81 FR 13805 - Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration Federal Register Volume 81, Issue 50 (March 15, 2016)
Health Resources and Services Administration
Federal Register Volume 81, Issue 50 (March 15, 2016)
| Page Range | 13805-13806 | |
| FR Document | 2016-05730 |
[Federal Register Volume 81, Number 50 (Tuesday, March 15, 2016)] [Notices] [Pages 13805-13806] From the Federal Register Online [www.thefederalregister.org] [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 [email protected] 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 [email protected] 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
![Federal Register / Vol. 81, No. 50 / Tuesday, March 15, 2016 / Notices 13805
submission. You should submit two September 2017. FDA uses these fees to Management and Budget (OMB) for
copies total. One copy will include the expedite the review process for review and approval. Comments
information you claim to be confidential biosimilar biological products. submitted during the first public review
with a heading or cover note that states Biosimilar biological products represent of this ICR will be provided to OMB.
‘‘THIS DOCUMENT CONTAINS an important public health benefit, with OMB will accept further comments from
CONFIDENTIAL INFORMATION.’’ The the potential to offer life-saving or life- the public during the review and
Agency will review this copy, including altering benefits at reduced cost to the approval period.
the claimed confidential information, in patient. BsUFA facilitates the DATES: Comments on this ICR should be
its consideration of comments. The development of safe and effective received no later than April 14, 2016.
second copy, which will have the biosimilar products for the American ADDRESSES: Submit your comments,
claimed confidential information public. including the Information Collection
redacted/blacked out, will be available As part of BsUFA, FDA is required to Request Title, to the desk officer for
for public viewing and posted on http:// contract with an independent HRSA, either by email to OIRA_
www.regulations.gov. Submit both accounting or consulting firm to study submission@omb.eop.gov or by fax to
copies to the Division of Dockets the workload volume and full costs 202–395–5806.
Management. If you do not wish your associated with the process for the FOR FURTHER INFORMATION CONTACT: To
name and contact information to be review of biosimilar biological product request a copy of the clearance requests
made publicly available, you can applications. This notice solicits submitted to OMB for review, email the
provide this information on the cover comments on the final report. The final HRSA Information Collection Clearance
sheet and not in the body of your report is described in section 744I(d) of Officer at paperwork@hrsa.gov or call
comments and you must identify this the FD&C Act (21 U.S.C. 379j–53(d)) (301) 443–1984.
information as ‘‘confidential.’’ Any (http://uscode.house.gov/
SUPPLEMENTARY INFORMATION:
information marked as ‘‘confidential’’ view.xhtml?req=granuleid:U.S.C.-
Information Collection Request Title:
will not be disclosed except in prelim-title21-section379j-
Maternal and Child Health Bureau
accordance with 21 CFR 10.20 and other 53&num=0&edition=prelim), as
Performance Measures for Discretionary
applicable disclosure law. For more amended by the Food and Drug
Grants
information about FDA’s posting of Administration Safety and Innovation OMB No.: 0915–0298—Revision
comments to public dockets, see 80 FR Act enacted in 2012 (http:// Abstract: The Maternal and Child
56469, September 18, 2015, or access www.gpo.gov/fdsys/pkg/PLAW- Health Bureau’s (MCHB) Discretionary
the information at: http://www.fda.gov/ 112publ144/pdf/PLAW- Grant Information System (DGIS)
regulatoryinformation/dockets/ 112publ144.pdf). (FDA has verified the electronically captures performance
default.htm. Web site addresses, as of the date this measure, program, financial, and
Docket: For access to the docket to document publishes in the Federal abstract data, and products and
read background documents or the Register, but Web sites are subject to publications about these discretionary
electronic and written/paper comments change over time.) grants from the grantees. The data
received, go to http:// II. Electronic Access collected are used by MCHB project
www.regulations.gov and insert the officers to monitor and assess grantee
docket number, found in brackets in the The final report can be accessed at
performance as well as assist in
heading of this document, into the http://www.fda.gov/ForIndustry/
monitoring and evaluating MCHB’s
‘‘Search’’ box and follow the prompts UserFees/BiosimilarUserFeeActBsUFA/
programs.
and/or go to the Division of Dockets ucm459682.htm.
