83 FR 49936 - Agency Information Collection Request. 60-Day Public Comment Request
DEPARTMENT OF HEALTH AND HUMAN SERVICES Federal Register Volume 83, Issue 192 (October 3, 2018)
Federal Register Volume 83, Issue 192 (October 3, 2018)
| Page Range | 49936-49937 | |
| FR Document | 2018-21520 |
[Federal Register Volume 83, Number 192 (Wednesday, October 3, 2018)] [Notices] [Pages 49936-49937] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-21520] ----------------------------------------------------------------------- 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 3, 2018. ADDRESSES: Submit your comments to [email protected] 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 [email protected], or call 202- 795-7714, 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: Fertility Knowledge Survey. Type of Collection: OMB No. 0990-NEW--Office of the Assistant Secretary for Health (OASH). Abstract: The Office of the Assistant Secretary for Health/Office of Population Affairs (OPA) is seeking an approval by the Office of Management and Budget on a new information collection. We seek to collect information to increase understanding of (1) adolescent and young adult knowledge of human (female and male) fertility and (2) how this knowledge is related to behaviors and intentions involving childbearing. We propose to collect this information through a 20- minute web survey (Fertility Knowledge Survey) of 2,100 females and 1,900 males, aged 15 to 29 years, using an online panel that is based on a probability-based sample of the U.S. population. The survey will produce evidence and findings that are expected to be generalizable to the population of English-speaking females and males aged 15 to 29 years in the United States. Possessing accurate knowledge about human fertility is important information that enables reproductive-aged women and men to make informed decisions and plans about reproduction and empowers them to seek appropriate and timely health services (e.g., family planning, related preventive healthcare, or infertility assessment) to achieve those plans. OPA requires high-quality information on the fertility knowledge and related behaviors of U.S. adolescents and young adults to inform Title X policies and strategies that aim to close knowledge gaps, enhance reproductive life planning, and increase access to appropriate and evidence-informed care. The Fertility Knowledge Survey will be administered once to each respondent. Respondents will include English-speaking females and males, aged 15 to 29 years, who are able to get pregnant or father a child, respectively. This study will rely on a web survey to [[Page 49937]] be self-administered at home on personal computers, tablets, or phones. A web survey has numerous methodological advantages, including increased accuracy in measurement of key variables of interest, and reduced burden on study participants. Respondents in this study will be members of the general public. This collection will not involve small business or small entities. The estimated annualized hour burden of responding to this information collection is 1,333 hours, or a weighted average of 20 minutes (.33 hours) per respondent. The hour-burden estimate includes the time spent by a respondent to read the email invitation, review the online consent or assent (minor), and complete the survey. Participation is voluntary and there are no costs to respondents other than their time. OMB approval is requested for three years. Annualized Burden Hour Table ---------------------------------------------------------------------------------------------------------------- Number of Forms (if necessary) Respondents (if Number of responses per Average burden Total burden necessary) respondents respondents per response hours ---------------------------------------------------------------------------------------------------------------- Fertility Knowledge Survey.... General Public, 4,000 1 20/60 1,333 aged 15 to 29 years. rrrrrrrrrrrrrrrrrrrrrrrrrrrrrrr Total..................... ................ .............. 4,000 .............. 1,333 ---------------------------------------------------------------------------------------------------------------- Dated: September 27, 2018. Terry Clark, Paperwork Reduction Act Reports Clearance Officer, Office of the Secretary. [FR Doc. 2018-21520 Filed 10-2-18; 8:45 am] BILLING CODE 4150-34-P
![49936 Federal Register / Vol. 83, No. 192 / Wednesday, October 3, 2018 / Notices
Service Act (42 U.S.C. 262(k), referred to the Paperwork Reduction Act of 1995 SUPPLEMENTARY INFORMATION: Interested
in this document as a 351(k) (PRA) (44 U.S.C. 3501–3520). The persons are invited to send comments
application). collections of information in 21 CFR regarding this burden estimate or any
This draft guidance describes how the 10.20, 10.30, and 10.35 have been other aspect of this collection of
Agency determines if: (1) The approved under OMB control number information, including any of the
provisions of section 505(q) of the FD&C 0910–0191; the collections of following subjects: (1) The necessity and
Act addressing the treatment of citizen information in § 10.31 have been utility of the proposed information
petitions and petitions for stay of approved under OMB control number collection for the proper performance of
Agency action (collectively, petitions) 0910–0679; and the collections of the agency’s functions; (2) the accuracy
apply to a particular petition and (2) a information in 21 CFR 314.54, 314.94, of the estimated burden; (3) ways to
petition would delay approval of a and 314.102 have been approved under enhance the quality, utility, and clarity
pending ANDA, 505(b)(2) application, OMB control number 0910–0001. The of the information to be collected; and
or 351(k) application. This draft certification and verification statements (4) the use of automated collection
guidance also describes how FDA required under § 10.31(c) and (d) are techniques or other forms of information
implements the provisions of section ‘‘public disclosure[s] of information technology to minimize the information
505(q) requiring that: (1) A petition originally supplied by the Federal collection burden.
