Submission for OMB Review; Comment Request, 10813-10814 [2014-04192]
Download as PDF
10813
Federal Register / Vol. 79, No. 38 / Wednesday, February 26, 2014 / Notices
ANNUAL BURDEN ESTIMATES
Number of
respondents
Instrument
Application & Annual Report ...........................................................................
Estimated Total Annual Burden
Hours: 3,120
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: ACF Reports Clearance
Officer. All requests should be
identified by the title of the information
collection. Email address:
infocollection@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
information collection should be sent
directly to the following: Office of
Management and Budget, Paperwork
Reduction Project, Fax: 202–395–7285,
Email: OIRA_SUBMISSION@
OMB.EOP.GOV, Attn: Desk Officer for
the Administration for Children and
Families.
Robert Sargis,
Reports Clearance Officer.
[FR Doc. 2014–04094 Filed 2–25–14; 8:45 am]
BILLING CODE 4184–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
Submission for OMB Review;
Comment Request
Title: Child Support Enforcement
Program Expenditure Report (Form
Number of
responses per
respondent
52
OCSE–396) and the Child Support
Enforcement Program Collection Report
(Form OCSE–34).
OMB No.: 0970–0181.
Description: State and Tribal agencies
administering the Child Support
Enforcement Program under Title IV–D
of the Social Security Act are required
to provide information each fiscal
quarter to the Office of Child Support
Enforcement (OCSE) concerning
administrative expenditures and the
receipt and disposition of child support
payments from non-custodial parents.
State title IV–D agencies report quarterly
expenditures and collections using
Forms OCSE–396 and OCSE–34,
respectively. Tribal title IV–D agencies
report quarterly expenditures using
Form SF–425, as prescribed in program
regulations, and formerly reported
quarterly collections using only a
modified version of Form OCSE–34. The
information collected on these reporting
forms is used to compute quarterly grant
awards to States, the annual incentive
payments to States, and provides
valuable information on program
finances of States and Tribes. The
collected information is also included in
a published annual statistical and
financial report, available to the general
public.
In response to an earlier Federal
Register Notice (77 FR 72352 December,
2012), this agency received comments to
support the minor changes and
revisions to these forms at this time. As
we continued to discuss improvements
to these reporting forms with State and
Tribal grantees we list a few minor
revisions that have been incorporated to
facilitate grant award operations and
grantee financial reporting. These
revisions were limited to any changes
that allow Tribal grantees to, at least,
use the same quarterly collection report
submitted by State grantees.
Additionally, further clarification was
provided to reduce confusion over the
1
Average
burden hours
per response
60
Total burden
hours
3,120
inclusion of the Federal share of
funding in computations of claims and
to standardize treatment of claims.
Finally, there were minor revisions in
the title of the forms by reverting to the
original designation as Form OCSE–396
and Form OCSE–34 and minor changes
to the existing wording to improve
clarity and accuracy.
One respondent was concerned with
the Tribal and State governments using
the same OCSE–34 Form, which was
perceived to lead to an added burden
and confusion about the submission of
specific data elements. Our sense is that
the form is developed in a sufficiently
clear manner to inform respondents on
the data elements required by each type
of grantee. Furthermore, we consistently
provide outreach and technical
assistance to all grantees to ensure that
reporting burdens are clear and
minimized.
A few respondents provided technical
and clerical edits to the OCSE–396 Form
to increase accuracy and clarity. We
have incorporated many of the
requested edits and appreciate the
detailed and thoughtful comments.
One respondent was concerned that
the instructions to the OCSE–396 may
be creating an additional burden by
maintaining a 5 percent variance
threshold (an increase or decease in any
data element of Part 1 compared to that
same data element for the previous
quarter). While we are understanding of
this concern our position is that the
form will be used nationally and raising
the variance threshold above 5 percent
is not justified at this time.
Respondents: State and Tribal
agencies (including New York, Texas,
Washington, Puyallup Tribe, and Port
Gamble S’klallam Tribe) administering a
Child Support Enforcement Program.
tkelley on DSK3SPTVN1PROD with NOTICES
ANNUAL BURDEN ESTIMATES
Number of
respondents
Instrument
OCSE–396 .......................................................................................................
OCSE–34 .........................................................................................................
VerDate Mar<15>2010
17:24 Feb 25, 2014
Jkt 232001
PO 00000
Frm 00051
Fmt 4703
Sfmt 4703
Number of
responses per
respondent
54
114
E:\FR\FM\26FEN1.SGM
4
4
26FEN1
Average
burden hours
per response
6
14
Total burden
hours
1,296
6,384
10814
Federal Register / Vol. 79, No. 38 / Wednesday, February 26, 2014 / Notices
Estimated Total Annual Burden
Hours: 7,680.