Need and Proposed Use of the
Management, 5630 Fishers Lane, Rm. Dated: March 9, 2016. Information: The Health Resources and
1061, Rockville, MD 20852. Leslie Kux, Services Administration (HRSA)
FOR FURTHER INFORMATION CONTACT: Associate Commissioner for Policy. proposes to continue using reporting
Mark Ascione, Center for Drug [FR Doc. 2016–05720 Filed 3–14–16; 8:45 am] requirements for grant programs
Evaluation and Research, Food and BILLING CODE 4164–01–P administered by MCHB, including
Drug Administration, 10903 New national performance measures as
Hampshire Ave., Bldg. 51, Rm. 1150, previously approved by OMB, and in
Silver Spring, MD 20993–0002, 301– DEPARTMENT OF HEALTH AND accordance with the ‘‘Government
796–7652, FAX: 301–847–8443. HUMAN SERVICES Performance and Results Act (GPRA) of
SUPPLEMENTARY INFORMATION: 1993’’ (Pub. L. 103–62). This Act
Health Resources and Services requires the establishment of
I. Background Administration measurable goals for Federal Programs
The Patient Protection and Affordable that can be reported as part of the
Care Act of 2010 (Pub. L. 111–148) Agency Information Collection budgetary process, thus linking funding
amended the Public Health Service Act Activities: Submission to OMB for decisions with performance.
to create an abbreviated licensure Review and Approval; Public Comment Performance measures for MCHB
pathway for biological products that are Request discretionary grants were initially
demonstrated to be ‘‘biosimilar’’ to or AGENCY: Health Resources and Services approved in January 2003. Approval
‘‘interchangeable’’ with an FDA- from OMB is being sought to continue
asabaliauskas on DSK3SPTVN1PROD with NOTICES
Administration, HHS.
licensed biological product. The Federal ACTION: Notice. the use of performance measures for
Food, Drug, and Cosmetic Act (the these grants. The revised performance
FD&C Act), as amended by BsUFA (Title SUMMARY: In compliance with Section measures are categorized by population
IV of the Food and Drug Administration 3507(a)(1)(D) of the Paperwork domains (Adolescent Health, Child
Safety and Innovation Act, Pub. L. 112– Reduction Act of 1995, the Health Health, Children with Special Health
114), authorizes FDA to assess and Resources and Services Administration Care Needs, Lifecourse/Crosscutting,
collect fees for biosimilar biological (HRSA) has submitted an Information Maternal/Women Health, and Perinatal/
products from October 2012 through Collection Request (ICR) to the Office of Infant Health) consistent with Title V,
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![13806 Federal Register / Vol. 81, No. 50 / Tuesday, March 15, 2016 / Notices
with the addition of a Capacity Building Grant, specifically population domains Likely Respondents: Discretionary
domain, specific to DGIS. There are also and National Performance Measures, grant programs administered by the
program-specific measures included for where reasonable. Further, the revised Maternal and Child Health Bureau.
