81 FR 26237 - Agency Information Collection Activities; Proposed Collection; Public Comment Request
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Office of the Assistant Secretary for Health Federal Register Volume 81, Issue 84 (May 2, 2016)
Office of the Assistant Secretary for Health
Federal Register Volume 81, Issue 84 (May 2, 2016)
| Page Range | 26237-26238 | |
| FR Document | 2016-10199 |
[Federal Register Volume 81, Number 84 (Monday, May 2, 2016)] [Notices] [Pages 26237-26238] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-10199] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Office of the Assistant Secretary for Health [Document Identifier: HHS-OS-0990-New-60D] Agency Information Collection Activities; Proposed Collection; Public Comment Request ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: In compliance with section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, the Office of the Assistant Secretary for Health (OASH), Department of Health and Human Services, announces plans to submit a new Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB). Prior to submitting the ICR to OMB, OASH seeks comments from the public [[Page 26238]] regarding the burden estimate, below, or any other aspect of the ICR. DATES: Comments on the ICR must be received on or before July 1, 2016. ADDRESSES: Submit your comments to [email protected] or by calling (202) 690-6162. FOR FURTHER INFORMATION CONTACT: Information Collection Clearance staff, [email protected] or (202) 690-6162. SUPPLEMENTARY INFORMATION: When submitting comments or requesting information, please include the document identifier HHS-OS-0990-New-- 60D for reference. Information Collection Request Title: Evaluation of the Second Decade Project Community Planning Guide Abstract: The Office of the Assistant Secretary for Health (OASH) is requesting approval from the Office of Management and Budget (OMB) for an evaluation of the Second Decade Project Community Planning Guide. OASH has a long history of collaborating with communities to improve adolescent health outcomes. To further help communities build an environment that promotes adolescent health, OASH recently developed Promoting Health and Healthy Development in the Second Decade of Life: A Planning Guide for Communities (``the Guide''). The purpose of the Guide is to provide an easy to follow tool that community leaders can use to (1) establish a community coalition with broad membership, and (2) develop a community plan for improving adolescent health and well- being that includes multi-impact strategies. To understand whether and how community leaders are able to use the Guide to achieve these two goals, OASH needs information about the Guide's utility and effectiveness. The evaluation of the Second Decade Project Community Planning Guide (``the evaluation'') is intended to support the goals of OASH's Second Decade Project of helping community leaders incorporate the needs of children, adolescents and young adults in community growth and development plans, and to improve outcomes of young adults and adolescents. Five communities will participate in the piloting and evaluation of the Guide. The evaluation will provide OASH with critical information regarding the components of the Guide that community leaders found most useful and effective in accomplishing their goals of improving adolescent health and wellbeing; the compilation and inclusiveness of the coalitions implementing the Guide; and the demographic and environmental context of these communities. While secondary data will be collected from sources such as the U.S. Census Bureau American Community Survey and Youth Risk Behavior and National Health Interview Surveys, these sources do not provide nuanced information needed by OASH to understand the contexts in which the Guide is most effective. Likely Respondents--Qualitative data will be collected through semi-structured telephone interviews and through focus groups. Telephone interviews will be conducted with community leaders (Community Leader Interview) in the five pilot sites to explore how the use of the Guide supported key leaders in their development of a diverse coalition and educating the community about issues facing adolescents. Focus groups will be conducted with coalition members (Coalition Member Focus Groups) from the five pilot sites to assess how the Guide facilitated the work of the coalition to develop a comprehensive community plan that addresses critically important adolescent health issues. Quantitative data will be collected through Web-based surveys with coalition members from the five communities and with secondary stakeholders--specifically, adolescent health experts and state/local health department officials--selected by OASH. The Coalition Assessment Survey will assess coalition members' perspectives on the usefulness and ease of implementing the Guide. The Secondary Stakeholder Survey will engage Adolescent Health researchers and practitioners to garner additional feedback and assessment of the Guide. Total Estimated Annualized Burden--Hours ---------------------------------------------------------------------------------------------------------------- Number of Form name Number of responses per Hours per Total burden respondents respondent response hours ---------------------------------------------------------------------------------------------------------------- Community Leader Interview (CLI)............... 