Submission for OMB Review; Comment Request, 14808-14809 [2012-5951]
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Federal Register / Vol. 77, No. 49 / Tuesday, March 13, 2012 / Notices
valid authorization. In order to be valid,
an authorization must include specified
core elements and statements. CMS will
make available to PCIP applicants and
enrollees a standard, valid authorization
to enable beneficiaries to request the
disclosure of their protected health
information. CMS will make available to
PCIP applicants and enrollees a
standard, valid authorization to enable
beneficiaries to communicate with PCIP
about their personal health information.
This is a critical tool because the
population the PCIP program serves is
comprised of individuals with preexisting conditions who may be
incapacitated and need an advocate to
help them apply for or receive benefits
from the program. This standard
authorization will simplify the process
of requesting information disclosure for
beneficiaries and minimize the response
time for the PCIP program; Form
Number: CMS–10428 (OMB 0938–New);
Frequency: Occasionally; Affected
Public: Private Sector (Business or other
for-profit and Not-for-profit
institutions); Number of Respondents:
2,100; Total Annual Responses: 2,100;
Total Annual Hours: 525. (For policy
questions regarding this collection
contact Laura Dash at 410–786–8623.
For all other issues call 410–786–1326.)
CMS is requesting OMB review and
approval of this collection by March 22,
2012. To be assured consideration,
comments and recommendations for the
proposed information collections must
be received by via one of the methods
below on March 19, 2012.
To obtain copies of the supporting
statement and any related forms for the
proposed paperwork collections
referenced above, access CMS’ Web Site
address at https://www.cms.gov/
PaperworkReductionActof1995/PRAL/
list.asp or Email your request, including
your address, phone number, OMB
number, and CMS document identifier,
to Paperwork@cms.hhs.gov, or call the
Reports Clearance Office on (410) 786–
1326.
Interested persons are invited to send
comments regarding the burden or any
other aspect of these collections of
information requirements. However, as
noted above, comments on these
information collection and
recordkeeping requirements must be
received via one of the following
methods by March 19, 2012.
1. Electronically. You may submit
your comments electronically to https://
www.regulations.gov. Follow the
instructions for ‘‘Comment or
Submission’’ or ‘‘More Search Options’’
to find the information collection
document(s) accepting comments.
2. By regular mail. You may mail
written comments to the following
address: CMS, Office of Strategic
Operations and Regulatory Affairs,
Division of Regulations Development,
Attention: Document Identifier CMS–
10417, Room C4–26–05, 7500 Security
Boulevard, Baltimore, Maryland 21244–
1850.
3. By Email to OMB. OMB, Office of
Information and Regulatory Affairs,
Attention: CMS Desk Officer, Email:
OIRA_submission@omb.eop.gov.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
Submission for OMB Review;
Comment Request
Title: Descriptive Study of Tribal
Temporary Assistance for Needy
Families (TANF) Programs—Interview
Guides.
OMB No.: New Collection.
Description: The Administration for
Children and Families (ACF) is
proposing an information collection
activity as part of the Descriptive Study
of Tribal TANF Programs. The proposed
information collection consists of semistructured interviews and focus groups
with key Tribal TANF respondents on
questions of Tribal TANF
administration, policies, service
delivery, and program context. Through
this information collection, ACF seeks
to gain an in-depth, systematic
understanding of program
implementation, operations, outputs
and outcomes in selected sites, and
identify promising practices and other
areas for further study.
Respondents: Semi-structured
interviews will be held with Tribal
TANF administrators and staff, and staff
of related programs. Focus groups will
be held with Tribal TANF clients.
Dated: March 8, 2012.
Martique Jones,
Director, Regulations Development Group,
Division B, Office of Strategic Operations and
Regulatory Affairs.
Annual Burden Estimates
Please note that the burden rates
below are revised since the 60 day
Federal Register Notice to reflect lower
burden hours.
[FR Doc. 2012–6035 Filed 3–12–12; 8:45 am]
BILLING CODE 4120–01–P
TABLE 1—ANNUAL BURDEN ESTIMATES
Annual
number of
respondents
Instrument
Number of
responses per
respondent
Average
burden hours
per response
Total annual
burden hours
4
1
1.5
6
Discussion Guide for use with tribal TANF Staff .............................................