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: ACF Reports Clearance
Officer. All requests should be
identified by the title of the information
collection. Email address:
infocollection@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 information collection should
be sent directly to the following: Office
of Management and Budget, Paperwork
Reduction Project, Fax: 202–395–7285,
Email: OIRA_SUBMISSION@
OMB.EOP.GOV, Attn: Desk Officer for
the Administration for Children and
Families.
Robert Sargis,
Reports Clearance Officer.
[FR Doc. 2014–04192 Filed 2–25–14; 8:45 am]
BILLING CODE 4184–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2014–N–0001]
Advisory Committees; Filing of Closed
Meeting Reports
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Center for Biologics Evaluation and
Research
Blood Products Advisory Committee,
Cellular, Tissue, and Gene Therapies
Advisory Committee, Vaccines and
Related Biological Products Advisory
Committee.
National Center for Toxicological
Research
Science Board to the National Center for
Toxicological Research.
Center for Tobacco Products
Tobacco Products Scientific Advisory
Committee.
Annual reports are available for
public inspections between 9 a.m. and
4 p.m., Monday through Friday at the
following locations:
(1) The Library of Congress, 101
Independence Ave. SE., James Madison
Memorial Bldg., Newspaper and Current
Periodical Reading Room, Rm. 133,
Washington, DC 20540; and
(2) The Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852.
Dated: February 21, 2014.
Jill Hartzler Warner,
Acting Associate Commissioner for Special
Medical Programs.
[FR Doc. 2014–04144 Filed 2–25–14; 8:45 am]
BILLING CODE 4160–01–P
Notice
The Food and Drug
Administration (FDA) is announcing
that, as required by the Federal
Advisory Committee Act, the Agency
has filed with the Library of Congress
the annual reports of those FDA
advisory committees that held closed
meetings during fiscal year 2013.
ADDRESSES: Copies are available from
the Division of Dockets Management
(HFA–305), Food and Drug
Administration, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852, 301–827–
6860.
FOR FURTHER INFORMATION CONTACT:
Teresa L. Hays, Committee Management
Officer, Advisory Committee and
Oversight Management Staff, Food and
Drug Administration, 10903 New
SUMMARY:
tkelley on DSK3SPTVN1PROD with NOTICES
Hampshire Ave., Silver Spring, MD
20993–0002, 301–796–8220.
SUPPLEMENTARY INFORMATION: Under
section 10(d) of the Federal Advisory
Committee Act (5 U.S.C. app.) and 21
CFR 14.60(d), FDA has filed with the
Library of Congress the annual reports
for the following FDA advisory
committees that held closed meetings
during the period October 1, 2012,
through September 30, 2013:
VerDate Mar<15>2010
17:24 Feb 25, 2014
Jkt 232001
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–D–0811]
Guidance for Industry: Enforcement
Policy Regarding Investigational New
Drug Requirements for Use of Fecal
Microbiota for Transplantation To Treat
Clostridium difficile Infection Not
Responsive to Standard Therapies;
Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or Agency) is
SUMMARY:
PO 00000
Frm 00052
Fmt 4703
Sfmt 4703
announcing the availability of a draft
guidance for industry entitled
‘‘Enforcement Policy Regarding
Investigational New Drug Requirements
for Use of Fecal Microbiota for
Transplantation to Treat Clostridium
difficile Infection Not Responsive to
Standard Therapies,’’ dated March 2014.
This draft guidance informs members of
the medical and scientific community
and other interested persons that we
intend to exercise enforcement
discretion regarding the investigational
new drug (IND) requirements for the use
of fecal microbiota for transplantation
(FMT) to treat C. difficile infection not
responding to standard therapies,
provided the licensed health care
provider treating the patient obtains
adequate informed consent from the
patient or his or her legally authorized
representative for use of the FMT
products, the stool is obtained from a
donor known to either the patient or the
licensed health care provider treating
the patient, and the donor and stool are
qualified by screening and testing
performed under the direction of the
licensed health care provider for the
purpose of providing the FMT product
to treat his or her patient. This draft
guidance, when finalized, is intended to
supersede the guidance document
entitled ‘‘Enforcement Policy Regarding
Investigational New Drug Requirements
for Use of Fecal Microbiota for
Transplantation to Treat Clostridium
difficile Infection Not Responsive to
Standard Therapies,’’ dated July 2013
(July 2013 Guidance).
