Statement of Delegation of Authority, 13646-13647 [2011-5808]
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Federal Register / Vol. 76, No. 49 / Monday, March 14, 2011 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–N–0002]
Vaccines and Related Biological
Products Advisory Committee; Notice
of Meeting
AGENCY:
Food and Drug Administration,
HHS.
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ACTION:
Notice.
This notice announces a forthcoming
meeting of a public advisory committee
of the Food and Drug Administration
(FDA). At least one portion of the
meeting will be closed to the public.
Name of Committee: Vaccines and
Related Biological Products 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 April 6, 2011, between
approximately 9 a.m. and 4 p.m. and on
April 7, 2011, between approximately
8:30 a.m. and 3:30 p.m.
Location: Hilton Hotel, Washington
DC North/Gaithersburg, 620 Perry
Pkwy., Gaithersburg, MD 20877.
Contact Person: Donald W. Jehn or
Denise Royster, Center for Biologics
Evaluation and Research (HFM–71),
Food and Drug Administration, 1401
Rockville Pike, Rockville, MD 20852,
301–827–0314, or FDA Advisory
Committee Information Line, 1–800–
741–8138 (301–443–0572 in the
Washington, DC area), and follow the
prompts to the desired center or product
area. 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: On the morning of April 6,
2011, the committee will meet in open
session to hear updates of the research
programs in the Laboratory of Bacterial
Polysaccharides, Division of Bacterial,
Parasitic, and Allergenic Products,
Office of Vaccines Research and Review,
Center for Biologics Evaluation and
Research, FDA. In the afternoon of April
6, 2011, the committee will meet in
open session and will be briefed on the
use of immunological markers for
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demonstration of effectiveness of
meningococcal serogroups A, C, Y, and
W–135 conjugate vaccines administered
to children less than 2 years of age. On
April 7, 2011, the committee will meet
in open session to review and discuss
approaches to licensure of
meningococcal serogroup B vaccines.
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/
AdvisoryCommittees/Calendar/
default.htm. Scroll down to the
appropriate advisory committee link.
Procedure: On April 6, 2011, from
approximately 9 a.m to 10:50 a.m. and
from approximately 12:30 p.m to 4 p.m.,
the meeting is open to the public. On
April 7, 2011, the entire meeting is open
to the public. Interested persons may
present data, information, or views,
orally or in writing, on issues pending
before the committee. Written
submissions may be made to the contact
person on or before March 30, 2011.
Oral presentations from the public will
be scheduled between approximately
10:20 a.m. and 10:50 a.m. and between
approximately 2:30 p.m. and 3 p.m. on
April 6, 2011, and between
approximately 1:30 p.m. and 2 p.m. on
April 7, 2011. Those individuals
interested in making formal oral
presentations should notify the contact
person and submit a brief statement of
the general nature of the evidence or
arguments they wish to present, the
names and addresses of proposed
participants, and an indication of the
approximate time requested to make
their presentation on or before March
22, 2011. Time allotted for each
presentation may be limited. If the
number of registrants requesting to
speak is greater than can be reasonably
accommodated during the scheduled
open public hearing session, FDA may
conduct a lottery to determine the
speakers for the scheduled open public
hearing session. The contact person will
notify interested persons regarding their
request to speak by March 23, 2011.
Closed Committee Deliberations: On
April 6, 2011, between approximately
10:50 a.m. and 11:30 a.m., the meeting
will be closed to permit discussion
where disclosure would constitute a
clearly unwarranted invasion of
personal privacy (5 U.S.C. 552b(c)(6)).
The committee will discuss the report of
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the intramural research programs and
make recommendations regarding
personnel staffing decisions.
Persons attending FDA’s advisory
committee meetings are advised that the
Agency is not responsible for providing
access to electrical outlets.
FDA welcomes the attendance of the
public at its advisory committee
meetings and will make every effort to
accommodate persons with physical
disabilities or special needs. If you
require special accommodations due to
a disability, please contact Donald W.
Jehn or Denise Royster at least 7 days in
advance of the meeting.