50 1 1 50 Coalition Member Focus Group (CFG)............. 80 1 1 80 Coalition Assessment Survey (CAS).............. 250 1 .25 63 Secondary Stakeholder Survey (SSS)............. 50 1 .5 25 ---------------------------------------------------------------- Total...................................... 430 ............... .............. 218 ---------------------------------------------------------------------------------------------------------------- OASH specifically requests comments on (1) the necessity and utility of the proposed information collection for the proper performance of the agency's functions, (2) the accuracy of the estimated burden, (3) ways to enhance the quality, utility, and clarity of the information to be collected, and (4) the use of automated collection techniques or other forms of information technology to minimize the information collection burden. Terry S. Clark, Asst. Information Collection Clearance Officer. [FR Doc. 2016-10199 Filed 4-29-16; 8:45 am] BILLING CODE 4150-28-P
![Federal Register / Vol. 81, No. 84 / Monday, May 2, 2016 / Notices 26237
Management between 9 a.m. and 4 p.m., 5900; email: William.Burkholder@ determining whether to take regulatory
Monday through Friday. fda.hhs.gov. action against an article of dog or cat
• Confidential Submissions—To SUPPLEMENTARY INFORMATION: food does not impose collection of
submit a comment with confidential information burdens on the public. In
information that you do not wish to be I. Background addition, to the extent that we obtain
made publicly available, submit your In the Federal Register of September information during an enforcement
comments only as a written/paper 10, 2012 (77 FR 55480), FDA published action, this collection is exempt from
submission. You should submit two the notice of availability for a draft CPG OMB review under 44 U.S.C.
copies total. One copy will include the entitled ‘‘Compliance Policy Guide Sec. 3518(c)(1)(B) and 5 CFR 1320.4(a)(2) as
information you claim to be confidential 690.150 Labeling and Marketing of collection of information obtained
with a heading or cover note that states Nutritional Products Intended for Use to during the conduct of a civil action to
‘‘THIS DOCUMENT CONTAINS Diagnose, Cure, Mitigate, Treat, or which the United States or any official
CONFIDENTIAL INFORMATION.’’ The Prevent Disease in Dogs and Cats’’ or agency thereof is a party, or during
Agency will review this copy, including giving interested persons until the conduct of an administrative action,
the claimed confidential information, in November 9, 2012, to comment on the investigation, or audit involving an
its consideration of comments. The draft CPG. FDA received several agency against specific individuals or
second copy, which will have the comments on the draft CPG and those entities. The regulations in 5 CFR
claimed confidential information comments were considered as the CPG 1320(c) provide that the exception in 5
redacted/blacked out, will be available was finalized. CFR 1320.4(a)(2) applies during the
for public viewing and posted on FDA revised the title of the final CPG. entire course of the investigation, audit,
http://www.regulations.gov. Submit The final CPG is entitled ‘‘Compliance or action, but only after a case file or
both copies to the Division of Dockets Policy Guide Sec. 690.150 Labeling and equivalent is opened with respect to a
Management. If you do not wish your Marketing of Dog and Cat Food Diets particular party. Such a case file would
name and contact information to be Intended to Diagnose, Cure, Mitigate, be opened, for example, as part of the
made publicly available, you can Treat, or Prevent Diseases.’’ In addition decision to detain a drug or an article of
provide this information on the cover to revising the title, editorial changes food.
sheet and not in the body of your were made to improve clarity.
The CPG announced in this notice IV. Electronic Access
comments and you must identify this
finalizes the draft CPG dated September Persons with access to the Internet
information as ‘‘confidential.’’ Any
10, 2012. may obtain the CPG at either http://
information marked as ‘‘confidential’’
will not be disclosed except in II. Significance of Guidance www.fda.gov/ICECI/
accordance with 21 CFR 10.20 and other ComplianceManuals/
This level 1 CPG is being issued CompliancePolicyGuidanceManual/
applicable disclosure law. For more consistent with FDA’s good guidance
information about FDA’s posting of default.htm under ‘‘Compliance Policy
practices regulation (21 CFR 10.115). Guides’’ or http://www.regulations.gov.
comments to public dockets, see 80 FR The guidance represents the current
56469, September 18, 2015, or access thinking of FDA on labeling and Dated: April 25, 2016.
the information at: http://www.fda.gov/ marketing of dog and cat food diets Katherine Bent,
regulatoryinformation/dockets/ intended to diagnose, cure, mitigate, Assistant Commissioner for Compliance
default.htm. treat, or prevent diseases. It does not Policy.
