82 FR 47536 - Agency Information Collection Request; 60-Day Public Comment Request
DEPARTMENT OF HEALTH AND HUMAN SERVICES Federal Register Volume 82, Issue 196 (October 12, 2017)
Federal Register Volume 82, Issue 196 (October 12, 2017)
| Page Range | 47536-47537 | |
| FR Document | 2017-21983 |
[Federal Register Volume 82, Number 196 (Thursday, October 12, 2017)] [Notices] [Pages 47536-47537] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-21983] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES [Document Identifier OS-0990-new] Agency Information Collection Request; 60-Day Public Comment Request AGENCY: Office of the Secretary, HHS ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: In compliance with the requirement of the Paperwork Reduction Act of 1995, the Office of the Secretary (OS), Department of Health and Human Services, is publishing the following summary of a proposed collection for public comment. DATES: Comments on the ICR must be received on or before December 11, 2017. ADDRESSES: Submit your comments to Sherrette.Funn@hhs.gov or by calling (202) 795-7714. FOR FURTHER INFORMATION CONTACT: When submitting comments or requesting information, please include the document identifier 0990-New-60D and project title for reference, to Sherrette.funn@hhs.gov, or call the Reports Clearance Officer. SUPPLEMENTARY INFORMATION: Interested persons are invited to send comments regarding this burden estimate or any other aspect of this collection of information, including any of the following subjects: (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. Title of the Collection: I Can Do It, You Can Do It! Program Evaluation. Type of Collection: New. OMB No. 0990-NEW-Office within OS--Office of the President's Council on Fitness, Sports & Nutrition (OPCFSN), Office of the Assistant Secretary for Health. Abstract: Initiated by the former HHS Office on Disability, supported by the Eunice Kennedy Shriver National Institute of Child Health and Human Development and the former Division of Nutrition Research Coordination at the National Institutes of Health, and adopted by OPCFSN in 2011, the I Can Do It, You Can Do It! health promotion program is designed to provide access and opportunities for children and adults with a wide range of physical and cognitive disabilities to lead healthy, active lives. Approximately 56 million children and adults living in the United States have some level of disability. Despite physical activity and good nutrition being the cornerstones of evidence-based health promotion interventions for reducing the risk of comorbidities (e.g., diabetes, heart disease, stroke), many people with a disability or caregivers who have a child with a disability experience substantial difficulty accessing these programs. The program partners with K-12 schools and school districts, colleges and universities, and other community-based entities that implement the program using a mentoring approach that has been well-documented in the research literature as efficacious in changing the attitudes, knowledge, and health behaviors of individuals with and without a disability. The information collected for the I Can Do It, You Can Do It! Program Evaluation will allow the OPCFSN and partners to assess the impact of the program and gather critical information for improvement. [[Page 47537]] Annualized Burden Hour Table ---------------------------------------------------------------------------------------------------------------- Number of Average Forms Respondents Number of responses per burden per Total burden respondents respondents response hours ---------------------------------------------------------------------------------------------------------------- Advocate Form................ Site Coordinator 10 1 20/60 3 Advocate Annual Follow-Up Site Coordinator 10 1 20/60 3 Survey. End of Wave 1 Interview Site Coordinator 10 1 1 10 Script. End of Wave 1 Feedback Survey Site Coordinator 10 1 45/60 8 End of Wave 2 Interview...... Site Coordinator 10 1 1 10 End of Wave 2 Feedback Survey Site Coordinator 10 1 20/60 3 Technical Assistance Site Coordinator 10 1 25/60 4 Assessment. Mentee Pre-Assessment........ Mentee/Program 700 1 20/60 233 Participant. Mentee Post-Assessment....... Mentee/Program 700 1 20/60 233 Participant. Mentor Feedback Survey....... Mentor.......... 