Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request, 13805-13806 [2016-05730]
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Federal Register / Vol. 81, No. 50 / Tuesday, March 15, 2016 / Notices
submission. You should submit two
copies total. One copy will include the
information you claim to be confidential
with a heading or cover note that states
‘‘THIS DOCUMENT CONTAINS
CONFIDENTIAL INFORMATION.’’ The
Agency will review this copy, including
the claimed confidential information, in
its consideration of comments. The
second copy, which will have the
claimed confidential information
redacted/blacked out, will be available
for public viewing and posted on https://
www.regulations.gov. Submit both
copies to the Division of Dockets
Management. If you do not wish your
name and contact information to be
made publicly available, you can
provide this information on the cover
sheet and not in the body of your
comments and you must identify this
information as ‘‘confidential.’’ Any
information marked as ‘‘confidential’’
will not be disclosed except in
accordance with 21 CFR 10.20 and other
applicable disclosure law. For more
information about FDA’s posting of
comments to public dockets, see 80 FR
56469, September 18, 2015, or access
the information at: https://www.fda.gov/
regulatoryinformation/dockets/
default.htm.
Docket: For access to the docket to
read background documents or the
electronic and written/paper comments
received, go to https://
www.regulations.gov and insert the
docket number, found in brackets in the
heading of this document, into the
‘‘Search’’ box and follow the prompts
and/or go to the Division of Dockets
Management, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT:
Mark Ascione, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 1150,
Silver Spring, MD 20993–0002, 301–
796–7652, FAX: 301–847–8443.
SUPPLEMENTARY INFORMATION:
asabaliauskas on DSK3SPTVN1PROD with NOTICES
I. Background
The Patient Protection and Affordable
Care Act of 2010 (Pub. L. 111–148)
amended the Public Health Service Act
to create an abbreviated licensure
pathway for biological products that are
demonstrated to be ‘‘biosimilar’’ to or
‘‘interchangeable’’ with an FDAlicensed biological product. The Federal
Food, Drug, and Cosmetic Act (the
FD&C Act), as amended by BsUFA (Title
IV of the Food and Drug Administration
Safety and Innovation Act, Pub. L. 112–
114), authorizes FDA to assess and
collect fees for biosimilar biological
products from October 2012 through
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17:40 Mar 14, 2016
Jkt 238001
September 2017. FDA uses these fees to
expedite the review process for
biosimilar biological products.
Biosimilar biological products represent
an important public health benefit, with
the potential to offer life-saving or lifealtering benefits at reduced cost to the
patient. BsUFA facilitates the
development of safe and effective
biosimilar products for the American
public.
As part of BsUFA, FDA is required to
contract with an independent
accounting or consulting firm to study
the workload volume and full costs
associated with the process for the
review of biosimilar biological product
applications. This notice solicits
comments on the final report. The final
report is described in section 744I(d) of
the FD&C Act (21 U.S.C. 379j–53(d))
(https://uscode.house.gov/
view.xhtml?req=granuleid:U.S.C.prelim-title21-section379j53&num=0&edition=prelim), as
amended by the Food and Drug
Administration Safety and Innovation
Act enacted in 2012 (https://
www.gpo.gov/fdsys/pkg/PLAW112publ144/pdf/PLAW112publ144.pdf). (FDA has verified the
Web site addresses, as of the date this
document publishes in the Federal
Register, but Web sites are subject to
change over time.)
II. Electronic Access
The final report can be accessed at
https://www.fda.gov/ForIndustry/
UserFees/BiosimilarUserFeeActBsUFA/
ucm459682.htm.
Dated: March 9, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016–05720 Filed 3–14–16; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Agency Information Collection
Activities: Submission to OMB for
Review and Approval; Public Comment
Request
Health Resources and Services
Administration, HHS.
ACTION: Notice.
AGENCY:
In compliance with Section
3507(a)(1)(D) of the Paperwork
Reduction Act of 1995, the Health
Resources and Services Administration
(HRSA) has submitted an Information
Collection Request (ICR) to the Office of
SUMMARY:
PO 00000
Frm 00035
Fmt 4703
Sfmt 4703
13805
Management and Budget (OMB) for
review and approval. Comments
submitted during the first public review
of this ICR will be provided to OMB.
OMB will accept further comments from
the public during the review and
approval period.
DATES: Comments on this ICR should be
received no later than April 14, 2016.
ADDRESSES: Submit your comments,
including the Information Collection
Request Title, to the desk officer for
HRSA, either by email to OIRA_
submission@omb.eop.gov or by fax to
202–395–5806.
FOR FURTHER INFORMATION CONTACT: To
request a copy of the clearance requests
submitted to OMB for review, email the
HRSA Information Collection Clearance
Officer at paperwork@hrsa.gov or call
(301) 443–1984.
