83 FR 45246 - Proposed Data Collection Submitted for Public Comment and Recommendations
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention Federal Register Volume 83, Issue 173 (September 6, 2018)
Centers for Disease Control and Prevention
Federal Register Volume 83, Issue 173 (September 6, 2018)
| Page Range | 45246-45247 | |
| FR Document | 2018-19294 |
[Federal Register Volume 83, Number 173 (Thursday, September 6, 2018)] [Notices] [Pages 45246-45247] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-19294] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention [60Day-18-18AVU; Docket No. CDC-2018-0081] Proposed Data Collection Submitted for Public Comment and Recommendations AGENCY: Centers for Disease Control and Prevention (CDC), Department of Health and Human Services (HHS). ACTION: Notice with comment period. ----------------------------------------------------------------------- SUMMARY: The Centers for Disease Control and Prevention (CDC), as part of its continuing efforts to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies to take this opportunity to comment on a proposed and/ or continuing information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection project titled ``Assessment of Outcomes Associated with the Preventive Health and Health Services Block Grant''. This assessment will assess select cross-cutting outputs and outcomes of the Preventive Health and Health Services Block Grant and demonstrates the utility of the grant on a national level. DATES: CDC must receive written comments on or before November 5, 2018. ADDRESSES: You may submit comments, identified by Docket No. CDC-2018- 0081 by any of the following methods:Federal eRulemaking Portal: Regulations.gov. Follow the instructions for submitting comments. Mail: Jeffrey M. Zirger, Information Collection Review Office, Centers for Disease Control and Prevention, 1600 Clifton Road NE, MS-D74, Atlanta, Georgia 30329. Instructions: All submissions received must include the agency name and Docket Number. CDC will post, without change, all relevant comments to Regulations.gov. Please note: Submit all comments through the Federal eRulemaking portal (regulations.gov) or by U.S. mail to the address listed above. FOR FURTHER INFORMATION CONTACT: To request more information on the proposed project or to obtain a copy of the information collection plan and instruments, contact Jeffery M. Zirger, Information Collection Review Office, Centers for Disease Control and Prevention, 1600 Clifton Road NE, MS-D74, Atlanta, Georgia 30329; phone: 404-639-7570; Email: omb@cdc.gov. SUPPLEMENTARY INFORMATION: Under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3520), Federal agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. In addition, the PRA also requires Federal agencies to provide a 60-day notice in the Federal Register concerning each proposed collection of information, including each new proposed collection, each proposed extension of existing collection of information, and each reinstatement of previously approved information collection before submitting the collection to OMB for approval. To comply with this requirement, we are publishing this notice of a proposed data collection as described below. The OMB is particularly interested in comments that will help: 1. Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility; 2. Evaluate the accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; 3. Enhance the quality, utility, and clarity of the information to be collected; and 4. Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g., permitting electronic submissions of responses. 5. Assess information collection costs. Proposed Project Assessment of Outcomes Associated with the Preventive Health and Health Services Block Grant--New--Office for State, Tribal, Local and Territorial Support (OSTLTS), Centers for Disease Control and Prevention (CDC). Background and Brief Description For more than 35 years, the Preventive Health and Health Services Block Grant (PHHS Block Grant) has provided flexible funding for all 50 states, the District of Columbia, two American Indian tribes, five U.S. territories, and three freely associated states to address the unique public health needs of their jurisdictions in innovative and locally defined ways. First authorized by Congress in 1981 through the Public Health Service Act (Pub. L. 102-531), the fundamental and enduring purpose of the grant has been to provide grantees with flexibility and control to address their priority public health needs. In 1992, Congress amended the law to align PHHS Block Grant funding priorities with the 22 chapters specified in Healthy People (HP) 2000, a set of national objectives designed to guide health promotion and disease prevention efforts. Additional amendments included set-aside funds specifically dedicated to sex offense prevention and victim services, thus requiring grantees receiving this support to include related HP objectives and activities as part of their PHHS Block Grant-funded local programs. CDC is establishing a comprehensive, standardized method to collect data to describe select outputs and outcomes and ensure the accountability of the PHHS Block Grant. The CDC PHHS Block Grant Measurement Framework is an innovative approach to assessing cross- cutting outputs and outcomes resulting from grantees' use of flexible grant funds. The framework defines four measures that enable CDC to standardize the collection of data on grantee achievements. The measures capture data on public health infrastructure improved (i.e., information systems improved and quality