Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request, 13805-13806 [2016-05730]

Download as PDF 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 http:// www.regulations.gov. Submit both copies to the Division of Dockets Management. 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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 VerDate Sep<11>2014 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)) (http://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 (http:// 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 http://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: VerDate Sep<11>2014 17:40 Mar 14, 2016 Jkt 238001 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 15MRN1

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]


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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