include a certification and (2) government to the recipient for the Title of the Collection: Fertility
supplemental information or comments purpose of disclosure to the public Knowledge Survey.
to a petition include a verification. It . . .’’ (5 CFR 1320.3(c)(2)) and therefore Type of Collection: OMB No. 0990–
also addresses the relationship between not subject to OMB review under the NEW—Office of the Assistant Secretary
the review of petitions and pending PRA. for Health (OASH).
ANDAs, 505(b)(2) applications, and Abstract: The Office of the Assistant
351(k) applications for which the III. Electronic Access Secretary for Health/Office of
Agency has not yet made a decision on Persons with access to the internet Population Affairs (OPA) is seeking an
approvability. may obtain the draft guidance at either approval by the Office of Management
This draft guidance revises the http://www.fda.gov/Drugs/Guidance and Budget on a new information
guidance for industry entitled ‘‘Citizen ComplianceRegulatoryInformation/ collection. We seek to collect
Petitions and Petitions for Stay of Guidances/default.htm or https:// information to increase understanding
Action Subject to Section 505(q) of the www.regulations.gov. of (1) adolescent and young adult
Federal Food, Drug, and Cosmetic Act’’ knowledge of human (female and male)
issued in November 2014. This draft Dated: September 28, 2018. fertility and (2) how this knowledge is
guidance updates the November 2014 Leslie Kux, related to behaviors and intentions
guidance to account for recent Associate Commissioner for Policy. involving childbearing. We propose to
regulatory changes to add § 10.31 (21 [FR Doc. 2018–21532 Filed 10–2–18; 8:45 am] collect this information through a 20-
CFR 10.31) to FDA’s regulations and BILLING CODE 4164–01–P minute web survey (Fertility Knowledge
modify 21 CFR 10.30 and 10.35. The Survey) of 2,100 females and 1,900
revision also describes a change in males, aged 15 to 29 years, using an
FDA’s current thinking on what DEPARTMENT OF HEALTH AND online panel that is based on a
constitutes a 505(q) petition. In HUMAN SERVICES probability-based sample of the U.S.
addition, FDA is revising this guidance population. The survey will produce
to describe some of the considerations [Document Identifier OS–0990–New] evidence and findings that are expected
FDA will take into account in to be generalizable to the population of
determining whether a petition is Agency Information Collection English-speaking females and males
submitted with the primary purpose of Request. 60-Day Public Comment aged 15 to 29 years in the United States.
delaying the approval of an application Request Possessing accurate knowledge about
under section 505(q)(1)(E) of the FD&C AGENCY: Office of the Secretary, HHS. human fertility is important information
Act. that enables reproductive-aged women
ACTION: Notice. and men to make informed decisions
This draft guidance is being issued
consistent with FDA’s good guidance SUMMARY: In compliance with the and plans about reproduction and
practices regulation (21 CFR 10.115). requirement of the Paperwork empowers them to seek appropriate and
The draft guidance, when finalized, will Reduction Act of 1995, the Office of the timely health services (e.g., family
represent the current thinking of FDA Secretary (OS), Department of Health planning, related preventive healthcare,
on citizen petitions and petitions for and Human Services, is publishing the or infertility assessment) to achieve
stay of action subject to section 505(q) following summary of a proposed those plans. OPA requires high-quality
of the FD&C Act. It does not establish collection for public comment. information on the fertility knowledge
any rights for any person and is not and related behaviors of U.S.