700 1 15/60 175 Weekly Goal-Setting Guide.... Mentor.......... 700 10 10/60 1166 Mentee Focus Group Script.... Mentee/Program 60 1 1 60 Participant. Parent/Guardian Focus Group Mentee's Parent/ 60 1 1 60 Script. Guardian. ---------------------------------------------------------------- Total.................... ................ .............. 22 .............. 1968 ---------------------------------------------------------------------------------------------------------------- Terry S. Clark, Office of the Secretary, Asst Paperwork Reduction Act Reports Clearance Officer. [FR Doc. 2017-21983 Filed 10-11-17; 8:45 am] BILLING CODE 4150-35-P
![47536 Federal Register / Vol. 82, No. 196 / Thursday, October 12, 2017 / Notices
received, go to https:// guidance is not subject to Executive regarding this burden estimate or any
www.regulations.gov and insert the Order 12866. other aspect of this collection of
docket number, found in brackets in the information, including any of the
II. The Paperwork Reduction Act of
heading of this document, into the following subjects: (1) The necessity and
1995
‘‘Search’’ box and follow the prompts utility of the proposed information
and/or go to the Dockets Management This draft guidance refers to collection for the proper performance of
Staff, 5630 Fishers Lane, Rm. 1061, previously approved collections of the agency’s functions; (2) the accuracy
Rockville, MD 20852. information that are subject to review by of the estimated burden; (3) ways to
You may submit comments on any the Office of Management and Budget enhance the quality, utility, and clarity
guidance at any time (see 21 CFR (OMB) under the Paperwork Reduction of the information to be collected; and
10.115(g)(5)). Act of 1995 (44 U.S.C. 3501–3520). The (4) the use of automated collection
Submit written requests for single collections of information in 21 CFR techniques or other forms of information
parts 312 and 314 have been approved technology to minimize the information
copies of the draft guidance to the
under OMB control numbers 0910–0014 collection burden.
Division of Drug Information, Center for
and 0910–0001, respectively.
Drug Evaluation and Research, Food Title of the Collection: I Can Do It,
and Drug Administration, 10001 New III. Electronic Access You Can Do It! Program Evaluation.
Hampshire Ave., Hillandale Building, Persons with access to the internet Type of Collection: New.
4th Floor, Silver Spring, MD 20993– may obtain the draft guidance at either OMB No. 0990–NEW–Office within
0002. Send one self-addressed adhesive https://www.fda.gov/Drugs/Guidance OS—Office of the President’s Council
label to assist that office in processing ComplianceRegulatoryInformation/ on Fitness, Sports & Nutrition
your requests. See the SUPPLEMENTARY Guidances/default.htm or https:// (OPCFSN), Office of the Assistant
INFORMATION section for electronic www.regulations.gov. Secretary for Health.
access to the draft guidance document. Abstract: Initiated by the former HHS
Dated: October 5, 2017.
FOR FURTHER INFORMATION CONTACT: Anna K. Abram, Office on Disability, supported by the
Jeffrey Murray, Center for Drug Deputy Commissioner for Policy, Planning, Eunice Kennedy Shriver National
Evaluation and Research, Food and Legislation, and Analysis. Institute of Child Health and Human
Drug Administration, 10903 New [FR Doc. 2017–22051 Filed 10–11–17; 8:45 am] Development and the former Division of
Hampshire Ave., Bldg. 22, Rm. 6360, Nutrition Research Coordination at the
BILLING CODE 4164–01–P
Silver Spring, MD 20993–0002, 301– National Institutes of Health, and
796–1500. adopted by OPCFSN in 2011, the I Can
SUPPLEMENTARY INFORMATION: DEPARTMENT OF HEALTH AND Do It, You Can Do It! health promotion
HUMAN SERVICES program is designed to provide access
I. Background and opportunities for children and
[Document Identifier OS–0990–new]
FDA is announcing the availability of adults with a wide range of physical and
a draft guidance for industry entitled Agency Information Collection cognitive disabilities to lead healthy,
‘‘Respiratory Syncytial Virus Infection: Request; 60-Day Public Comment active lives. Approximately 56 million
Developing Antiviral Drugs for Request children and adults living in the United
Prophylaxis and Treatment.’’ This draft States have some level of disability.