Docket: For access to the docket to establish any rights for any person and [FR Doc. 2016–10234 Filed 4–29–16; 8:45 am]
read background documents or the is not binding on FDA or the public. BILLING CODE 4164–01–P
electronic and written/paper comments You can use an alternative approach if
received, go to http:// it satisfies the requirements of the
www.regulations.gov and insert the applicable statutes and regulations. DEPARTMENT OF HEALTH AND
docket number, found in brackets in the HUMAN SERVICES
III. Paperwork Reduction Act of 1995
heading of this document, into the
‘‘Search’’ box and follow the prompts Under the Paperwork Reduction Act Office of the Assistant Secretary for
and/or go to the Division of Dockets of 1995 (the PRA) (44 U.S.C. 3501– Health
Management, 5630 Fishers Lane, Rm. 3520), Federal Agencies must obtain
approval from the Office of Management [Document Identifier: HHS–OS–0990–New–
1061, Rockville, MD 20852.
and Budget (OMB) for each collection of 60D]
Submit written requests for single
copies of the guidance to the Policy and information they conduct or sponsor.
Agency Information Collection
Regulations Staff (HFV–6), Center for ‘‘Collection of information’’ is defined
Activities; Proposed Collection; Public
Veterinary Medicine, Food and Drug in 44 U.S.C. 3502(3) and 5 CFR 1320.3
Comment Request
Administration, 7519 Standish Pl., and includes Agency requests or
Rockville, MD 20855. Send one self- requirements that members of the public ACTION: Notice.
addressed adhesive label to assist that submit reports, keep records, or provide
office in processing your requests. See information to a third party. In the SUMMARY: In compliance with section
the SUPPLEMENTARY INFORMATION section Federal Register of September 10, 2012 3506(c)(2)(A) of the Paperwork
for electronic access to the guidance (77 FR 55480), FDA published a notice Reduction Act of 1995, the Office of the
announcing the availability of the draft Assistant Secretary for Health (OASH),
srobinson on DSK5SPTVN1PROD with NOTICES
document.
CPG. This document contained a Department of Health and Human
FOR FURTHER INFORMATION CONTACT: Paperwork Reduction Act burden Services, announces plans to submit a
William J. Burkholder, Center for analysis and requested comments on a new Information Collection Request
Veterinary Medicine, Division of proposed collection of information (77 (ICR), described below, to the Office of
Animal Feeds (HFV–220), Food and FR 55480 at 55481). We have concluded Management and Budget (OMB). Prior
Drug Administration, 7519 Standish that our guidance to FDA staff with to submitting the ICR to OMB, OASH
Place, Rockville, MD 20855, 240–402– respect to factors to consider when seeks comments from the public
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![26238 Federal Register / Vol. 81, No. 84 / Monday, May 2, 2016 / Notices
regarding the burden estimate, below, or broad membership, and (2) develop a to understand the contexts in which the
any other aspect of the ICR. community plan for improving Guide is most effective.
