80 FR 46589 - Submission for OMB Review; 30 Day Comment Request; Post-Award Reporting Requirements Including Research Performance Progress Report Collection (OD/OPERA)
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health Federal Register Volume 80, Issue 150 (August 5, 2015)
National Institutes of Health
Federal Register Volume 80, Issue 150 (August 5, 2015)
| Page Range | 46589-46591 | |
| FR Document | 2015-19253 |
[Federal Register Volume 80, Number 150 (Wednesday, August 5, 2015)] [Notices] [Pages 46589-46591] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-19253] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Submission for OMB Review; 30 Day Comment Request; Post-Award Reporting Requirements Including Research Performance Progress Report Collection (OD/OPERA) SUMMARY: Under the provisions of section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Institutes of Health (NIH) has submitted to the Office of Management and Budget (OMB) a request for review and approval of the information collection [[Page 46590]] listed below. This proposed information collection was previously published in the Federal Register on March 16, 2015, Volume 80, No. 50, pages 13568-13569 and allowed 60 days for public comment. No public comments were received. The purpose of this notice is to allow an additional 30 days for public comment. The NIH may not conduct or sponsor, and the respondent is not required to respond to, an information collection that has been extended, revised, or implemented on or after October 1, 1995, unless it displays a currently valid OMB control number. Direct Comments to OMB: Written comments and/or suggestions regarding the item(s) contained in this notice, especially regarding the estimated public burden and associated response time, should be directed to the: Office of Management and Budget, Office of Regulatory Affairs, OIRA_submission@omb.eop.gov or by fax to 202-395-6974, Attention: Desk Officer for NIH. Comments Due Date: Comments regarding this information collection are best assured of having their full effect if received within 30 days of the date of this publication. FOR FURTHER INFORMATION CONTACT: To request more information on the proposed project or to obtain a copy of the data collection plans and instruments, contact: Ms. Mikia Currie, Division of Grants Policy, Office of Policy for Extramural Research Administration, NIH, Rockledge 1 Building, Room 3505, 6705 Rockledge Drive, Bethesda, MD 20892-7974, or call non-toll-free number (301) 435-0941, or Email your request, including your address to: ProjectClearanceBranch@mail.nih.gov. Proposed Collection: Public Health Service (PHS) Post-award Reporting Requirements. Revision, OMB 0925-0002, Expiration Date 8/31/ 2015. Form numbers: PHS 2590, PHS 416-7, PHS 2271, PHS 3734, PHS 6031- 1, and HHS 568. Need and Use of Information Collection: The RPPR is now required to be used by all NIH, Food and Drug Administration, Centers for Disease Control and Prevention, and Agency for Healthcare Research and Quality (AHRQ) grantees. Interim progress reports are required to continue support of a PHS grant for each budget year within a competitive segment. The phased transition to the RPPR required the maintenance of dual reporting processes for a period of time. Continued use of the PHS Non-competing Continuation Progress Report (PHS 2590), exists for a small group of grantees. This collection also includes other PHS post- award reporting requirements: PHS 416-7 NRSA Termination Notice, PHS 2271 Statement of Appointment, 6031-1 NRSA Annual Payback Activities Certification, HHS 568 Final Invention Statement and Certification, Final Progress Report instructions, iEdison, and PHS 3734 Statement Relinquishing Interests and Rights in a PHS Research Grant. The PHS 416-7, 2271, and 6031-1 are used by NRSA recipients to activate, terminate, and provide for payback of a NRSA. Closeout of an award requires a Final Invention Statement (HHS 568) and Final Progress Report. iEdison allows grantees and federal agencies to meet statutory requirements for reporting inventions and patents. The PHS 3734 serves as the official record of grantee relinquishment of a PHS award when an award is transferred from one grantee institution to another. The SBIR/ STTR Life Cycle Certifications are completed by small business grantees once certain milestones are reached during the project period. Pre- award reporting requirements are simultaneously consolidated under 0925-0001. OMB approval is requested for 3 years. There are no costs to respondents other than their time. The total estimated annualized burden hours are 531,802. Estimated Annualized Burden Hours ---------------------------------------------------------------------------------------------------------------- Average Number of Number of burden per Total annual Information collection forms respondents responses per response (in burden hours respondent hours) ---------------------------------------------------------------------------------------------------------------- Reporting ---------------------------------------------------------------------------------------------------------------- PHS 416-7....................................... 