Submission for OMB Review; Comment Request, 48165-48166 [2011-19974]
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48165
Federal Register / Vol. 76, No. 152 / Monday, August 8, 2011 / Notices
Dated: August 1, 2011.
Daniel Holcomb,
Reports Clearance Officer, Centers for Disease
Control and Prevention.
[FR Doc. 2011–20033 Filed 8–5–11; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
Submission for OMB Review;
Comment Request
Title: Refugee Assistance Program
Estimates CMA—ORR–1.
OMB No.: 0970–0030.
Description: The ORR–1, Cash and
Medical Assistance (CMA) Program
Estimates, is the application for grants
under the CMA program. The
application is required by the Office of
Refugee Resettlement (ORR) program
regulations at 45 CFR 400.11(b). The
regulation specifies that States must
submit, as their application for this
program, estimates of the projected costs
they anticipate incurring in providing
cash and medical assistance for eligible
recipients and the costs of administering
the program. Under the CMA program,
States are reimbursed for the costs of
providing these services and benefits for
eight months after an eligible recipient
arrives in this country. The eligible
recipients for these services and benefits
are refugees, Amerasians, Cuban and
Haitian Entrants, asylees, Afghans and
Iraqi with Special Immigrant Visas, and
victims of a severe form of trafficking.
States that provide services for
unaccompanied refugee minors also
provide an estimate for the cost of these
services for the year for which they are
applying for a grant.
Respondents:
Instrument
Number of
respondents
Number of
responses per
respondent
Average
burden hours
per response
Total burden
hours
ORR–1 .............................................................................................................
46
1
0.60
27.60
Estimated Total Annual Burden
Hours: 27.60.
Additional Information: Copies of the
proposed collection may be obtained by
writing to the Administration for
Children and Families, Office of
Administration, Office of Information
Services, 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. E-mail 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,
E-mail:
OIRA_SUBMISSION@OMB.eop.gov,
Attn: Desk Officer for the
Administration for Children and
Families.
Robert Sargis,
Reports Clearance Officer.
[FR Doc. 2011–19973 Filed 8–5–11; 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: Low Income Home Energy
Assistance Program (LIHEAP) Carryover
and Reallotment Report.
OMB No.: 0970–0106.
Description: The LIHEAP statute and
regulations require LIHEAP grantees to
report certain information to HHS
concerning funds forwarded and funds
subject to reallotment. The 1994
reauthorization of the LIHEAP statute,
the Human Service Amendments of
1994 (Pub. L. 103–252), requires that the
Carryover and Reallotment Report for
one fiscal year be submitted to HHS by
the grantee before the allotment for the
next fiscal year may be awarded.
The Administration for Children and
Families is requesting no changes in the
collection of data with the Carryover
and Reallotment Report, a form for the
collection of data, and the Simplified
Instructions for Timely Obligations of
LIHEAP Funds and Reporting Funds for
Carryover and Reallotment. The form
clarifies the information being requested
and ensures the submission of all the
required information. The form
facilitates our response to numerous
queries each year concerning the
amounts of obligated funds. Use of the
form is voluntary. Grantees have the
option to use another format.
Respondents: State Governments,
Tribal Governments, Insular Areas, the
District of Columbia, and the
Commonwealth of Puerto Rico.
ANNUAL BURDEN ESTIMATES
Number of
respondents
Number of
responses per
respondent
Average
burden hours
per response
Total burden
hours
Carryover and Reallotment Report ..................................................................
mstockstill on DSK4VPTVN1PROD with NOTICES
Instrument
192
1
3
576
Estimated Total Annual Burden
Hours: 576.