12
1
1
12
Discussion Guide for use with Focus Groups with tribal TANF clients ..........
20
1
2
40
Discussion guide for use with staff of related programs .................................
20
1
1
20
All instruments: .........................................................................................
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Discussion Guide for use with tribal TANF Administrators .............................
........................
........................
........................
78
Additional Information
Copies of the proposed collection may
be obtained by writing to the
Administration for Children and
Families, Office of Planning, Research,
and Evaluation, 370 L’Enfant
Promenade, SW., Washington, DC
VerDate Mar<15>2010
18:29 Mar 12, 2012
Jkt 226001
20447, Attn: OPRE Reports Clearance
Officer. All requests should be
identified by the title of the information
collection. Email address:
OPREinfocollection@acf.hhs.gov. OMB
Comment: OMB is required to make a
decision concerning the collection of
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information between 30 and 60 days
after publication of this document in the
Federal Register. Therefore, a comment
is best assured of having its full effect
if OMB receives it within 30 days of
publication. Written comments and
recommendations for the proposed
E:\FR\FM\13MRN1.SGM
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Federal Register / Vol. 77, No. 49 / Tuesday, March 13, 2012 / Notices
information collection should be sent
directly to the following: Office of
Management and Budget, Paperwork
Reduction Project, Fax: 202–395–6974,
Attn: Desk Officer for the
Administration for Children and
Families.
Dated: March 7, 2012.
Steven M. Hanmer,
Reports Clearance, Officer; Office of Planning,
Research and Evaluation.
[FR Doc. 2012–5951 Filed 3–12–12; 8:45 am]
BILLING CODE 4184–37–M
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2012–N–0194]
Agency Information Collection
Activities: Proposed Collection;
Comment Request; Biosimilars User
Fee Cover Sheet; Form FDA 3792
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
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, and to allow 60 days for
public comment in response to the
notice. This notice solicits comments
concerning Form FDA 3792, entitled
‘‘Biosimilars User Fee Cover Sheet.’’
DATES: Submit written or electronic
comments on the collection of
information by May 14, 2012.
ADDRESSES: Submit electronic
comments to https://
www.regulations.gov. Submit written
comments 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:
Juanmanuel Vilela, Office of
Information Management, Food and
Drug Administration, 1350 Piccard Dr.,
mstockstill on DSK4VPTVN1PROD with NOTICES
SUMMARY:
VerDate Mar<15>2010
18:29 Mar 12, 2012
Jkt 226001
PI50–400B, Rockville, MD 20850, 301–
796–7651,
Juanmanuel.vilela@fda.hhs.gov.
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
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: (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.
The March 23, 2010 Affordable Care
Act contains a subtitle called the
Biologics Price Competition and
Innovation Act of 2009 (BPCI Act) that
amends the Public Health Service Act
(PHS Act) and other statutes to create an
abbreviated approval pathway for
biological products shown to be
biosimilar to or interchangeable with an
FDA-licensed reference biological
product. Section 351(k) of the PHS Act,
added by the BPCI Act, allows a
company to submit an application for
licensure of a biosimilar or
interchangeable biological product. The
BPCI Act also amends section 735 of the
Federal Food, Drug, and Cosmetic Act
SUPPLEMENTARY INFORMATION:
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14809
(FD&C Act) to include 351(k)
applications in the definition of ‘‘human
drug application’’ for the purposes of
the prescription drug user fee
provisions. The authority conferred by
the FD&C Act’s prescription drug user
fee provisions expires in September,
2012. The BPCI Act directs FDA to
develop recommendations for a
biosimilar biological product user fee
program for fiscal years 2013 through
2017. FDA’s recommendations for a
biosimilar biological product user fee
program were submitted to Congress on
January 13, 2012. If enacted into law,
FDA’s proposed biosimilar biological
product user fee program would require
FDA to assess and collect user fees for
certain meetings concerning biosimilar
biological product development (BPD
meetings), investigational new drug
applications (INDs) intended to support
a biosimilar biological product
application, and biosimilar biological
product applications and supplements.