improved--efficiency and effectiveness improvements achieved in programs, services, and operations), emerging public health needs addressed, and evidence-based public health interventions implemented. The purpose of this information collection request (ICR) is to collect data that assess select cross-cutting outputs and outcomes of the grant (as defined by the framework measures) and that demonstrate the utility of the grant on a national level. This data collection will describe the outcomes of the PHHS Block Grant as a whole--not individual grantee activities or outcomes. Findings from this data collection will be used to: (1) Describe the outcomes and achievements of grantees' public health efforts and identify how the use of PHHS Block Grant funds contributed to [[Page 45247]] those results, and (2) help assess how the PHHS Block Grant advances work of the public health system and provides evidence to support future budgetary requests. The respondent universe consists of 61 PHHS Block Grant coordinators, or their designees, across 61 health departments (50 states, the District of Columbia, two tribes, five US territories, and three freely associated states). The assessment will be administered to PHHS Block Grant coordinators electronically via a web-based questionnaire. A link to the assessment will be provided by email invitation. The survey will be completed once every two years. The total annualized estimated burden is 46 hours. Estimated Annualized Burden Hours ---------------------------------------------------------------------------------------------------------------- Number of Average burden Type of respondents Form name Number of responses per per response Total burden respondents respondent (in hours) (in hours) ---------------------------------------------------------------------------------------------------------------- PHHS Block Grant Coordinators, PHHS Block Grant 61 1 45/60 46 or Designees. Assessment. --------------------------------------------------------------- Total..................... ................ .............. .............. .............. 46 ---------------------------------------------------------------------------------------------------------------- Jeffrey M. Zirger, Acting Chief, Information Collection Review Office, Office of Scientific Integrity, Office of the Associate Director for Science, Office of the Director, Centers for Disease Control and Prevention. [FR Doc. 2018-19294 Filed 9-5-18; 8:45 am] BILLING CODE 4163-18-P
![45246 Federal Register / Vol. 83, No. 173 / Thursday, September 6, 2018 / Notices
Jeffrey M. Zirger, (regulations.gov) or by U.S. mail to the Background and Brief Description
Acting Chief, Information Collection Review address listed above. For more than 35 years, the
Office, Office of Scientific Integrity, Office
FOR FURTHER INFORMATION CONTACT: To Preventive Health and Health Services
of the Associate Director for Science, Office
of the Director, Centers for Disease Control request more information on the Block Grant (PHHS Block Grant) has
and Prevention. proposed project or to obtain a copy of provided flexible funding for all 50
[FR Doc. 2018–19296 Filed 9–5–18; 8:45 am] the information collection plan and states, the District of Columbia, two
instruments, contact Jeffery M. Zirger, American Indian tribes, five U.S.
BILLING CODE 4163–18–P
Information Collection Review Office, territories, and three freely associated
Centers for Disease Control and states to address the unique public
DEPARTMENT OF HEALTH AND Prevention, 1600 Clifton Road NE, MS– health needs of their jurisdictions in
HUMAN SERVICES D74, Atlanta, Georgia 30329; phone: innovative and locally defined ways.
404–639–7570; Email: omb@cdc.gov. First authorized by Congress in 1981
Centers for Disease Control and through the Public Health Service Act
SUPPLEMENTARY INFORMATION: Under the
Prevention (Pub. L. 102–531), the fundamental and
Paperwork Reduction Act of 1995 (PRA)
enduring purpose of the grant has been
[60Day–18–18AVU; Docket No. CDC–2018– (44 U.S.C. 3501–3520), Federal agencies
to provide grantees with flexibility and
0081] must obtain approval from the Office of
control to address their priority public
Management and Budget (OMB) for each
Proposed Data Collection Submitted health needs. In 1992, Congress
collection of information they conduct
for Public Comment and amended the law to align PHHS Block
or sponsor. In addition, the PRA also
Recommendations Grant funding priorities with the 22
requires Federal agencies to provide a
chapters specified in Healthy People
AGENCY: Centers for Disease Control and 60-day notice in the Federal Register
(HP) 2000, a set of national objectives
Prevention (CDC), Department of Health concerning each proposed collection of
designed to guide health promotion and
and Human Services (HHS). information, including each new
disease prevention efforts. Additional
ACTION: Notice with comment period.
proposed collection, each proposed
amendments included set-aside funds
extension of existing collection of
specifically dedicated to sex offense
SUMMARY: The Centers for Disease information, and each reinstatement of
prevention and victim services, thus
Control and Prevention (CDC), as part of previously approved information
requiring grantees receiving this support
its continuing efforts to reduce public collection before submitting the
to include related HP objectives and
burden and maximize the utility of collection to OMB for approval. To
activities as part of their PHHS Block
government information, invites the comply with this requirement, we are
Grant-funded local programs.