FDA is committed to the orderly
conduct of its advisory committee
meetings. Please visit our Web site at
https://www.fda.gov/
AdvisoryCommittees/
AboutAdvisoryCommittees/
ucm111462.htm for procedures on
public conduct during advisory
committee meetings.
Notice of this meeting is given under
the Federal Advisory Committee Act (5
U.S.C. app. 2).
Dated: March 4, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011–5727 Filed 3–11–11; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Statement of Delegation of Authority
Notice is hereby given that I have
delegated to the Administrator, Health
Resources and Services Administration
(HRSA), authority vested in the
Secretary under Title XX, Section
2008(b) of the Social Security Act (42
U.S.C. 1397g(b)), as added by Section
5507(a) of the Affordable Care Act, as it
pertains to the functions assigned to
HRSA. This authority may be
redelegated.
HRSA will consult with the Assistant
Secretary for Planning and Evaluation,
as appropriate, in implementing this
authority.
This delegation excludes the authority
to issue regulations, to establish
advisory councils and committees and
appoint their members, and to submit
reports to Congress, and shall be
exercised in accordance with the
Department’s applicable policies,
procedures, and guidelines. In addition,
I hereby affirm and ratify any actions
taken by the Administrator, HRSA, or
other HRSA officials, which involved
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13647
Federal Register / Vol. 76, No. 49 / Monday, March 14, 2011 / Notices
the exercise of this authority prior to the
effective date of this delegation.
This delegation is effective upon date
of signature.
Dated: March 4, 2011.
Kathleen Sebelius,
Secretary.
[FR Doc. 2011–5808 Filed 3–11–11; 8:45 am]
BILLING CODE 4165–15–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Proposed Collection; Comment
Request—Interactive Diet and Activity
Tracking in AARP (iDATA): Biomarker
Based Validation Study
Summary: In compliance with the
requirement of Section 3506(c)(2)(A) of
the Paperwork Reduction Act of 1995,
for opportunity for public comment on
proposed data collection projects, the
National Cancer Institute (NCI), the
National Institutes of Health (NIH) will
publish periodic summaries of proposed
projects to be submitted to the Office of
Management and Budget (OMB) for
review and approval.
Proposed Collection: Title: Interactive
Diet and Activity Tracking in AARP
(iDATA): Biomarker Based Validation
Study.
Type of Information Collection
Request: New.
Need and Use of Information
Collection: The AARP-based study is
one component of a multi-center
biomarker validation study project
involving two other large cohorts in the
United States. The iDATA study
involves large cohorts and provides the
necessary sample size to evaluate the
measurement error structure of the diet
and physical activity assessment
instruments and the heterogeneity of the
measurement error structure across
multiple and diverse study populations.
The iDATA study will include 1,500
participants from the NIH–AARP Diet
and Health Study and current AARP
membership. The data collection
instruments adhere to The Public Health
Service Act, which provides authority to
the Risk Factor Monitoring and Methods
Branch in the Division of Cancer
Control and Population Sciences and
the Division of Cancer Epidemiology
and Genetics. Both divisions work to
reduce cancer in the U.S. population by
establishing and supporting programs
for the detection, diagnosis, prevention
and treatment of cancer; and by
collecting, identifying, analyzing and
disseminating information on cancer
research, diagnosis, prevention and
treatment. Dietary and physical activity
data will be gathered using the
instruments as detailed below. In
addition, biospecimen and clinic data
will be also gathered.
Frequency of Response: Monthly.
Affected Public: Individuals.
Type of Respondents: U.S. adults
(persons aged 50–74).
The annual reporting burden is
provided for each study component as
shown in the table below. There are no
Capital Costs, Operating Costs, and/or
Maintenance Costs to report.
TABLE 1 ESTIMATES OF ANNUAL BURDEN HOURS
[Type of respondents for all instruments: Adult participants, 50–74 years of age]
Number of
respondents
Frequency
of response
Average time
per response
(minutes/hour)
Annual burden hours
Pre-Screening Telephone Interview (Attachment 1) ...
Clinic Eligibility Screening Interview (Attachment 3) ...
