Agency Information Collection Activities; Proposed Collection; Comment Request, 17217-17218 [2013-06382]
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Federal Register / Vol. 78, No. 54 / Wednesday, March 20, 2013 / Notices
K. Distribution Records
Sections 212.20(c) and 212.90(a)
require that written procedures
regarding distribution of PET drug
products be established and maintained.
We estimate that it will take
approximately 1 hour annually to
establish and maintain records of these
procedures for each PET production
facility. Section 212.90(b) requires that
distribution records be maintained. We
estimate that it will take approximately
15 minutes to create an actual
distribution record for each batch of
PET drug products, with a total burden
of approximately 16,157 hours for all
PET producers.
L. Complaints
Sections 212.20(c) and 212.100
require that PET drug producers
establish written procedures for dealing
with complaints, as well as document
how each complaint is handled. We
estimate that establishing and
maintaining written procedures for
complaints will take approximately 1
hour annually for each PET production
facility and that each facility will
receive approximately one complaint a
year and will spend approximately 30
minutes recording how the complaint
was dealt with.
TABLE 1—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Number of
recordkeepers
21 CFR Section
Number of
records per
recordkeeper
Total annual
records
212.20(c) and (e); 212.50(a) and (b) .....................................
212.20(d) and (e); 212.50(c); 212.80(c) .................................
129
129
1.71
501
221
64,629
212.20(c); 212.30(b); 212.50(d), 212.60(f) .............................
212.30(b); 212.50(d); 212.60(f) ..............................................
129
129
15
3,758
1,935
484,782
212.20(c); 212.40(a) and (b) ..................................................
212.40(e) ................................................................................
129
129
2
36
258
4,644
212.20(c); 212.60(a) and (b); 212.61(a); 212.70(a), (b), and
(d).
212.60(g); 212.61(b); 212.70(d)(2) and (d)(3) .......................
129
25
3,225
129
501
64,629
212.70(f) .................................................................................
212.20(c); 212.71(a) ...............................................................
212.71(b) ................................................................................
212.20(c); 212.71(d) ...............................................................
212.20(c); 212.90(a) ...............................................................
212.90(b) ................................................................................
129
129
129
129
129
129
1
36
1
1
1
501
129
4,644
129
129
129
64,629
212.20(c); 212.100(a) .............................................................
212.100(b) and (c) ..................................................................
129
129
1
1
129
129
Total ................................................................................
........................
........................
........................
1 There
Average
burden per
recordkeeper
20 ................
.5 .................
(30 min.)
1 ..................
.08 ...............
(5 min.)
1 ..................
.166 .............
(10 min.)
1 ..................
Total hours
4,420
32,315
1,935
40,237
258
771
3,225
.16 ...............
(10 min.)
1 ..................
1 ..................
1 ..................
1 ..................
1 ..................
.25 ...............
(15 min.)
1 ..................
.5 .................
(30 min.)
10,728
.....................
115,400
129
4,644
129
129
129
16,157
129
65
are no capital costs or operating and maintenance costs associated with this collection of information.
TABLE 2—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1
21 CFR Section
Number of
respondents
Annual
frequency of
disclosure
Total
annual
disclosures
Hours per
disclosure
Total hours
212.70(e) ..............................................................................
129
.25
32
1
32
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: March 14, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013–06351 Filed 3–19–13; 8:45 am]
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
srobinson on DSK4SPTVN1PROD with NOTICES
BILLING CODE 4160–01–P
Agency Information Collection
Activities; Proposed Collection;
Comment Request
ACTION:
Notice.
SUMMARY: In compliance with the
requirement for opportunity for public
comment on proposed data collection
projects (Section 3506(c)(2)(A) of Title
44, United States Code, as amended by
VerDate Mar<14>2013
18:04 Mar 19, 2013
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the Paperwork Reduction Act of 1995,
Pub. L. 104–13), the Health Resources
and Services Administration (HRSA)
publishes periodic summaries of
proposed projects being developed for
submission to the Office of Management
and Budget (OMB) under the Paperwork
Reduction Act of 1995. To request more
information on the proposed project or
to obtain a copy of the data collection
plans and draft instruments, email
paperwork@hrsa.gov or call the HRSA
Reports Clearance Officer at (301) 443–
1984.