general public and other Federal publishing this notice of a proposed CDC is establishing a comprehensive,
agencies to take this opportunity to data collection as described below. standardized method to collect data to
comment on a proposed and/or The OMB is particularly interested in describe select outputs and outcomes
continuing information collection, as comments that will help: and ensure the accountability of the
required by the Paperwork Reduction 1. Evaluate whether the proposed PHHS Block Grant. The CDC PHHS
Act of 1995. This notice invites collection of information is necessary Block Grant Measurement Framework is
comment on a proposed information for the proper performance of the an innovative approach to assessing
collection project titled ‘‘Assessment of functions of the agency, including cross-cutting outputs and outcomes
Outcomes Associated with the whether the information will have resulting from grantees’ use of flexible
Preventive Health and Health Services practical utility; grant funds. The framework defines four
Block Grant’’. This assessment will measures that enable CDC to
2. Evaluate the accuracy of the
assess select cross-cutting outputs and standardize the collection of data on
agency’s estimate of the burden of the
outcomes of the Preventive Health and grantee achievements. The measures
proposed collection of information,
Health Services Block Grant and capture data on public health
including the validity of the
demonstrates the utility of the grant on infrastructure improved (i.e.,
methodology and assumptions used;
a national level. information systems improved and
DATES: CDC must receive written
3. Enhance the quality, utility, and
clarity of the information to be quality improved—efficiency and
comments on or before November 5, effectiveness improvements achieved in
2018. collected; and
programs, services, and operations),
4. Minimize the burden of the emerging public health needs
ADDRESSES: You may submit comments,
collection of information on those who addressed, and evidence-based public
identified by Docket No. CDC–2018–
are to respond, including through the health interventions implemented.
0081 by any of the following methods:
use of appropriate automated,
• Federal eRulemaking Portal: The purpose of this information
electronic, mechanical, or other collection request (ICR) is to collect data
Regulations.gov. Follow the instructions
technological collection techniques or that assess select cross-cutting outputs
for submitting comments.
• Mail: Jeffrey M. Zirger, Information other forms of information technology, and outcomes of the grant (as defined by
Collection Review Office, Centers for e.g., permitting electronic submissions the framework measures) and that
Disease Control and Prevention, 1600 of responses. demonstrate the utility of the grant on
Clifton Road NE, MS–D74, Atlanta, 5. Assess information collection costs. a national level. This data collection
Georgia 30329. Proposed Project will describe the outcomes of the PHHS
daltland on DSKBBV9HB2PROD with NOTICES
Instructions: All submissions received Block Grant as a whole—not individual
must include the agency name and Assessment of Outcomes Associated grantee activities or outcomes. Findings
Docket Number. CDC will post, without with the Preventive Health and Health from this data collection will be used to:
change, all relevant comments to Services Block Grant—New—Office for (1) Describe the outcomes and
Regulations.gov. State, Tribal, Local and Territorial achievements of grantees’ public health
Please note: Submit all comments Support (OSTLTS), Centers for Disease efforts and identify how the use of
through the Federal eRulemaking portal Control and Prevention (CDC). PHHS Block Grant funds contributed to
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![Federal Register / Vol. 83, No. 173 / Thursday, September 6, 2018 / Notices 45247
those results, and (2) help assess how their designees, across 61 health electronically via a web-based
the PHHS Block Grant advances work of departments (50 states, the District of questionnaire. A link to the assessment
the public health system and provides Columbia, two tribes, five US territories, will be provided by email invitation.
evidence to support future budgetary and three freely associated states). The The survey will be completed once
requests. assessment will be administered to every two years. The total annualized
The respondent universe consists of PHHS Block Grant coordinators estimated burden is 46 hours.
61 PHHS Block Grant coordinators, or
ESTIMATED ANNUALIZED BURDEN HOURS
Average
Number of Total
Number of burden per
Type of respondents Form name responses per burden
respondents response
respondent (in hours)
(in hours)
PHHS Block Grant Coordinators, or PHHS Block Grant Assessment ...... 61 1 45/60 46
Designees.