DATES: Comments on the ICR must be
binding on FDA or the public. You can adolescents and young adults to inform
received on or before December 3, 2018.
use an alternative approach if it satisfies Title X policies and strategies that aim
ADDRESSES: Submit your comments to to close knowledge gaps, enhance
the requirements of the applicable
statutes and regulations. This guidance Sherrette.Funn@hhs.gov or by calling reproductive life planning, and increase
is not subject to Executive Order 12866. (202) 795–7714. access to appropriate and evidence-
FOR FURTHER INFORMATION CONTACT: informed care.
daltland on DSKBBV9HB2PROD with NOTICES
II. Paperwork Reduction Act of 1995 When submitting comments or The Fertility Knowledge Survey will
This draft guidance refers to requesting information, please include be administered once to each
previously approved collections of the document identifier 0990–New–60D respondent. Respondents will include
information found in FDA regulations. and project title for reference, to English-speaking females and males,
These collections of information are Sherrette.funn@hhs.gov, or call 202– aged 15 to 29 years, who are able to get
subject to review by the Office of 795–7714, the Reports Clearance pregnant or father a child, respectively.
Management and Budget (OMB) under Officer. This study will rely on a web survey to
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![Federal Register / Vol. 83, No. 192 / Wednesday, October 3, 2018 / Notices 49937
be self-administered at home on members of the general public. This estimate includes the time spent by a
personal computers, tablets, or phones. collection will not involve small respondent to read the email invitation,
A web survey has numerous business or small entities. review the online consent or assent
methodological advantages, including The estimated annualized hour (minor), and complete the survey.
increased accuracy in measurement of burden of responding to this Participation is voluntary and there are
key variables of interest, and reduced information collection is 1,333 hours, or no costs to respondents other than their
burden on study participants. a weighted average of 20 minutes (.33 time. OMB approval is requested for
Respondents in this study will be hours) per respondent. The hour-burden three years.
ANNUALIZED BURDEN HOUR TABLE
Number of Average
Forms Respondents Number of responses Total burden
burden per
(if necessary) (if necessary) respondents per hours
response
respondents
Fertility Knowledge Survey ............... General Public, aged 15 to 29 years 4,000 1 20/60 1,333
Total ........................................... ........................................................... ........................ 4,000 ........................ 1,333
Dated: September 27, 2018. Vascular Diseases Research; 93.838, Lung Mental Health, National Institutes of Health,
Terry Clark, Diseases Research; 93.839, Blood Diseases 6001 Executive Boulevard, NSC 6152B,
Paperwork Reduction Act Reports Clearance and Resources Research, National Institutes Bethesda, MD 20892, 301–402–8152,
Officer, Office of the Secretary. of Health, HHS) erin.gray@nih.gov.
Dated: September 27, 2018. Name of Committee: National Institute of
[FR Doc. 2018–21520 Filed 10–2–18; 8:45 am]
Mental Health Special Emphasis Panel;
BILLING CODE 4150–34–P Ronald J. Livingston, Jr.,
NIMH Pathway to Independence Awards
Program Analyst, Office of Federal Advisory (K99/R00).
Committee Policy. Date: October 24, 2018.
DEPARTMENT OF HEALTH AND [FR Doc. 2018–21501 Filed 10–2–18; 8:45 am] Time: 12:00 p.m. to 5:00 p.m.
HUMAN SERVICES BILLING CODE 4140–01–P Agenda: To review and evaluate grant
applications.