a subset of discretionary grant programs measures will more accurately capture Burden Statement: Burden in this
including the Healthy Start program, the scope of services provided through context means the time expended by
Emergency Medical Services for this grant funding. The overall number
persons to generate, maintain, retain,
Children program, and programs within of performance measures has been
disclose or provide the information
the Division of MCH Workforce reduced from prior DGIS data
Development. Grant programs will be collection, and the average number of requested. This includes the time
assigned measures in the domains that performance measures each grantee will needed to review instructions; to
are appropriate for their activities. be required to report is reduced as well. develop, acquire, install and utilize
Comments were received related to Further, the structure of the data technology and systems for the purpose
structure, content, and volume of collection has been revised to better of collecting, validating and verifying
performance measures during the 60- measure the various models of programs information, processing and
day public comment period and those and the services each funded program maintaining information, and disclosing
comments were taken into consideration provides. This revision will allow a and providing information; to train
in the final revision of the DGIS more accurate and detailed picture of personnel and to be able to respond to
performance measures and overall DGIS the full scope of services provided a collection of information; to search
data collection. through grant programs administered by data sources; to complete and review
MCHB’s purpose in revising the MCHB. The data collected are also used the collection of information; and to
performance measures is to better by MCHB project officers to monitor and transmit or otherwise disclose the
measure progress toward program goals. assess grantee performance as well as information. The total annual burden
These program goals include alignment assist in monitoring and evaluating hours estimated for this ICR are
with and support of the Title V Block MCHB’s programs. summarized in the table below.
TOTAL ESTIMATED ANNUALIZED BURDEN—HOURS
Average
Number of
Number of burden per Total burden
Form name responses per Total responses
respondents response hours
respondent (in hours)
Grant Report .......................................... 600 1 600 36 21,600
Total ................................................ 600 1 600 36 21,600
Jackie Painter, Office of Management and Budget The final rule was published in the
Director, Division of the Executive Secretariat. (OMB). The ICR is for extending the use Federal Register (68 FR 8334) as CMS–
[FR Doc. 2016–05730 Filed 3–14–16; 8:45 am] of the approved information collection 0049–F published on February 20, 2003.
BILLING CODE 4165–15–P assigned OMB control number 0945– On May 22, 2013, CMS 0938–0949 was
0004, which expires on May 31, 2016. transferred to OCR 0945–0004.
Prior to submitting the ICR to OMB, OS Abstract: Office of Civil Rights, OCR
DEPARTMENT OF HEALTH AND seeks comments from the public requests approval to extend this
HUMAN SERVICES regarding the burden estimate, below, or collection without change while OMB
any other aspect of the ICR. reviews our request to incorporate the
Office of the Secretary DATES: Comments on the ICR must be burdens of compliance with the
[Document Identifier: HHS–OS–0945–0004 received on or before May 16, 2016. Security Rule into another existing ICR
60D] ADDRESSES: Submit your comments to (OMB #0945–0003, for the HIPAA
Information.CollectionClearance@ Privacy Rule and Supporting
Agency Information Collection hhs.gov or by calling (202) 690–6162. Regulations), which is being revised to
Activities; Proposed Collection; Public FOR FURTHER INFORMATION CONTACT: better reflect our experience in
Comment Request Information Collection Clearance staff, administering and enforcing the HIPAA
AGENCY: Office of the Secretary, HHS. Information.CollectionClearance@ Rules. This ICR extends the existing
hhs.gov or (202) 690–6162. approved information collection for
ACTION: Notice.
SUPPLEMENTARY INFORMATION: When applicable compliance activities
SUMMARY: In compliance with section submitting comments or requesting associated with the HIPAA Security
3506(c)(2)(A) of the Paperwork information, please include the Rule. When the revised ICR with OMB
Reduction Act of 1995, the Office of the document identifier HHS–OS–60D for #0945–0003 is approved, we will
Secretary (OS), Department of Health reference. request that this ICR (OMB# 0945–0004)
and Human Services, announces plans Information Collection Request Title: be discontinued.
asabaliauskas on DSK3SPTVN1PROD with NOTICES
to submit an Information Collection Health Insurance Reform Security Likely Respondents: HIPAA covered
Request (ICR), described below, to the Standards—Final Rule. entities and their business associates.
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Document Created: 2016-03-15 04:06:43
Document Modified: 2016-03-15 04:06:43
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice. | |
| Dates | Comments on this ICR should be received no later than April 14, 2016. | |
| Contact | To request a copy of the clearance requests submitted to OMB for review, email the HRSA Information Collection Clearance Officer at [email protected] or call (301) 443- 1984. | |
| FR Citation | 81 FR 13805 |
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