DATES: Although you can comment on
any guidance at any time (see 21 CFR
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
either electronic or written comments
on the draft guidance by March 28,
2014.
ADDRESSES: Submit written requests for
single copies of the draft guidance 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
the office in processing your requests.
The draft guidance may also be obtained
by mail by calling CBER at 1–800–835–
4709 or 301–827–1800. 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
E:\FR\FM\26FEN1.SGM
26FEN1
Agencies
[Federal Register Volume 79, Number 38 (Wednesday, February 26, 2014)]
[Notices]
[Pages 10813-10814]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-04192]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Administration for Children and Families
Submission for OMB Review; Comment Request
Title: Child Support Enforcement Program Expenditure Report (Form
OCSE-396) and the Child Support Enforcement Program Collection Report
(Form OCSE-34).
OMB No.: 0970-0181.
Description: State and Tribal agencies administering the Child
Support Enforcement Program under Title IV-D of the Social Security Act
are required to provide information each fiscal quarter to the Office
of Child Support Enforcement (OCSE) concerning administrative
expenditures and the receipt and disposition of child support payments
from non-custodial parents. State title IV-D agencies report quarterly
expenditures and collections using Forms OCSE-396 and OCSE-34,
respectively. Tribal title IV-D agencies report quarterly expenditures
using Form SF-425, as prescribed in program regulations, and formerly
reported quarterly collections using only a modified version of Form
OCSE-34. The information collected on these reporting forms is used to
compute quarterly grant awards to States, the annual incentive payments
to States, and provides valuable information on program finances of
States and Tribes. The collected information is also included in a
published annual statistical and financial report, available to the
general public.
In response to an earlier Federal Register Notice (77 FR 72352
December, 2012), this agency received comments to support the minor
changes and revisions to these forms at this time. As we continued to
discuss improvements to these reporting forms with State and Tribal
grantees we list a few minor revisions that have been incorporated to
facilitate grant award operations and grantee financial reporting.
These revisions were limited to any changes that allow Tribal grantees
to, at least, use the same quarterly collection report submitted by
State grantees. Additionally, further clarification was provided to
reduce confusion over the inclusion of the Federal share of funding in
computations of claims and to standardize treatment of claims. Finally,
there were minor revisions in the title of the forms by reverting to
the original designation as Form OCSE-396 and Form OCSE-34 and minor
changes to the existing wording to improve clarity and accuracy.
One respondent was concerned with the Tribal and State governments
using the same OCSE-34 Form, which was perceived to lead to an added
burden and confusion about the submission of specific data elements.
Our sense is that the form is developed in a sufficiently clear manner
to inform respondents on the data elements required by each type of
grantee. Furthermore, we consistently provide outreach and technical
assistance to all grantees to ensure that reporting burdens are clear
and minimized.
A few respondents provided technical and clerical edits to the
OCSE-396 Form to increase accuracy and clarity. We have incorporated
many of the requested edits and appreciate the detailed and thoughtful
comments.
One respondent was concerned that the instructions to the OCSE-396
may be creating an additional burden by maintaining a 5 percent
variance threshold (an increase or decease in any data element of Part
1 compared to that same data element for the previous quarter). While
we are understanding of this concern our position is that the form will
be used nationally and raising the variance threshold above 5 percent
is not justified at this time.
Respondents: State and Tribal agencies (including New York, Texas,
Washington, Puyallup Tribe, and Port Gamble S'klallam Tribe)
administering a Child Support Enforcement Program.
Annual Burden Estimates
----------------------------------------------------------------------------------------------------------------
Number of Average burden
Instrument Number of responses per hours per Total burden
respondents respondent response hours
----------------------------------------------------------------------------------------------------------------
OCSE-396........................................ 54 4 6 1,296
OCSE-34......................................... 114 4 14 6,384
----------------------------------------------------------------------------------------------------------------
[[Page 10814]]
Estimated Total Annual Burden Hours: 7,680.
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: ACF Reports Clearance Officer. All
requests should be identified by the title of the information
collection. Email address: infocollection@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
information collection should be sent directly to the following: Office
of Management and Budget, Paperwork Reduction Project, Fax: 202-395-
7285, Email: OIRA_SUBMISSION@OMB.EOP.GOV, Attn: Desk Officer for the
Administration for Children and Families.
Robert Sargis,
Reports Clearance Officer.
[FR Doc. 2014-04192 Filed 2-25-14; 8:45 am]
BILLING CODE 4184-01-P