Proposed Information Collection Activity; Comment Request, 20024-20025 [2012-7923]
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Federal Register / Vol. 77, No. 64 / Tuesday, April 3, 2012 / Notices
1, 2011. A final rule regarding selected
provisions of the IFR was published on
December 7, 2011 (76 FR 76574, CMS–
9998–FC) and an interim final rule
regarding an issue not included in
issuers’ reporting obligations
(disbursement of rebates by non-federal
governmental plans) was also published
December 7, 2011 (76 FR 76596, CMS–
9998–IFC2). Both rules published on
December 7, 2011 are effective January
1, 2012. Each issuer is required to
submit annually MLR data, including
information about any rebates it must
provide, on a form prescribed by CMS,
for each State in which the issuer
conducts business. Each issuer is also
required to provide a rebate notice to
each enrollee that is due a rebate
payment for any given MLR reporting
year. Additionally, each issuer is
required to maintain for a period of
seven years all documents, records and
other evidence that support the data
included in each issuer’s annual report
to the Secretary.
The original 60-day comment period
began on December 16, 2011 and
pertained to the MLR Annual Reporting
Form, and closed on February 14, 2012.
On February 16, we published an
amended PRA package with Notices to
Consumers and reopened the public
comment period until March 2, 2012 to
accommodate comments on the
amendments to the PRA package. We
received a total of 15 public comments
regarding the Annual Reporting Form
and 11 public comments regarding the
Notices to Consumers and Instructions
for these notices. Most public comments
addressed multiple issues. We have
taken into consideration all the
proposed suggestions and have made
changes to the Annual Reporting Form
and Instructions, as well as to the
Notices to Consumers and Instructions.
In addition, CMS is adjusting the
estimated burden that correlates with
the Rebate Notices and the MLR
Information Notices.
Form Number: CMS–10418 (OCN:
0938–New); Frequency: Annual
submission for each respondent;
Affected Public: Private Sector: Business
or other for-profits and not-for-profit
institutions; Number of Respondents:
527; Number of Responses: 5,530; Total
Annual Hours: 352,563. (For policy
questions regarding this collection,
contact Carol Jimenez at (301) 492–
4457. For all other issues, call (410)
786–1326.)
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.hhs.gov/
PaperworkReductionActof1995, 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.
To be assured consideration,
comments and recommendations for the
proposed information collections must
be received by the OMB desk officer at
the address below, no later than 5 p.m.
on May 3, 2012.
OMB, Office of Information and
Regulatory Affairs, Attention: CMS
Desk Officer, Fax Number: (202) 395–
6974, Email:
OIRA_submission@omb.eop.gov.
Dated: March 30, 2012.
Martique Jones,
Director, Regulations Development Group,
Division B, Office of Strategic Operations and
Regulatory Affairs.
[FR Doc. 2012–8080 Filed 4–2–12; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
OMB No.: New Collection.
Description: The Study of
Coordination of Tribal TANF and Child
Welfare Services is sponsored by the
Office of Planning, Research and
Evaluation (OPRE), Administration for
Children and Families of the U.S.
Department of Health and Human
Services. The study examines the
approaches and strategies utilized by
tribes and tribal organizations that were
awarded the grants for Coordination of
Tribal TANF and Child Welfare Services
to Tribal Families at Risk of Child
Abuse or Neglect.
The descriptive study of these
programs that serve tribal communities
will document the way in which the
tribal grantees are creating and adapting
culturally relevant and appropriate
approaches, systems, and programs to
increase coordination and enhance
service delivery to address child abuse
and neglect. The study will also
document challenges faced and lessons
learned to inform the field of practice as
well as policymakers and funders at
various levels.
The proposed information collection
activities consist of semi-structured
interviews, conducted at each of the 14
tribal communities, and a grantee
feedback survey on the usefulness of
periodically held cross-grantee learning
events.
Respondents: Program director(s),
tribal TANF and child welfare staff and
supervisors, program partners, and
tribal leaders or elders. The information
collection does not include direct
interaction with individuals or families
that receive the services.
Administration for Children and
Families
Proposed Information Collection
Activity; Comment Request
Title: Study of Coordination of Tribal
TANF and Child Welfare Services.
ANNUAL BURDEN ESTIMATES
Annual
number of
respondents
mstockstill on DSK4VPTVN1PROD with NOTICES
Instrument
Interview Protocol for Program Staff .............................................................
Interview Protocol for TANF and CW Staff ...................................................
Interview Protocol for Tribal or Community Partners ....................................
Interview Protocol for Tribal Leaders or Elders .............................................
Feedback Form for Community of Learning Events .....................................