NHANES III Anthropometry (Attachment 13) ..............
Resting Metabolic Rate—Main (Attachment 7) ...........
Resting Metabolic Rate—Subsample (Attachment 7)
Fasting Blood Protocol and Form (Attachment 5) ......
Fitness test Protocol and Form (Attachment 10) ........
Physical Activity Readiness Questionnaires—PAR–Q
or PARmed-X (Attachments 11A–11B).
Doubly Labelled Water—Main (Attachment 6) ............
Doubly Labelled Water—Subsample (Attachment 6)
Automated Self-Administered 24-hour Dietary Recall
(ASA24) (Attachment 32).
4-Day Food Record (Attachment 17) ..........................
Diet History Questionnaire (DHQ*Web-II) (Attachment
33).
7-Day Food Checklist (Attachment 16) .......................
Activities Completed over Time in 24 Hours (ACT24)
(Attachment 34).
Community Healthy Activities Model Program for
Seniors (CHAMPS) (Attachment 19).
Harvard Lifestyle Validation Study Physical Activity
Questionnaire (Attachment 18).
Sedentary Behaviors Questionnaire (Attachment 21)
Stanford physical activity Survey (Attachment 22) .....
NIH–AARP physical activity questions (Attachment
20).
24 Hour Urine Collection Log (Attachment 14) ...........
Saliva Protocol and Form (Attachment 15) .................
Heart Rate Monitor Log (Attachment 8) ......................
Physical Activity Monitor Log (Accelerometer/Inclinometer) (Attachment 12).
1,334
742
742
742
34
742
742
742
1
1
3
1
1
2
1
1
15/60 (.25)
10/60 (.167)
10/60 (.167)
30/60 (.50)
30/60 (.50)
10/60 (.167)
15/60 (.25)
5/60 (.083)
334
124
371
371
17
247
186
62
742
34
742
1
1
6
40/60 (.667)
40/60 (.667)
30/60 (.50)
495
23
2,227
742
742
2
2
60/60 (1.0)
45/60 (.75)
1,485
1,114
742
742
2
6
60/60 (1.0)
30/60 (.50)
1,485
2,227
742
2
15/60 (.25)
371
742
2
10/60 (.167)
247
742
742
742
2
2
2
20/60 (.33)
8/60 (.133)
10/60 (.167)
495
198
247
742
742
34
742
2
3
1
2
60/60 (1.0)
10/60 (.167)
35/60 (.583)
35/60 (.583)
1,485
371
20
866
......................................................................................
....................
....................
........................
15,060
Study component
Instrument
Screening ...........................
Clinical Components ..........
Dietary Questionnaires ......
Physical Activity Questionnaires.
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Home Collections ..............
Total ............................
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]]>Agencies
[Federal Register Volume 76, Number 49 (Monday, March 14, 2011)]
[Notices]
[Pages 13646-13647]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-5808]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration
Statement of Delegation of Authority
Notice is hereby given that I have delegated to the Administrator,
Health Resources and Services Administration (HRSA), authority vested
in the Secretary under Title XX, Section 2008(b) of the Social Security
Act (42 U.S.C. 1397g(b)), as added by Section 5507(a) of the Affordable
Care Act, as it pertains to the functions assigned to HRSA. This
authority may be redelegated.
HRSA will consult with the Assistant Secretary for Planning and
Evaluation, as appropriate, in implementing this authority.
This delegation excludes the authority to issue regulations, to
establish advisory councils and committees and appoint their members,
and to submit reports to Congress, and shall be exercised in accordance
with the Department's applicable policies, procedures, and guidelines.
In addition, I hereby affirm and ratify any actions taken by the
Administrator, HRSA, or other HRSA officials, which involved
[[Page 13647]]
the exercise of this authority prior to the effective date of this
delegation.
This delegation is effective upon date of signature.
Dated: March 4, 2011.
Kathleen Sebelius,
Secretary.
[FR Doc. 2011-5808 Filed 3-11-11; 8:45 am]
BILLING CODE 4165-15-P