guidance addresses FDA’s current AGENCY: Office of the Secretary, HHS Despite physical activity and good
thinking regarding the overall drug ACTION: Notice. nutrition being the cornerstones of
development program for an indication evidence-based health promotion
SUMMARY: In compliance with the interventions for reducing the risk of
for treatment and prevention of disease
requirement of the Paperwork comorbidities (e.g., diabetes, heart
caused by RSV infection including
Reduction Act of 1995, the Office of the disease, stroke), many people with a
nonclinical development, early phases
Secretary (OS), Department of Health disability or caregivers who have a child
of clinical development, and phase 3
and Human Services, is publishing the with a disability experience substantial
trial designs. This draft guidance
following summary of a proposed difficulty accessing these programs. The
focuses primarily on pediatric antiviral
collection for public comment. program partners with K–12 schools and
drug development for RSV but also
DATES: Comments on the ICR must be school districts, colleges and
discusses drug development for other
populations. received on or before December 11, universities, and other community-
2017. based entities that implement the
This draft guidance is being issued
consistent with FDA’s good guidance ADDRESSES: Submit your comments to program using a mentoring approach
practices regulation (21 CFR 10.115). Sherrette.Funn@hhs.gov or by calling that has been well-documented in the
The draft guidance, when finalized, will (202) 795–7714. research literature as efficacious in
represent the current thinking of FDA FOR FURTHER INFORMATION CONTACT: changing the attitudes, knowledge, and
on ‘‘Respiratory Syncytial Virus When submitting comments or health behaviors of individuals with
Infection: Developing Antiviral Drugs requesting information, please include and without a disability.
for Prophylaxis and Treatment.’’ It does the document identifier 0990-New-60D The information collected for the I
not establish any rights for any person and project title for reference, to Can Do It, You Can Do It! Program
asabaliauskas on DSKBBXCHB2PROD with NOTICES
and is not binding on FDA or the public. Sherrette.funn@hhs.gov, or call the Evaluation will allow the OPCFSN and
You can use an alternative approach if Reports Clearance Officer. partners to assess the impact of the
it satisfies the requirements of the SUPPLEMENTARY INFORMATION: Interested program and gather critical information
applicable statutes and regulations. This persons are invited to send comments for improvement.
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![Federal Register / Vol. 82, No. 196 / Thursday, October 12, 2017 / Notices 47537
ANNUALIZED BURDEN HOUR TABLE
Number of Average Total
Number of
Forms Respondents responses per burden per burden
respondents respondents response hours
Advocate Form ................................. Site Coordinator .............................. 10 1 20/60 3
Advocate Annual Follow-Up Survey Site Coordinator .............................. 10 1 20/60 3
End of Wave 1 Interview Script ....... Site Coordinator .............................. 10 1 1 10
End of Wave 1 Feedback Survey .... Site Coordinator .............................. 10 1 45/60 8
End of Wave 2 Interview ................. Site Coordinator .............................. 10 1 1 10
End of Wave 2 Feedback Survey .... Site Coordinator .............................. 10 1 20/60 3
Technical Assistance Assessment .. Site Coordinator .............................. 10 1 25/60 4
Mentee Pre-Assessment .................. Mentee/Program Participant ............ 700 1 20/60 233
Mentee Post-Assessment ................ Mentee/Program Participant ............ 700 1 20/60 233
Mentor Feedback Survey ................. Mentor ............................................. 700 1 15/60 175
Weekly Goal-Setting Guide ............. Mentor ............................................. 700 10 10/60 1166
Mentee Focus Group Script ............. Mentee/Program Participant ............ 60 1 1 60
Parent/Guardian Focus Group Mentee’s Parent/Guardian .............. 60 1 1 60
Script.
Total .......................................... .......................................................... ........................ 22 ........................ 1968
Terry S. Clark, Abuse and Alcoholism, National Institutes of DEPARTMENT OF HEALTH AND
Office of the Secretary, Asst Paperwork Health, 5635 Fishers Lane, Room 2109, HUMAN SERVICES
Reduction Act Reports Clearance Officer. Rockville, MD 20852 301–443–8599,
[FR Doc. 2017–21983 Filed 10–11–17; 8:45 am] rippera@mail.nih.gov. National Institutes of Health
BILLING CODE 4150–35–P This notice is being published less than 15
days prior to the meeting due to the timing Prospective Grant of Exclusive Patent
limitations imposed by the review and License: DNA-Based Vaccine for
DEPARTMENT OF HEALTH AND funding cycle. Prevention of Zika Virus Infection
HUMAN SERVICES Name of Committee: National Institute on
AGENCY: National Institutes of Health,
Alcohol Abuse and Alcoholism Special
National Institutes of Health Department of Health and Human
Emphasis Panel, SEP Review Member
Services.
