80 FR 21744 - Agency Information Collection Activities; Submission to OMB for Review and Approval; Public Comment Request
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Office of the Secretary Federal Register Volume 80, Issue 75 (April 20, 2015)
Office of the Secretary
Federal Register Volume 80, Issue 75 (April 20, 2015)
| Page Range | 21744-21745 | |
| FR Document | 2015-08960 |
[Federal Register Volume 80, Number 75 (Monday, April 20, 2015)] [Notices] [Pages 21744-21745] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-08960] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Office of the Secretary [Document Identifier: HHS-OS-0990-0392-30-D] Agency Information Collection Activities; Submission to OMB for Review and Approval; Public Comment Request AGENCY: Office of the Secretary, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: In compliance with section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the Office of the Secretary (OS), Department of Health and Human Services, has submitted an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB) for review and approval. The ICR is for renewal of the approved information collection assigned OMB control number 0990-0392, scheduled to expire on May 31, 2015. Comments submitted during the first public review of this ICR will be provided to OMB. OMB will accept further comments from the public on this ICR during the review and approval period. DATES: Comments on the ICR must be received on or before May 20, 2015. ADDRESSES: Submit your comments to OIRA_submission@omb.eop.gov or via facsimile to (202) 395-5806. 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 OMB control number 0990-0392 and document identifier HHS-OS0990-0392-30D for reference. Information Collection Request Title: Office of Adolescent Health and Administration for Children, Youth and Families Teen Pregnancy Prevention Performance Measure Collection. Abstract: The Office of Adolescent Health (OAH), U.S. Department of Health and Human Services (HHS) is requesting an extension without change of a currently approved information collection request by OMB. The purpose of the extension is to complete the ongoing data collection for the Office of Adolescent Health and Administration for Children, Youth and Families Teen Pregnancy Prevention Performance Measures. Need and Proposed Use of the Information: To collect performance measure data on the OAH Teen [[Page 21745]] Pregnancy Prevention (TPP) Program and the ACF/FYSB Personal Responsibility Education Program Innovative Strategies (PREIS). These data will allow OAH and FYSB to monitor the progress of program grantees, and to report to Congress on the performance of the programs. Likely Respondents: The 106 TPP and PREIS grantees and approximately 2000 PREIS youth participants. 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 Forms (if necessary) Type of Number of responses per burden hours Total burden respondent respondents respondent per response hours ---------------------------------------------------------------------------------------------------------------- Measures for all grantees..... Grantee program 106 1 7 742 staff--all. Participant-level measures.... Grantee program 45 1 1 45 staff--Tier 1 C/ D, Tier 2, and PREIS. Perceived impact questions.... Youth 2,000 1 5/60 167 participants--P REIS. Perceived impact measures..... Grantee program 11 1 3 33 staff--PREIS. --------------- Total..................... ................ .............. .............. .............. 987 ---------------------------------------------------------------------------------------------------------------- Terry S. Clark, Asst Information Collection Clearance Officer. [FR Doc. 2015-08960 Filed 4-17-15; 8:45 am] BILLING CODE 4168-11-P
![21744 Federal Register / Vol. 80, No. 75 / Monday, April 20, 2015 / Notices
Web sites provide some labeling, FDA project. During the pilot, CDRH staff DEPARTMENT OF HEALTH AND
believes that most do not provide the will be available to answer any HUMAN SERVICES
label and package insert for all of their questions or concerns that may arise.
home-use devices listed with FDA. Pilot project participants will be asked Office of the Secretary
II. CDRH Home Use Device Labeling to comment on and discuss their [Document Identifier: HHS–OS–0990–0392–
Pilot experiences with the pilot submissions 30–D]
process. Their comments and
CDRH is developing an electronic Agency Information Collection
discussions will assist CDRH in its
submissions database, accessible to the Activities; Submission to OMB for
public through FDA’s Web site, of labels development of this electronic
submissions database. Review and Approval; Public Comment
and package inserts for listed home-use Request
devices. This database would fill an III. Duration of the Home Use Device
important gap in the information Labeling Pilot AGENCY: Office of the Secretary, HHS.
available to patients, caregivers, and the ACTION: Notice.
healthcare community concerning FDA intends to accept requests for
home-use devices. The database would participation in the Home Use Device SUMMARY: In compliance with section
allow both broad searches to identify Labeling Pilot from May 1, 2015, 3507(a)(1)(D) of the Paperwork
legally marketed home-use devices that through May 31, 2015. The pilot will Reduction Act of 1995, the Office of the
may fill a particular need and focused proceed for 6 months, from July 1, 2015, Secretary (OS), Department of Health
searches to obtain information through December 31, 2015. This pilot and Human Services, has submitted an
concerning the use of a specific home- program may be extended as resources Information Collection Request (ICR),
use device. described below, to the Office of
and needs allow.