Additional Information: Copies of the
proposed collection may be obtained by
writing to the Administration for
Children and Families, Office of
VerDate Mar<15>2010
18:57 Aug 05, 2011
Jkt 223001
Administration, Office of Information
Services, 370 L’Enfant Promenade, SW.,
Washington, DC 20447, Attn: ACF
Reports Clearance Officer. All requests
should be identified by the title of the
PO 00000
Frm 00049
Fmt 4703
Sfmt 4703
information collection. E-mail 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
E:\FR\FM\08AUN1.SGM
08AUN1
48166
Federal Register / Vol. 76, No. 152 / Monday, August 8, 2011 / Notices
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,
E-mail: OIRA_SUBMISSION@OMB.eop.
gov, Attn: Desk Officer for the
Administration for Children and
Families.
Robert Sargis,
Reports Clearance Officer.
[FR Doc. 2011–19974 Filed 8–5–11; 8:45 am]
BILLING CODE 4184–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–N–0085]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Cooperative
Manufacturing Arrangements for
Licensed Biologics
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing
that a proposed collection of
information has been submitted to the
Office of Management and Budget
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
DATES: Fax written comments on the
collection of information by September
7, 2011.
ADDRESSES: To ensure that comments on
the information collection are received,
OMB recommends that written
comments be faxed to the Office of
Information and Regulatory Affairs,
OMB, Attn: FDA Desk Officer, Fax: 202–
395–7285, or e-mailed to
oira_submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910–0629. Also
include the FDA docket number found
in brackets in the heading of this
document.
mstockstill on DSK4VPTVN1PROD with NOTICES
SUMMARY:
FOR FURTHER INFORMATION CONTACT:
Juanmanuel Vilela, Office of
Information Management, Food and
Drug Administration, 1350 Piccard Dr.,
PI50–400B, Rockville, MD 20850, 301–
796–7651,
juanmanuel.vilela@fda.hhs.gov.
VerDate Mar<15>2010
18:57 Aug 05, 2011
Jkt 223001
In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
SUPPLEMENTARY INFORMATION:
Guidance for Industry: Cooperative
Manufacturing Arrangements For
Licensed Biologics—(OMB Control
Number 0910–0629)—Extension
The guidance document provides
information concerning cooperative
manufacturing arrangements applicable
to biological products subject to
licensure under section 351 of the
Public Health Service Act (42 U.S.C.
262). The guidance addresses several
types of manufacturing arrangements
(i.e., short supply arrangements, divided
manufacturing arrangements, shared
manufacturing arrangements, and
contract manufacturing arrangements)
and describes certain reporting and
recordkeeping responsibilities,
associated with these arrangements,
including the following: (1) Notification
of all important proposed changes to
production and facilities; (2)
notification of results of tests and
investigations regarding or possibly
impacting the product; (3) notification
of products manufactured in a contract
facility; and (4) standard operating
procedures.
(1) Notification of All Important
Proposed Changes to Production and
Facilities
Each licensed manufacturer in a
divided manufacturing arrangement or
shared manufacturing arrangement must
notify the appropriate FDA center
regarding proposed changes in the
manufacture, testing, or specifications of
its product, in accordance with § 601.12
(21 CFR 601.12). In the guidance, we
recommend that each licensed
manufacturer that proposes such a
change should also inform other
participating licensed manufacturer(s)
of the proposed change.
For contract manufacturing
arrangements, we recommend that the
contract manufacturer should share
with the license manufacturer all
important proposed changes to
production and facilities (including
introduction of new products or at
inspection). The license holder is
responsible for reporting these changes
to FDA (§ 601.12).
(2) Notification of Results of Tests and
Investigations Regarding or Possibly
Impacting the Product
In the guidance, we recommend the
following for contract manufacturing
arrangements:
PO 00000
Frm 00050
Fmt 4703
Sfmt 4703
• The contract manufacturer should
fully inform the license manufacturer of
the results of all tests and investigations
regarding or possibly having an impact
on the product; and
• The license manufacturer should
obtain assurance from the contractor
that any FDA list of inspectional
observations will be shared with the
license manufacturer to allow
evaluation of its impact on the purity,
potency, and safety of the license
manufacturer’s product.