DATES: Comments on the ICR must be adolescent health and well-being that Likely Respondents—Qualitative data
received on or before July 1, 2016. includes multi-impact strategies. To will be collected through semi-
ADDRESSES: Submit your comments to understand whether and how structured telephone interviews and
Information.CollectionClearance@ community leaders are able to use the through focus groups. Telephone
hhs.gov or by calling (202) 690–6162. Guide to achieve these two goals, OASH interviews will be conducted with
FOR FURTHER INFORMATION CONTACT: needs information about the Guide’s community leaders (Community Leader
Information Collection Clearance staff, utility and effectiveness. The evaluation Interview) in the five pilot sites to
Information.CollectionClearance@ of the Second Decade Project explore how the use of the Guide
hhs.gov or (202) 690–6162. Community Planning Guide (‘‘the supported key leaders in their
SUPPLEMENTARY INFORMATION: When evaluation’’) is intended to support the development of a diverse coalition and
submitting comments or requesting goals of OASH’s Second Decade Project educating the community about issues
information, please include the of helping community leaders
facing adolescents. Focus groups will be
document identifier HHS–OS–0990– incorporate the needs of children,
conducted with coalition members
New—60D for reference. adolescents and young adults in
(Coalition Member Focus Groups) from
Information Collection Request Title: community growth and development
the five pilot sites to assess how the
Evaluation of the Second Decade Project plans, and to improve outcomes of
Guide facilitated the work of the
Community Planning Guide Abstract: young adults and adolescents. Five
coalition to develop a comprehensive
The Office of the Assistant Secretary for communities will participate in the
community plan that addresses
Health (OASH) is requesting approval piloting and evaluation of the Guide.
critically important adolescent health
from the Office of Management and The evaluation will provide OASH with
issues.
Budget (OMB) for an evaluation of the critical information regarding the
Second Decade Project Community components of the Guide that Quantitative data will be collected
Planning Guide. community leaders found most useful through Web-based surveys with
OASH has a long history of and effective in accomplishing their coalition members from the five
collaborating with communities to goals of improving adolescent health communities and with secondary
improve adolescent health outcomes. To and wellbeing; the compilation and stakeholders—specifically, adolescent
further help communities build an inclusiveness of the coalitions health experts and state/local health
environment that promotes adolescent implementing the Guide; and the department officials—selected by
health, OASH recently developed demographic and environmental context OASH. The Coalition Assessment
Promoting Health and Healthy of these communities. While secondary Survey will assess coalition members’
Development in the Second Decade of data will be collected from sources such perspectives on the usefulness and ease
Life: A Planning Guide for Communities as the U.S. Census Bureau American of implementing the Guide. The
(‘‘the Guide’’). The purpose of the Guide Community Survey and Youth Risk Secondary Stakeholder Survey will
is to provide an easy to follow tool that Behavior and National Health Interview engage Adolescent Health researchers
community leaders can use to (1) Surveys, these sources do not provide and practitioners to garner additional
establish a community coalition with nuanced information needed by OASH feedback and assessment of the Guide.
TOTAL ESTIMATED ANNUALIZED BURDEN—HOURS
Number of
Number of Hours per Total burden
Form name responses per
respondents response hours
respondent
Community Leader Interview (CLI) ................................................................ 50 1 1 50
Coalition Member Focus Group (CFG) ......................................................... 80 1 1 80
Coalition Assessment Survey (CAS) ............................................................. 250 1 .25 63
Secondary Stakeholder Survey (SSS) .......................................................... 50 1 .5 25
Total ........................................................................................................ 430 .......................... ........................ 218
OASH specifically requests comments technology to minimize the information DEPARTMENT OF HEALTH AND
on (1) the necessity and utility of the collection burden. HUMAN SERVICES
proposed information collection for the
Terry S. Clark, Solicitation of Nominations for
proper performance of the agency’s
functions, (2) the accuracy of the Asst. Information Collection Clearance Membership on the National Vaccine
Officer. Advisory Committee
estimated burden, (3) ways to enhance
[FR Doc. 2016–10199 Filed 4–29–16; 8:45 am]
the quality, utility, and clarity of the AGENCY: National Vaccine Program
information to be collected, and (4) the BILLING CODE 4150–28–P
Office, Office of the Assistant Secretary
use of automated collection techniques
srobinson on DSK5SPTVN1PROD with NOTICES
for Health, Office of the Secretary,
or other forms of information Department of Health and Human
Services.
ACTION: Notice.
AUTHORITY: 42 U.S.C. 300aa–5, Section
2105 of the Public Health Service (PHS)
Act, as amended. The National Vaccine
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Document Created: 2016-04-30 13:35:30
Document Modified: 2016-04-30 13:35:30
| 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 the ICR must be received on or before July 1, 2016. | |
| Contact | Information Collection Clearance staff, [email protected] or (202) 690-6162. | |
| FR Citation | 81 FR 26237 |
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