Proposed Form FDA 3792, the
Biosimilars User Fee Cover Sheet,
requests the minimum necessary
information to determine the amount of
the fee required, and to account for and
track user fees. The form would provide
a cross-reference of the fees submitted
for a submission with the actual
submission by using a unique number
tracking system. The information
collected would be used by FDA’s
Center for Drug Evaluation and Research
and Center for Biologics Evaluation and
Research to initiate the administrative
screening of biosimilar biological
product INDs, applications, and
supplements, and to account for and
track user fees associated with BPD
meetings.
Respondents to this proposed
collection of information would be
manufacturers of biosimilar biological
product candidates. Based on FDA’s
database system, there are an estimated
18 manufacturers that fall into this
category. However, not all
manufacturers will have submissions in
a given year and some may have
multiple submissions. FDA estimates
nine annual responses that include the
following: Six INDs or BPD meetings,
two applications, and one supplement.
The estimated hours per response are
based on FDA’s past experience with
other submissions, and average 30
minutes.
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]]>Agencies
[Federal Register Volume 77, Number 49 (Tuesday, March 13, 2012)]
[Notices]
[Pages 14808-14809]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-5951]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Administration for Children and Families
Submission for OMB Review; Comment Request
Title: Descriptive Study of Tribal Temporary Assistance for Needy
Families (TANF) Programs--Interview Guides.
OMB No.: New Collection.
Description: The Administration for Children and Families (ACF) is
proposing an information collection activity as part of the Descriptive
Study of Tribal TANF Programs. The proposed information collection
consists of semi-structured interviews and focus groups with key Tribal
TANF respondents on questions of Tribal TANF administration, policies,
service delivery, and program context. Through this information
collection, ACF seeks to gain an in-depth, systematic understanding of
program implementation, operations, outputs and outcomes in selected
sites, and identify promising practices and other areas for further
study.
Respondents: Semi-structured interviews will be held with Tribal
TANF administrators and staff, and staff of related programs. Focus
groups will be held with Tribal TANF clients.
Annual Burden Estimates
Please note that the burden rates below are revised since the 60
day Federal Register Notice to reflect lower burden hours.
Table 1--Annual Burden Estimates
----------------------------------------------------------------------------------------------------------------
Annual number Number of Average
Instrument of responses per burden hours Total annual
respondents respondent per response burden hours
----------------------------------------------------------------------------------------------------------------
Discussion Guide for use with tribal TANF 4 1 1.5 6
Administrators.................................
----------------------------------------------------------------------------------------------------------------
Discussion Guide for use with tribal TANF Staff. 12 1 1 12
----------------------------------------------------------------------------------------------------------------
Discussion Guide for use with Focus Groups with 20 1 2 40
tribal TANF clients............................
----------------------------------------------------------------------------------------------------------------
Discussion guide for use with staff of related 20 1 1 20
programs.......................................
---------------------------------------------------------------
All instruments:............................ .............. .............. .............. 78
----------------------------------------------------------------------------------------------------------------
Additional Information
Copies of the proposed collection may be obtained by writing to the
Administration for Children and Families, Office of Planning, Research,
and Evaluation, 370 L'Enfant Promenade, SW., Washington, DC 20447,
Attn: OPRE Reports Clearance Officer. All requests should be identified
by the title of the information collection. Email address:
OPREinfocollection@acf.hhs.gov. OMB Comment: OMB is required to make a
decision concerning the collection of information between 30 and 60
days after publication of this document in the Federal Register.
Therefore, a comment is best assured of having its full effect if OMB
receives it within 30 days of publication. Written comments and
recommendations for the proposed
[[Page 14809]]
information collection should be sent directly to the following: Office
of Management and Budget, Paperwork Reduction Project, Fax: 202-395-
6974, Attn: Desk Officer for the Administration for Children and
Families.
Dated: March 7, 2012.
Steven M. Hanmer,
Reports Clearance, Officer; Office of Planning, Research and
Evaluation.
[FR Doc. 2012-5951 Filed 3-12-12; 8:45 am]
BILLING CODE 4184-37-M