(3) Notification of Products
Manufactured in a Contract Facility
In the guidance, we recommend for
contract manufacturing arrangements
that a license manufacturer cross
reference a contract manufacturing
facility’s Master Files only in
circumstances involving certain
proprietary information of the contract
manufacturer, such as a list of all
products manufactured in a contract
facility. In this situation, the license
manufacturer should be kept informed
of the types or categories of all products
manufactured in the contract facility.
(4) Standard Operating Procedures
In the guidance, we remind the
license manufacturer that the license
manufacturer assumes responsibility for
compliance with the applicable product
and establishment standards (21 CFR
600.3(t)). Therefore, if the license
manufacturer enters into an agreement
with a contract manufacturing facility,
the license manufacturer must ensure
that the facility complies with the
applicable standards. An agreement
between a license manufacturer and a
contract manufacturing facility normally
includes procedures to regularly assess
the contract manufacturing facility’s
compliance. These procedures may
include, but are not limited to, review
of records and manufacturing deviations
and defects, and periodic audits.
For shared manufacturing
arrangements, each manufacturer must
submit a separate biologics license
application (BLA) describing the
manufacturing facilities and operations
applicable to the preparation of that
manufacturer’s biological substance or
product (§ 601.2(a)). In the guidance, we
state that we expect the manufacturer
that prepares (or is responsible for the
preparation of) the product in final form
for commercial distribution to assume
primary responsibility for providing
data demonstrating the safety, purity,
and potency of the final product. We
also state that we expect the licensed
finished product manufacturer to be
primarily responsible for any postapproval obligations, such as
E:\FR\FM\08AUN1.SGM
08AUN1
Agencies
[Federal Register Volume 76, Number 152 (Monday, August 8, 2011)]
[Notices]
[Pages 48165-48166]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-19974]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Administration for Children and Families
Submission for OMB Review; Comment Request
Title: Low Income Home Energy Assistance Program (LIHEAP) Carryover
and Reallotment Report.
OMB No.: 0970-0106.
Description: The LIHEAP statute and regulations require LIHEAP
grantees to report certain information to HHS concerning funds
forwarded and funds subject to reallotment. The 1994 reauthorization of
the LIHEAP statute, the Human Service Amendments of 1994 (Pub. L. 103-
252), requires that the Carryover and Reallotment Report for one fiscal
year be submitted to HHS by the grantee before the allotment for the
next fiscal year may be awarded.
The Administration for Children and Families is requesting no
changes in the collection of data with the Carryover and Reallotment
Report, a form for the collection of data, and the Simplified
Instructions for Timely Obligations of LIHEAP Funds and Reporting Funds
for Carryover and Reallotment. The form clarifies the information being
requested and ensures the submission of all the required information.
The form facilitates our response to numerous queries each year
concerning the amounts of obligated funds. Use of the form is
voluntary. Grantees have the option to use another format.
Respondents: State Governments, Tribal Governments, Insular Areas,
the District of Columbia, and the Commonwealth of Puerto Rico.
Annual Burden Estimates
----------------------------------------------------------------------------------------------------------------
Number of Average burden
Instrument Number of responses per hours per Total burden
respondents respondent response hours
----------------------------------------------------------------------------------------------------------------
Carryover and Reallotment Report............ 192 1 3 576
----------------------------------------------------------------------------------------------------------------
Estimated Total Annual Burden Hours: 576.
Additional Information: Copies of the proposed collection may be
obtained by writing to the Administration for Children and Families,
Office of Administration, Office of Information Services, 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. E-mail 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
[[Page 48166]]
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, E-mail: OIRA_SUBMISSION@OMB.eop.gov, Attn: Desk Officer for the
Administration for Children and Families.
Robert Sargis,
Reports Clearance Officer.
[FR Doc. 2011-19974 Filed 8-5-11; 8:45 am]
BILLING CODE 4184-01-P