Estimated Total Annual Burden
Hours: 153.
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Average burden
hours per
response
3
3
3
3
5
1.5
1
.75
1
.15
9
19
9
9
10
In compliance with the requirements
of Section 3506(c)(2)(A) of the
PO 00000
Number of
responses per
respondent
Total annual
burden hours
Paperwork Reduction Act of 1995, the
Administration for Children and
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57
20
27
8
Federal Register / Vol. 77, No. 64 / Tuesday, April 3, 2012 / Notices
Families is soliciting public comment
on the specific aspects of the
information collection described above.
Copies of the proposed collection of
information can be obtained and
comments may be forwarded 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.
Email address:
OPREinfocollection@acf.hhs.gov. All
requests should be identified by the title
of the information collection.
The Department specifically requests
comments on (a) Whether the proposed
collection of information is necessary
for the proper performance of the
functions of the agency, including
whether the information shall have
practical utility; (b) the accuracy of the
agency’s estimate of the burden of the
proposed collection of information; (c)
the quality, utility, and clarity of the
information to be collected; and (d)
ways to minimize the burden of the
collection of information on
respondents, including through the use
of automated collection techniques or
other forms of information technology.
Consideration will be given to
comments and suggestions submitted
within 60 days of this publication.
400B, Rockville, MD 20850, 301–796–
7726, ila.mizrachi@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: On
January 4, 2012, the Agency submitted
a proposed collection of information
entitled ‘‘Blood Establishment
Registration and Product Listing, Form
FDA 2830’’ to OMB for review and
clearance under 44 U.S.C. 3507. An
Agency may not conduct or sponsor,
and a person is not required to respond
to, a collection of information unless it
displays a currently valid OMB control
number. OMB has now approved the
information collection and has assigned
OMB control number 0910–0052. The
approval expires on March 31, 2015. A
copy of the supporting statement for this
information collection is available on
the Internet at https://www.reginfo.gov/
public/do/PRAMain.
Robert Sargis,
Reports Clearance Officer.
Draft Guidance for Industry on
Compliance Policy for Reporting Drug
Sample Distribution Information;
Availability
[FR Doc. 2012–7923 Filed 4–2–12; 8:45 am]
BILLING CODE 4184–35–P
Dated: March 28, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012–7915 Filed 4–2–12; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2012–D–0300]
AGENCY:
Food and Drug Administration,
HHS.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
ACTION:
Food and Drug Administration
SUMMARY:
[Docket No. FDA–2011–N–0508]
Agency Information Collection
Activities; Announcement of Office of
Management and Budget Approval;
Blood Establishment Registration and
Product Listing, Form FDA 2830
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing
that a collection of information entitled
‘‘Blood Establishment Registration and
Product Listing, Form FDA 2830’’ has
been approved by the Office of
Management and Budget (OMB) under
the Paperwork Reduction Act of 1995.
FOR FURTHER INFORMATION CONTACT: Ila
S. Mizrachi, Office of Information
Management, Food and Drug
Administration, 1350 Piccard Dr., PI50–
mstockstill on DSK4VPTVN1PROD with NOTICES
SUMMARY:
VerDate Mar<15>2010
16:19 Apr 02, 2012
Jkt 226001
Notice.
The Food and Drug
Administration (FDA) is announcing the
availability of a draft guidance for
industry entitled ‘‘Compliance Policy on
Reporting Drug Sample Distribution
Information Under the Affordable Care
Act.’’ This draft guidance is intended to
provide information regarding the
Agency’s implementation of the drug
sample transparency reporting
provisions of section 6004 of the Patient
Protection and Affordable Care Act. The
draft guidance notifies entities covered
by the reporting obligations in section
6004 that FDA does not intend to object
until at least October 1, 2012, if
manufacturers and authorized
distributors of record (ADRs) do not
submit information under those
reporting provisions and that the
Agency intends to provide notice before
revising its exercise of discretion with
respect to compliance.
DATES: Although you can comment on
any guidance at any time (see 21 CFR
PO 00000
Frm 00031
Fmt 4703
Sfmt 4703
20025
10.115(g)(5)), to ensure that the Agency
considers your comment on this draft
guidance before it begins work on the
final version of the guidance, submit
electronic or written comments on the
draft guidance by June 4, 2012.
ADDRESSES: Submit written requests for
single copies of the draft guidance to the
Division of Drug Information, Center for
Drug Evaluation and Research, Food
and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 2201,
Silver Spring, MD 20993–0002 or to the
Office of Communication, Outreach and
Development (HFM–40), Center for
Biologics Evaluation and Research
(CBER), Food and Drug Administration,
1401 Rockville Pike, Suite 200N,
Rockville, MD 20852–1448. Send one
self-addressed adhesive label to assist
that office in processing your requests.