Conflict Applications.
National Institute on Alcohol Abuse Date: November 14, 2017. ACTION: Notice.
and Alcoholism; Notice of Closed Time: 2:00 p.m. to 4:00 p.m.
Meetings Agenda: To review and evaluate grant SUMMARY: The National Institute of
applications. Allergy and Infectious Diseases (NIAID),
Pursuant to section 10(d) of the an institute of the National Institutes of
Place: National Institutes of Health,
Federal Advisory Committee Act, as Health, Department of Health and
National Institute on Alcohol Abuse and
amended, notice is hereby given of the Human Services, is contemplating the
Alcoholism, 5635 Fishers Lane, Rockville,
following meetings. grant of an Exclusive Commercialization
MD 20892 (Telephone Conference Call).
The meetings will be closed to the Patent License to PaxVax, Inc., located
Contact Person: Anna Ghambaryan, M.D.,
public in accordance with the Scientific Review Officer, Office of in Redwood City, California, to practice
provisions set forth in sections Extramural Activities, National Institute on the inventions embodied in the patent
552b(c)(4) and 552b(c)(6), Title 5 U.S.C., Alcohol Abuse and Alcoholism, National applications listed in the
as amended. The grant applications and Institutes of Health, 5635 Fishers Lane, SUPPLEMENTARY INFORMATION section of
the discussions could disclose Rockville, MD 20852, 301–443–4032, this notice.
confidential trade secrets or commercial anna.ghambaryan@nih.gov. DATES: Only written comments and/or
property such as patentable material,
(Catalogue of Federal Domestic Assistance applications for a license which are
and personal information concerning
Program Nos. 93.271, Alcohol Research received by the National Institute of
individuals associated with the grant
Career Development Awards for Scientists Allergy and Infectious Diseases’
applications, the disclosure of which
and Clinicians; 93.272, Alcohol National Technology Transfer and Intellectual
would constitute a clearly unwarranted Research Service Awards for Research
invasion of personal privacy. Property Office on or before November
Training; 93.273, Alcohol Research Programs; 13, 2017 will be considered.
Name of Committee: National Institute on 93.891, Alcohol Research Center Grants;
Alcohol Abuse and Alcoholism, Special ADDRESSES: Requests for copies of the
93.701, ARRA Related Biomedical Research
Emphasis Panel; NIAAA Fellowship Review. patent applications, inquiries, and
and Research Support Awards., National
Date: November 2, 2017. Institutes of Health, HHS).
comments relating to the contemplated
Time: 8:30 a.m. to 6:00 p.m. Exclusive Commercialization Patent
Dated: October 5, 2017.
asabaliauskas on DSKBBXCHB2PROD with NOTICES
Agenda: To review and evaluate grant License should be directed to: Dr. Amy
applications. Melanie J. Pantoja, Petrik, Technology Transfer and Patent
Place: National Institutes of Health, Specialist, Technology Transfer and
Program Analyst, Office of Federal Advisory
National Institute on Alcohol Abuse and Intellectual Property Office, National
Alcoholism, Terrace Conference Room, 5635 Committee Policy.
Fishers Lane, Bethesda, MD 20892. [FR Doc. 2017–21989 Filed 10–11–17; 8:45 am] Institute of Allergy and Infectious
Contact Person: Richard A. Rippe, Ph.D., BILLING CODE 4140–01–P
Diseases, 5601 Fishers Lane, Suite 2G,
Scientific Review Officer, Extramural Project MSC9804, Rockville, MD 20852–9804,
Review Branch, Office of Extramural phone number 301–496–2644, or
Activities, National Institute on Alcohol petrika@mail.nih.gov.
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Document Created: 2018-10-25 10:05:30
Document Modified: 2018-10-25 10:05:30
| 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 December 11, 2017. | |
| Contact | When submitting comments or requesting information, please include the document identifier 0990-New-60D and project title for reference, to [email protected], or call the Reports Clearance Officer. | |
| FR Citation | 82 FR 47536 |
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