HRSA especially requests comments
on: (1) The necessity and utility of the
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17218
Federal Register / Vol. 78, No. 54 / Wednesday, March 20, 2013 / Notices
proposed information collection for the
proper performance of the agency’s
functions, (2) the accuracy of the
estimated burden, (3) ways to enhance
the quality, utility, and clarity of the
information to be collected, and (4) the
use of automated collection techniques
or other forms of information
technology to minimize the information
collection burden.
Information Collection Request Title:
HRSA AIDS Education and Training
Centers Evaluation Activities: (OMB
No. 0915–0281)—Revision
Abstract: The AIDS Education and
Training Centers (AETC) Program,
under the Ryan White HIV/AIDS
Program established by Title XXVI of
the Public Health Service (PHS) Act, as
amended, supports a network of
regional and national centers that
conduct targeted, multi-disciplinary
education and training programs for
health care providers treating persons
with HIV/AIDS. The AETCs’ purpose is
to increase the number of health care
providers who are effectively educated
and motivated to counsel, diagnose,
treat, and medically manage individuals
with HIV infection, and to help prevent
high risk behaviors that lead to HIV
transmission.
As part of an ongoing effort to
evaluate AETC activities, information is
needed on AETC training sessions,
consultations, and technical assistance
activities. Each regional center collects
information on AETC training events,
and is required to report aggregate data
on their activities to HRSA’s HIV/AIDS
Bureau (HAB). The data provides
information on the number of training
events, including clinical trainings and
consultations, as well as technical
assistance activities conducted by each
regional center, the number of health
care providers receiving professional
training or consultation, and the time
and effort expended on different levels
of training and consultation activities.
In addition, information is obtained on
the populations served by AETC
trainees, and the increase in capacity
achieved through training events.
Collection of this information allows
HRSA’s HAB to provide information on
training activities and types of
education and training provided to Ryan
White HIV/AIDS Program Grantees,
Number of
respondents
Form
Responses per
respondent
resource allocation, and capacity
expansion. Trainees are asked to
complete the Participant Information
Form (PIF) for each activity they
complete, and trainers are asked to
complete the Event Record (ER).
Burden Statement: Burden in this
context means the time expended by
persons to generate, maintain, retain,
disclose or provide the information
requested. This includes the time
needed to review instructions, to
develop, acquire, install and utilize
technology and systems for the purpose
of collecting, validating and verifying
information, processing and
maintaining information, and disclosing
and providing information, to train
personnel and to be able to respond to
a collection of information, to search
data sources, to complete and review
the collection of information, and to
transmit or otherwise disclose the
information. The total annual burden
hours estimated for this Information
Collection Request are summarized in
the table below.
The annual estimate of burden is as
follows:
Total responses
Average burden
per response
(in hours)
Total burden
hours
PIF ..................................................................
ER ..................................................................
116,624
18,070
1
1
116,624
18,070
0.167
0.2
19,476.2
3,614.0
Total ........................................................
134,694
............................
134,694
..............................
23,090.2
Number of
respondents
Responses per
respondent
Total responses
Hours per
response
Total burden
hours
16
2
32
32
1024.0
The estimated annual burden to
AETCs is as follows:
Aggregate Data Set .........................................
The total burden hours are 24,114.2.
Submit your comments to
paperwork@hrsa.gov or mail to the
HRSA Reports Clearance Officer, Room
10–29, Parklawn Building, 5600 Fishers
Lane, Rockville, MD 20857.
Deadline: Comments on this
Information Collection Request must be
received within 60 days of this notice.
srobinson on DSK4SPTVN1PROD with NOTICES
ADDRESSES:
Dated: March 12, 2013.
Bahar Niakan,
Director, Division of Policy and Information
Coordination.
[FR Doc. 2013–06382 Filed 3–19–13; 8:45 am]
BILLING CODE 4165–15–P
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Allergy and
Infectious Diseases; Notice of Closed
Meeting
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
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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 of
Allergy and Infectious Diseases Special
Emphasis Panel, ‘‘Limited Competition:
Collaborative Partnership to Advance Global
Biomedical Research Programs (U01).’’
Date: April 12, 2013.
Time: 1:00 p.m. to 3:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6700B
Rockledge Drive, Bethesda, MD 20817,
(Telephone Conference Call).