Total ........................................... ........................................................... ........................ ........................ ........................ 46
Jeffrey M. Zirger, greater predictability, consistency, and do not wish to be made available to the
Acting Chief, Information Collection Review efficiency through the application of public, submit the comment as a
Office, Office of Scientific Integrity, Office least burdensome principles. This draft written/paper submission and in the
of the Associate Director for Science, Office guidance also provides examples of how manner detailed (see ‘‘Written/Paper
of the Director, Centers for Disease Control the principles for considering Submissions’’ and ‘‘Instructions’’).
and Prevention.
uncertainty could be applied in the
[FR Doc. 2018–19294 Filed 9–5–18; 8:45 am] context of clinical evidence and Written/Paper Submissions
BILLING CODE 4163–18–P circumstances where greater uncertainty Submit written/paper submissions as
could be appropriate in premarket follows:
decisions, balanced by postmarket • Mail/Hand delivery/Courier (for
DEPARTMENT OF HEALTH AND controls—PMAs for Breakthrough written/paper submissions): Dockets
HUMAN SERVICES Devices and PMAs for devices for small Management Staff (HFA–305), Food and
patient populations. This draft guidance Drug Administration, 5630 Fishers
Food and Drug Administration Lane, Rm. 1061, Rockville, MD 20852.
is not final nor is it in effect at this time.
[Docket No. FDA–2018–D–3130] DATES: Submit either electronic or • For written/paper comments
written comments on the draft guidance submitted to the Dockets Management
Consideration of Uncertainty in Making Staff, FDA will post your comment, as
by December 5, 2018 to ensure that the
Benefit-Risk Determinations in Medical well as any attachments, except for
Agency considers your comment on this
Device Premarket Approvals, De Novo information submitted, marked and
draft guidance before it begins work on
Classifications, and Humanitarian identified, as confidential, if submitted
the final version of the guidance.
Device Exemptions; Draft Guidance for as detailed in ‘‘Instructions.’’
ADDRESSES: You may submit comments
Industry and Food and Drug Instructions: All submissions received
Administration Staff; Availability on any guidance at any time as follows:
must include the Docket No. FDA–
Electronic Submissions 2018–D–3130 for ‘‘Consideration of
AGENCY: Food and Drug Administration,
HHS. Submit electronic comments in the Uncertainty in Making Benefit-Risk
following way: Determinations in Medical Device
ACTION: Notice of availability.
• Federal eRulemaking Portal: Premarket Approvals, De Novo
SUMMARY: The Food and Drug https://www.regulations.gov. Follow the Classifications, and Humanitarian
Administration (FDA or Agency) is instructions for submitting comments. Device Exemptions; Draft Guidance for
announcing the availability of the draft Comments submitted electronically, Industry and Food and Drug
guidance entitled ‘‘Consideration of including attachments, to https:// Administration Staff.’’ Received
Uncertainty in Making Benefit-Risk www.regulations.gov will be posted to comments will be placed in the docket
Determinations in Medical Device the docket unchanged. Because your and, except for those submitted as
Premarket Approvals, De Novo comment will be made public, you are ‘‘Confidential Submissions,’’ publicly
Classifications, and Humanitarian solely responsible for ensuring that your viewable at https://www.regulations.gov
Device Exemptions.’’ This guidance comment does not include any or at the Dockets Management Staff
document describes FDA’s current confidential information that you or a between 9 a.m. and 4 p.m., Monday
approach to considering uncertainty in third party may not wish to be posted, through Friday.
making benefit-risk determinations to such as medical information, your or • Confidential Submissions—To
support certain FDA premarket anyone else’s Social Security number, or submit a comment with confidential
decisions for medical devices— confidential business information, such information that you do not wish to be
premarket approval applications as a manufacturing process. Please note made publicly available, submit your
daltland on DSKBBV9HB2PROD with NOTICES
(PMAs), De Novo requests, and that if you include your name, contact comments only as a written/paper
humanitarian device exemption (HDE) information, or other information that submission. You should submit two
applications. This guidance document identifies you in the body of your copies total. One copy will include the
elaborates on the consideration of comments, that information will be information you claim to be confidential
uncertainty as part of our overarching posted on https://www.regulations.gov. with a heading or cover note that states
approach to a benefit-risk based • If you want to submit a comment ‘‘THIS DOCUMENT CONTAINS
framework that is intended to assure with confidential information that you CONFIDENTIAL INFORMATION.’’ The
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Document Created: 2018-09-05 23:56:38
Document Modified: 2018-09-05 23:56:38
| 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 with comment period. | |
| Dates | CDC must receive written comments on or before November 5, 2018. | |
| Contact | To request more information on the proposed project or to obtain a copy of the information collection plan and instruments, contact Jeffery M. Zirger, Information Collection Review Office, Centers for Disease Control and Prevention, 1600 Clifton Road NE, MS-D74, Atlanta, Georgia 30329; phone: 404-639-7570; Email: [email protected] | |
| FR Citation | 83 FR 45246 |
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