National Institutes of Health Place: National Institutes of Health,
DEPARTMENT OF HEALTH AND Neuroscience Center, 6001 Executive
National Heart, Lung, and Blood Boulevard, Rockville, MD 20852 (Virtual
HUMAN SERVICES
Institute; Notice of Closed Meetings Meeting).
Contact Person: David W. Miller, Ph.D.,
Pursuant to section 10(d) of the National Institutes of Health Scientific Review Officer, Division of
Federal Advisory Committee Act, as Extramural Activities, National Institute of
amended (5 U.S.C. App.), notice is National Institute of Mental Health; Mental Health, NIH, Neuroscience Center,
hereby given of the following meeting. Notice of Closed Meetings 6001 Executive Blvd., Room 6140, MSC 9608,
The meeting will be closed to the Bethesda, MD 20892–9608, 301–443–9734,
Pursuant to section 10(d) of the millerda@mail.nih.gov.
public in accordance with the Federal Advisory Committee Act, as
provisions set forth in sections (Catalogue of Federal Domestic Assistance
amended, notice is hereby given of the Program No. 93.242, Mental Health Research
552b(c)(4) and 552b(c)(6), Title 5 U.S.C., following meetings.
as amended. The grant applications and Grants, National Institutes of Health, HHS)
The meetings will be closed to the
the discussions could disclose public in accordance with the Dated: September 27, 2018.
confidential trade secrets or commercial provisions set forth in sections Melanie J. Pantoja,
property such as patentable material, 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., Program Analyst, Office of Federal Advisory
and personal information concerning as amended. The grant applications and Committee Policy.
individuals associated with the grant the discussions could disclose [FR Doc. 2018–21504 Filed 10–2–18; 8:45 am]
applications, the disclosure of which confidential trade secrets or commercial BILLING CODE 4140–01–P
would constitute a clearly unwarranted property such as patentable material,
invasion of personal privacy. and personal information concerning
Name of Committee: Heart, Lung, and individuals associated with the grant DEPARTMENT OF HEALTH AND
Blood Initial Review Group; Clinical Trials applications, the disclosure of which HUMAN SERVICES
Review Committee. would constitute a clearly unwarranted
Date: October 25–26, 2018. National Institutes of Health
invasion of personal privacy.
Time: 8:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant Name of Committee: National Institute of National Heart, Lung, and Blood
applications. Mental Health Special Emphasis Panel;
Place: Residence Inn Bethesda, 7335 Jointly Sponsored Predoctoral Training
Institute; Notice of Closed Meetings
Wisconsin Avenue, Bethesda, MD 20814. Program in the Neurosciences (T32). Pursuant to section 10(d) of the
Contact Person: Keary A. Cope, Ph.D., Date: October 23, 2018. Federal Advisory Committee Act, as
daltland on DSKBBV9HB2PROD with NOTICES
Scientific Review Officer, Office of Scientific Time: 8:00 a.m. to 5:00 p.m.
Review/DERA, National Heart, Lung, and
amended (5 U.S.C. App.), notice is
Agenda: To review and evaluate grant
Blood Institute, 6701 Rockledge Drive, Room applications.
hereby given of the following meetings.
7190, Bethesda, MD 20892–7924, 301–827– Place: The Westin Georgetown, 2350 M
The meetings will be closed to the
7912, copeka@mail.nih.gov. Street NW, Washington, DC 20037. public in accordance with the
(Catalogue of Federal Domestic Assistance Contact Person: Erin E. Gray, Ph.D., provisions set forth in sections
Program Nos. 93.233, National Center for Scientific Review Officer, Division of 552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
Sleep Disorders Research; 93.837, Heart and Extramural Activities, National Institute of as amended. The grant applications and
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Document Created: 2018-10-03 02:29:39
Document Modified: 2018-10-03 02:29:39
| 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 3, 2018. | |
| 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 202- 795-7714, the Reports Clearance Officer. | |
| FR Citation | 83 FR 49936 |
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