Contact Person: Andrea L Wurster, Ph.D.,
Scientific Review Officer, Scientific Review
Program, DEA/NIAID/NIH/DHHS, Room
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]]>Agencies
[Federal Register Volume 78, Number 54 (Wednesday, March 20, 2013)]
[Notices]
[Pages 17217-17218]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-06382]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration
Agency Information Collection Activities; Proposed Collection;
Comment Request
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: In compliance with the requirement for opportunity for public
comment on proposed data collection projects (Section 3506(c)(2)(A) of
Title 44, United States Code, as amended by the Paperwork Reduction Act
of 1995, Pub. L. 104-13), the Health Resources and Services
Administration (HRSA) publishes periodic summaries of proposed projects
being developed for submission to the Office of Management and Budget
(OMB) under the Paperwork Reduction Act of 1995. To request more
information on the proposed project or to obtain a copy of the data
collection plans and draft instruments, email paperwork@hrsa.gov or
call the HRSA Reports Clearance Officer at (301) 443-1984.
HRSA especially requests comments on: (1) The necessity and utility
of the
[[Page 17218]]
proposed information collection for the proper performance of the
agency's functions, (2) the accuracy of the estimated burden, (3) ways
to enhance the quality, utility, and clarity of the information to be
collected, and (4) the use of automated collection techniques or other
forms of information technology to minimize the information collection
burden.
Information Collection Request Title: HRSA AIDS Education and Training
Centers Evaluation Activities: (OMB No. 0915-0281)--Revision
Abstract: The AIDS Education and Training Centers (AETC) Program,
under the Ryan White HIV/AIDS Program established by Title XXVI of the
Public Health Service (PHS) Act, as amended, supports a network of
regional and national centers that conduct targeted, multi-disciplinary
education and training programs for health care providers treating
persons with HIV/AIDS. The AETCs' purpose is to increase the number of
health care providers who are effectively educated and motivated to
counsel, diagnose, treat, and medically manage individuals with HIV
infection, and to help prevent high risk behaviors that lead to HIV
transmission.
As part of an ongoing effort to evaluate AETC activities,
information is needed on AETC training sessions, consultations, and
technical assistance activities. Each regional center collects
information on AETC training events, and is required to report
aggregate data on their activities to HRSA's HIV/AIDS Bureau (HAB). The
data provides information on the number of training events, including
clinical trainings and consultations, as well as technical assistance
activities conducted by each regional center, the number of health care
providers receiving professional training or consultation, and the time
and effort expended on different levels of training and consultation
activities. In addition, information is obtained on the populations
served by AETC trainees, and the increase in capacity achieved through
training events. Collection of this information allows HRSA's HAB to
provide information on training activities and types of education and
training provided to Ryan White HIV/AIDS Program Grantees, resource
allocation, and capacity expansion. Trainees are asked to complete the
Participant Information Form (PIF) for each activity they complete, and
trainers are asked to complete the Event Record (ER).
Burden Statement: Burden in this context means the time expended by
persons to generate, maintain, retain, disclose or provide the
information requested. This includes the time needed to review
instructions, to develop, acquire, install and utilize technology and
systems for the purpose of collecting, validating and verifying
information, processing and maintaining information, and disclosing and
providing information, to train personnel and to be able to respond to
a collection of information, to search data sources, to complete and
review the collection of information, and to transmit or otherwise
disclose the information. The total annual burden hours estimated for
this Information Collection Request are summarized in the table below.
The annual estimate of burden is as follows:
--------------------------------------------------------------------------------------------------------------------------------------------------------
Average burden
Form Number of Responses per Total responses per response (in Total burden
respondents respondent hours) hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
PIF.......................................................... 116,624 1 116,624 0.167 19,476.2
ER........................................................... 18,070 1 18,070 0.2 3,614.0
------------------------------------------------------------------------------------------
Total.................................................... 134,694 ................ 134,694 ................. 23,090.2
--------------------------------------------------------------------------------------------------------------------------------------------------------
The estimated annual burden to AETCs is as follows:
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of Responses per Hours per Total burden
respondents respondent Total responses response hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
Aggregate Data Set....................................... 16 2 32 32 1024.0
--------------------------------------------------------------------------------------------------------------------------------------------------------
The total burden hours are 24,114.2.
ADDRESSES: Submit your comments to paperwork@hrsa.gov or mail to the
HRSA Reports Clearance Officer, Room 10-29, Parklawn Building, 5600
Fishers Lane, Rockville, MD 20857.
Deadline: Comments on this Information Collection Request must be
received within 60 days of this notice.
Dated: March 12, 2013.
Bahar Niakan,
Director, Division of Policy and Information Coordination.
[FR Doc. 2013-06382 Filed 3-19-13; 8:45 am]
BILLING CODE 4165-15-P