SUPPLEMENTARY INFORMATION:
Information Collection Request Title:
Maternal and Child Health Bureau
Performance Measures for Discretionary
Grants
OMB No.: 0915–0298—Revision
Abstract: The Maternal and Child
Health Bureau’s (MCHB) Discretionary
Grant Information System (DGIS)
electronically captures performance
measure, program, financial, and
abstract data, and products and
publications about these discretionary
grants from the grantees. The data
collected are used by MCHB project
officers to monitor and assess grantee
performance as well as assist in
monitoring and evaluating MCHB’s
programs.
Need and Proposed Use of the
Information: The Health Resources and
Services Administration (HRSA)
proposes to continue using reporting
requirements for grant programs
administered by MCHB, including
national performance measures as
previously approved by OMB, and in
accordance with the ‘‘Government
Performance and Results Act (GPRA) of
1993’’ (Pub. L. 103–62). This Act
requires the establishment of
measurable goals for Federal Programs
that can be reported as part of the
budgetary process, thus linking funding
decisions with performance.
Performance measures for MCHB
discretionary grants were initially
approved in January 2003. Approval
from OMB is being sought to continue
the use of performance measures for
these grants. The revised performance
measures are categorized by population
domains (Adolescent Health, Child
Health, Children with Special Health
Care Needs, Lifecourse/Crosscutting,
Maternal/Women Health, and Perinatal/
Infant Health) consistent with Title V,
E:\FR\FM\15MRN1.SGM
15MRN1
13806
Federal Register / Vol. 81, No. 50 / Tuesday, March 15, 2016 / Notices
with the addition of a Capacity Building
domain, specific to DGIS. There are also
program-specific measures included for
a subset of discretionary grant programs
including the Healthy Start program,
Emergency Medical Services for
Children program, and programs within
the Division of MCH Workforce
Development. Grant programs will be
assigned measures in the domains that
are appropriate for their activities.
Comments were received related to
structure, content, and volume of
performance measures during the 60day public comment period and those
comments were taken into consideration
in the final revision of the DGIS
performance measures and overall DGIS
data collection.
MCHB’s purpose in revising the
performance measures is to better
measure progress toward program goals.
These program goals include alignment
with and support of the Title V Block
Grant, specifically population domains
and National Performance Measures,
where reasonable. Further, the revised
measures will more accurately capture
the scope of services provided through
this grant funding. The overall number
of performance measures has been
reduced from prior DGIS data
collection, and the average number of
performance measures each grantee will
be required to report is reduced as well.
Further, the structure of the data
collection has been revised to better
measure the various models of programs
and the services each funded program
provides. This revision will allow a
more accurate and detailed picture of
the full scope of services provided
through grant programs administered by
MCHB. The data collected are also used
by MCHB project officers to monitor and
assess grantee performance as well as
assist in monitoring and evaluating
MCHB’s programs.
Likely Respondents: Discretionary
grant programs administered by the
Maternal and Child Health Bureau.
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 ICR are
summarized in the table below.
TOTAL ESTIMATED ANNUALIZED BURDEN—HOURS
Number of
respondents
Form name
Number of
responses per
respondent
Total responses
Average
burden per
response
(in hours)
Total burden
hours
Grant Report ..........................................
600
1
600
36
21,600
Total ................................................
600
1
600
36
21,600
Jackie Painter,
Director, Division of the Executive Secretariat.
[FR Doc. 2016–05730 Filed 3–14–16; 8:45 am]
BILLING CODE 4165–15–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Office of the Secretary
[Document Identifier: HHS–OS–0945–0004
60D]
Agency Information Collection
Activities; Proposed Collection; Public
Comment Request
Office of the Secretary, HHS.
Notice.
AGENCY:
ACTION:
In compliance with section
3506(c)(2)(A) of the Paperwork
Reduction Act of 1995, the Office of the
Secretary (OS), Department of Health
and Human Services, announces plans
to submit an Information Collection
Request (ICR), described below, to the
asabaliauskas on DSK3SPTVN1PROD with NOTICES
SUMMARY:
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17:40 Mar 14, 2016
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Office of Management and Budget
(OMB). The ICR is for extending the use
of the approved information collection
assigned OMB control number 0945–
0004, which expires on May 31, 2016.
Prior to submitting the ICR to OMB, OS
seeks comments from the public
regarding the burden estimate, below, or
any other aspect of the ICR.
DATES: Comments on the ICR must be
received on or before May 16, 2016.
ADDRESSES: Submit your comments to
Information.CollectionClearance@
hhs.gov or by calling (202) 690–6162.
FOR FURTHER INFORMATION CONTACT:
Information Collection Clearance staff,
Information.CollectionClearance@
hhs.gov or (202) 690–6162.
SUPPLEMENTARY INFORMATION: When
submitting comments or requesting
information, please include the
document identifier HHS–OS–60D for
reference.
Information Collection Request Title:
Health Insurance Reform Security
Standards—Final Rule.
PO 00000
Frm 00036
Fmt 4703
Sfmt 4703
The final rule was published in the
Federal Register (68 FR 8334) as CMS–
0049–F published on February 20, 2003.
On May 22, 2013, CMS 0938–0949 was
transferred to OCR 0945–0004.
