 FR 2080), 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:
[[Page 15296]]
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.
Dated: March 27, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E9-7472 Filed 4-2-09; 8:45 am]
BILLING CODE 4160-01-S