This electronic submissions database Management and Budget (OMB) for
will be evaluated for usability through IV. Paperwork Reduction Act of 1995 review and approval. The ICR is for
the CDRH Home Use Device Labeling renewal of the approved information
Pilot Project. This pilot project will This notice refers to previously collection assigned OMB control
proceed for 6 months. Participation in approved collections of information number 0990–0392, scheduled to expire
the pilot is open to applicants who label found in FDA regulations. These on May 31, 2015. Comments submitted
their device(s) for home use. collections of information are subject to during the first public review of this ICR
Participants will be asked to navigate review by the Office of Management and will be provided to OMB. OMB will
through the electronic submissions Budget (OMB) under the Paperwork accept further comments from the
system and practice submitting labels Reduction Act of 1995 (44 U.S.C. 3501– public on this ICR during the review
and package inserts. The pilot project is 3520). The collections of information in and approval period.
intended to provide industry and CDRH 21 CFR parts 801 and 809 have been DATES: Comments on the ICR must be
staff the opportunity to evaluate the approved under OMB control number received on or before May 20, 2015.
submissions process and system and to 0910–0485. ADDRESSES: Submit your comments to
receive comments from industry OIRA_submission@omb.eop.gov or via
participants. Comments received during V. Comments
facsimile to (202) 395–5806.
the pilot project will be used to evaluate Interested persons may submit FOR FURTHER INFORMATION CONTACT:
the usability of the database. FDA will electronic comments regarding the Information Collection Clearance staff,
not review the content of any labeling
Home Use Device Labeling Pilot to Information.CollectionClearance@
submitted to the pilot database for a
http://www.regulations.gov or written hhs.gov or (202) 690–6162.
regulatory purpose. The submitted
labeling and the database will only be comments to the Division of Dockets SUPPLEMENTARY INFORMATION: When
available to pilot participants. Management (HFA–305), Food and Drug submitting comments or requesting
Administration, 5630 Fishers Lane, Rm. information, please include the OMB
A. Participation 1061, Rockville, MD 20852. It is only control number 0990–0392 and
Volunteers interested in participating necessary to send one set of comments. document identifier HHS–OS0990–
in the pilot project should contact pilot Identify comments with the docket 0392–30D for reference.
staff by email at Mary.Brady@ number found in brackets in the Information Collection Request Title:
fda.hhs.gov. The following information heading of this document. Received Office of Adolescent Health and
should be included in the request: comments may be seen in the Division Administration for Children, Youth and
Contact name, contact phone number, of Dockets Management between 9 a.m. Families Teen Pregnancy Prevention
and contact email address. FDA will and 4 p.m., Monday through Friday and Performance Measure Collection.
contact interested applicants to discuss will be posted to the docket at http:// Abstract: The Office of Adolescent
the pilot project. FDA is seeking a www.regulations.gov. Health (OAH), U.S. Department of
limited number of participants (no more Health and Human Services (HHS) is
than nine) to participate in this pilot Dated: April 14, 2015. requesting an extension without change
project. Leslie Kux, of a currently approved information
Associate Commissioner for Policy. collection request by OMB. The purpose
B. Procedures of the extension is to complete the
[FR Doc. 2015–08957 Filed 4–17–15; 8:45 am]
mstockstill on DSK4VPTVN1PROD with NOTICES
By following a series of prompts and BILLING CODE 4164–01–P
ongoing data collection for the Office of
instructions, pilot participants will Adolescent Health and Administration
submit a PDF version of their device for Children, Youth and Families Teen
labeling to the pilot database. The Pregnancy Prevention Performance
content of the submissions will not be Measures.
reviewed by FDA for any regulatory Need and Proposed Use of the
purpose, nor will the pilot database be Information: To collect performance
available to the public during this pilot measure data on the OAH Teen
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![Federal Register / Vol. 80, No. 75 / Monday, April 20, 2015 / Notices 21745
Pregnancy Prevention (TPP) Program Burden Statement: Burden in this and providing information, to train
and the ACF/FYSB Personal context means the time expended by personnel and to be able to respond to
Responsibility Education Program persons to generate, maintain, retain, a collection of information, to search
Innovative Strategies (PREIS). These disclose or provide the information data sources, to complete and review
data will allow OAH and FYSB to requested. This includes the time the collection of information, and to
monitor the progress of program needed to review instructions, to transmit or otherwise disclose the
grantees, and to report to Congress on develop, acquire, install and utilize information.
the performance of the programs. technology and systems for the purpose
Likely Respondents: The 106 TPP and of collecting, validating and verifying The total annual burden hours
PREIS grantees and approximately 2000 information, processing and estimated for this ICR are summarized
PREIS youth participants. maintaining information, and disclosing in the table below.