Abstract: Office of Civil Rights, OCR
requests approval to extend this
collection without change while OMB
reviews our request to incorporate the
burdens of compliance with the
Security Rule into another existing ICR
(OMB #0945–0003, for the HIPAA
Privacy Rule and Supporting
Regulations), which is being revised to
better reflect our experience in
administering and enforcing the HIPAA
Rules. This ICR extends the existing
approved information collection for
applicable compliance activities
associated with the HIPAA Security
Rule. When the revised ICR with OMB
#0945–0003 is approved, we will
request that this ICR (OMB# 0945–0004)
be discontinued.
Likely Respondents: HIPAA covered
entities and their business associates.
E:\FR\FM\15MRN1.SGM
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]]>Agencies
[Federal Register Volume 81, Number 50 (Tuesday, March 15, 2016)]
[Notices]
[Pages 13805-13806]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-05730]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration
Agency Information Collection Activities: Submission to OMB for
Review and Approval; Public Comment Request
AGENCY: Health Resources and Services Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: In compliance with Section 3507(a)(1)(D) of the Paperwork
Reduction Act of 1995, the Health Resources and Services Administration
(HRSA) has submitted an Information Collection Request (ICR) to the
Office of Management and Budget (OMB) for review and approval. Comments
submitted during the first public review of this ICR will be provided
to OMB. OMB will accept further comments from the public during the
review and approval period.
DATES: Comments on this ICR should be received no later than April 14,
2016.
ADDRESSES: Submit your comments, including the Information Collection
Request Title, to the desk officer for HRSA, either by email to
OIRA_submission@omb.eop.gov or by fax to 202-395-5806.
FOR FURTHER INFORMATION CONTACT: To request a copy of the clearance
requests submitted to OMB for review, email the HRSA Information
Collection Clearance Officer at paperwork@hrsa.gov or call (301) 443-
1984.
SUPPLEMENTARY INFORMATION:
Information Collection Request Title: Maternal and Child Health
Bureau Performance Measures for Discretionary Grants
OMB No.: 0915-0298--Revision
Abstract: The Maternal and Child Health Bureau's (MCHB)
Discretionary Grant Information System (DGIS) electronically captures
performance measure, program, financial, and abstract data, and
products and publications about these discretionary grants from the
grantees. The data collected are used by MCHB project officers to
monitor and assess grantee performance as well as assist in monitoring
and evaluating MCHB's programs.
Need and Proposed Use of the Information: The Health Resources and
Services Administration (HRSA) proposes to continue using reporting
requirements for grant programs administered by MCHB, including
national performance measures as previously approved by OMB, and in
accordance with the ``Government Performance and Results Act (GPRA) of
1993'' (Pub. L. 103-62). This Act requires the establishment of
measurable goals for Federal Programs that can be reported as part of
the budgetary process, thus linking funding decisions with performance.
Performance measures for MCHB discretionary grants were initially
approved in January 2003. Approval from OMB is being sought to continue
the use of performance measures for these grants. The revised
performance measures are categorized by population domains (Adolescent
Health, Child Health, Children with Special Health Care Needs,
Lifecourse/Crosscutting, Maternal/Women Health, and Perinatal/Infant
Health) consistent with Title V,
[[Page 13806]]
with the addition of a Capacity Building domain, specific to DGIS.
There are also program-specific measures included for a subset of
discretionary grant programs including the Healthy Start program,
Emergency Medical Services for Children program, and programs within
the Division of MCH Workforce Development. Grant programs will be
assigned measures in the domains that are appropriate for their
activities. Comments were received related to structure, content, and
volume of performance measures during the 60-day public comment period
and those comments were taken into consideration in the final revision
of the DGIS performance measures and overall DGIS data collection.
MCHB's purpose in revising the performance measures is to better
measure progress toward program goals. These program goals include
alignment with and support of the Title V Block Grant, specifically
population domains and National Performance Measures, where reasonable.
Further, the revised measures will more accurately capture the scope of
services provided through this grant funding. The overall number of
performance measures has been reduced from prior DGIS data collection,
and the average number of performance measures each grantee will be
required to report is reduced as well. Further, the structure of the
data collection has been revised to better measure the various models
of programs and the services each funded program provides. This
revision will allow a more accurate and detailed picture of the full
scope of services provided through grant programs administered by MCHB.
The data collected are also used by MCHB project officers to monitor
and assess grantee performance as well as assist in monitoring and
evaluating MCHB's programs.
Likely Respondents: Discretionary grant programs administered by
the Maternal and Child Health Bureau.
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 ICR are summarized in the table below.
Total Estimated Annualized Burden--Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of Average burden
Form name Number of responses per Total responses per response Total burden
respondents respondent (in hours) hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
Grant Report............................................. 600 1 600 36 21,600
----------------------------------------------------------------------------------------------
Total................................................ 600 1 600 36 21,600
--------------------------------------------------------------------------------------------------------------------------------------------------------
Jackie Painter,
Director, Division of the Executive Secretariat.
[FR Doc. 2016-05730 Filed 3-14-16; 8:45 am]
BILLING CODE 4165-15-P