See the SUPPLEMENTARY INFORMATION
section for electronic access to the draft
guidance document.
Submit electronic comments on the
draft guidance 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.
FOR FURTHER INFORMATION CONTACT:
Donovan F. Duggan, Jr., Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 4288,
Silver Spring, MD 20993–0002, 301–
796–0584; Paul Loebach, Center for
Drug Evaluation and Research, Food
and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 4268,
Silver Spring, MD 20993–0002, 301–
796–2173; or Stephen Ripley, Center for
Biologics Evaluation and Research
(HFM–17), Food and Drug
Administration, 1401 Rockville Pike,
Suite 200N, Rockville, MD 20852–1448,
301–827–6210.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of
a draft guidance for industry entitled
‘‘Compliance Policy on Reporting Drug
Sample Distribution Information.’’ On
March 23, 2010, the Affordable Care Act
was signed into law. Among its many
provisions, section 6004 of the
Affordable Care Act amended the Social
Security Act by adding section 1128H
(42 U.S.C. 1320a–7i). This new section
requires the submission of certain drug
sample information to FDA not later
than April 1 of each year, beginning
April 1, 2012.
The draft guidance is intended to
provide information regarding the
Agency’s implementation of section
E:\FR\FM\03APN1.SGM
03APN1
]]>Agencies
[Federal Register Volume 77, Number 64 (Tuesday, April 3, 2012)]
[Notices]
[Pages 20024-20025]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-7923]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Administration for Children and Families
Proposed Information Collection Activity; Comment Request
Title: Study of Coordination of Tribal TANF and Child Welfare
Services.
OMB No.: New Collection.
Description: The Study of Coordination of Tribal TANF and Child
Welfare Services is sponsored by the Office of Planning, Research and
Evaluation (OPRE), Administration for Children and Families of the U.S.
Department of Health and Human Services. The study examines the
approaches and strategies utilized by tribes and tribal organizations
that were awarded the grants for Coordination of Tribal TANF and Child
Welfare Services to Tribal Families at Risk of Child Abuse or Neglect.
The descriptive study of these programs that serve tribal
communities will document the way in which the tribal grantees are
creating and adapting culturally relevant and appropriate approaches,
systems, and programs to increase coordination and enhance service
delivery to address child abuse and neglect. The study will also
document challenges faced and lessons learned to inform the field of
practice as well as policymakers and funders at various levels.
The proposed information collection activities consist of semi-
structured interviews, conducted at each of the 14 tribal communities,
and a grantee feedback survey on the usefulness of periodically held
cross-grantee learning events.
Respondents: Program director(s), tribal TANF and child welfare
staff and supervisors, program partners, and tribal leaders or elders.
The information collection does not include direct interaction with
individuals or families that receive the services.
Annual Burden Estimates
----------------------------------------------------------------------------------------------------------------
Average
Annual number Number of burden
Instrument of responses per hours Total annual
respondents respondent per burden hours
response
----------------------------------------------------------------------------------------------------------------
Interview Protocol for Program Staff.................. 9 3 1.5 41
Interview Protocol for TANF and CW Staff.............. 19 3 1 57
Interview Protocol for Tribal or Community Partners... 9 3 .75 20
Interview Protocol for Tribal Leaders or Elders....... 9 3 1 27
Feedback Form for Community of Learning Events........ 10 5 .15 8
----------------------------------------------------------------------------------------------------------------
Estimated Total Annual Burden Hours: 153.
In compliance with the requirements of Section 3506(c)(2)(A) of the
Paperwork Reduction Act of 1995, the Administration for Children and
[[Page 20025]]
Families is soliciting public comment on the specific aspects of the
information collection described above. Copies of the proposed
collection of information can be obtained and comments may be forwarded
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. Email
address: OPREinfocollection@acf.hhs.gov. All requests should be
identified by the title of the information collection.
The Department specifically requests comments on (a) Whether the
proposed collection of information is necessary for the proper
performance of the functions of the agency, including whether the
information shall have practical utility; (b) the accuracy of the
agency's estimate of the burden of the proposed collection of
information; (c) the quality, utility, and clarity of the information
to be collected; and (d) ways to minimize the burden of the collection
of information on respondents, including through the use of automated
collection techniques or other forms of information technology.
Consideration will be given to comments and suggestions submitted
within 60 days of this publication.
Robert Sargis,
Reports Clearance Officer.
[FR Doc. 2012-7923 Filed 4-2-12; 8:45 am]
BILLING CODE 4184-35-P