TOTAL ESTIMATED ANNUALIZED BURDEN—HOURS
Number of Average
Forms Type of Number of Total burden
responses per burden hours
(if necessary) respondent respondents hours
respondent per response
Measures for all grantees ................. Grantee program staff—all ............... 106 1 7 742
Participant-level measures ............... Grantee program staff—Tier 1 C/D, 45 1 1 45
Tier 2, and PREIS.
Perceived impact questions .............. Youth participants—PREIS .............. 2,000 1 5/60 167
Perceived impact measures ............. Grantee program staff—PREIS ........ 11 1 3 33
Total ........................................... ........................................................... ........................ ........................ ........................ 987
Terry S. Clark, collection assigned OMB control Health, Office for Human Research
Asst Information Collection Clearance number 0990–0260, which expires on Protections.
Officer. April 30, 2015. Prior to submitting that OMB No.: 0990–0260.
[FR Doc. 2015–08960 Filed 4–17–15; 8:45 am] ICR to OMB, OS seeks comments from Abstract: The information collected
BILLING CODE 4168–11–P the public regarding the burden through the Protection of Human
estimate, below, or any other aspect of Subjects: Assurance.
the ICR. Identification/IRB Certification/
DEPARTMENT OF HEALTH AND DATES: Comments on the ICR must be Declaration of Exemption Form
HUMAN SERVICES received on or before May 20, 2015. Protection of Human Subjects:
Assurance of Compliance with Federal
[Document Identifier: HHS–0990–0260–30D] ADDRESSES: Submit your comments to
Policy/IRB Review/IRB Recordkeeping/
Information.CollectionClearance
Informed Consent/Consent
Agency Information Collection @hhs.gov or by calling (202) 690–6162.
Documentation collection requirement
Activities; Proposed Collection; Public FOR FURTHER INFORMATION CONTACT: is the minimum necessary to satisfy the
Comment Request Information Collection Clearance staff, assurance, certification, reporting,
AGENCY: Office of the Assistant Information.CollectionClearance disclosure, documentation and
Secretary for Health, HHS. @hhs.gov or (202) 690–6162. recordkeeping requirements of Section
ACTION: Notice. SUPPLEMENTARY INFORMATION: When 491(a) of the Public Health Service Act
submitting comments or requesting and HHS Regulations for the protection
SUMMARY: In compliance with section information, please include the of human subjects at 45 CFR part 46.
3506(c)(2)(A) of the Paperwork document identifier 0990–0260 for Likely Respondents: Research
Reduction Act of 1995, the Office of the reference. institutions engaged in HHS-conducted
Secretary, Department of Health and Information Collection Request Title: or -supported research involving human
Human Services (HHS), announces Protection of Human Subjects: subjects. Institutional use of the form is
plans to submit an Information Assurance of Compliance with Federal also relied upon by other federal
Collection Request (ICR), described Policy/IRB Review/IRB Recordkeeping/ departments and agencies that have
below, to the Office of Management and Informed Consent/Consent codified or follow the Federal Policy for
Budget (OMB). The ICR is for extending Documentation—Extension OMB No. the Protection of Human Subjects
the use of the approved information 0990–0260, Assistant Secretary for (Common Rule).
TOTAL ESTIMATED ANNUALIZED BURDEN—HOURS
Average
Number of
Number of burden Total burden
Title responses per
respondents per response hours
respondent (in hours)
mstockstill on DSK4VPTVN1PROD with NOTICES
.103(b)(4), .109(d)IRB Actions, .116 and .117 Informed Consent .................. 6,000 39.33 1 235,980
.115(a) IRB Recordkeeping ............................................................................. 6,000 15 10 900,000
.103(b)(5) Incident Reporting, .113 Suspension or Termination Reporting .... 6,000 0.5 45/60 2,250
Total .......................................................................................................... ........................ ........................ ........................ 1,138,230
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Document Created: 2018-02-21 10:12:55
Document Modified: 2018-02-21 10:12:55
| 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 May 20, 2015. | |
| Contact | Information Collection Clearance staff, [email protected] or (202) 690-6162. | |
| FR Citation | 80 FR 21744 |
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