12,580 1 30/60 6,290 PHS 6031-1...................................... 1,778 1 20/60 593 PHS 568......................................... 11,180 1 5/60 932 iEdison......................................... 5,697 1 15/60 1,424 PHS 2271........................................ 22,035 1 15/60 5,509 PHS 2590........................................ 243 1 15 3,645 RPPR............................................ 32,098 1 15 481,470 Biosketch....................................... 2,544 1 2 5,088 Data Tables..................................... 758 1 4 3,032 PHS Inclusion Enrollment Report................. 2,544 1 1 2,544 Trainee Diversity Report........................ 480 1 15/60 120 Publication Reporting........................... 32,341 3 5/60 8,085 PHS 3734........................................ 479 1 30/60 240 Final Progress Report........................... 11,125 1 1 11,125 SBIR/STTR Phase II Final Progress Report........ 1,330 1 1 1,330 --------------------------------------------------------------- Reporting Burden Total...................... .............. .............. .............. 531,427 ---------------------------------------------------------------------------------------------------------------- Recordkeeping ---------------------------------------------------------------------------------------------------------------- SBIR/STTR Life Cycle Certification.............. 1,500 1 15/60 375 --------------------------------------------------------------- Grand Total............................. .............. .............. .............. 531,802 ---------------------------------------------------------------------------------------------------------------- [[Page 46591]] Dated: July 29, 2015. Lawrence A. Tabak, Deputy Director, National Institutes of Health. [FR Doc. 2015-19253 Filed 8-4-15; 8:45 am] BILLING CODE 4140-01-P
![Federal Register / Vol. 80, No. 150 / Wednesday, August 5, 2015 / Notices 46589
professionals. In May 2011, FDA III. Paperwork Reduction Act of 1995 Date: November 4, 2015.
convened a joint meeting of the Time: 8:30 a.m. to 4:00 p.m.
This guidance refers to a previously Agenda: Strategic Discussion of NCI’s
Nonprescription Drugs Advisory approved collection of information Clinical and Translational Research
Committee and the Pediatric Advisory found in FDA regulations. The Programs.
Committee to discuss the use of collection of information is subject to Place: National Institutes of Health,
acetaminophen in children. Shortly review by the Office of Management and Building 31, C-Wing, 6th Floor, Room 10, 31
before the meeting, the Consumer Budget (OMB) under the Paperwork Center Drive, Bethesda, MD 20892.
Healthcare Products Association Reduction Act of 1995 (PRA) (44 U.S.C. Contact Person: Sheila A. Prindiville, MD,
(CHPA) proposed to voluntarily phase MPH, Director, Coordinating Center for
3501–3520). The collection of
out all of the existing single-ingredient Clinical Trials, National Institutes of Health,
information referenced in this guidance National Cancer Institute, 9609 Medical
concentrated drop formulations of the that pertain to the format and content Center Drive, Room 6W136, Rockville, MD
OTC, pediatric, oral, liquid requirements for OTC drug product 20850, 240–276–6173, prindivs@
acetaminophen drug products and labeling (§ 201.66) have been approved mail.nih.gov.
market only the 160 mg/5 mL. At the under OMB control number 0910–0340. Any interested person may file written
Advisory Committee meeting, FDA took The labeling requirements in § 201.326 comments with the committee by forwarding
note of CHPA’s voluntary transition to are not subject to review by OMB the statement to the Contact Person listed on
a single concentration of pediatric oral this notice. The statement should include the
because they do not constitute a
liquid acetaminophen. name, address, telephone number and when
‘‘collection of information’’ under the applicable, the business or professional
In response to CHPA’s voluntary PRA. Rather, the labeling statements are
transition to a single concentration of affiliation of the interested person.
a ‘‘public disclosure of information In the interest of security, NIH has
OTC oral liquid acetaminophen originally supplied by the Federal instituted stringent procedures for entrance
products, FDA published a Drug Safety government to the recipient for the onto the NIH campus. All visitor vehicles,
Communication on December 22, 2011, purpose of disclosure to the public’’ (5 including taxicabs, hotel, and airport shuttles
to inform the public of the 160 mg/5 mL CFR 1320.3(c)(2)). will be inspected before being allowed on
concentration now marketed for campus. Visitors will be asked to show one
children ages 2 to 3 years and to IV. Electronic Access form of identification (for example, a
recommend that end users of the government-issued photo ID, driver’s license,
Persons with access to the Internet
product read the Drug Facts label to or passport) and to state the purpose of their
may obtain the document at either visit.
identify the concentration of the oral http://www.fda.gov/Drugs/Guidance Information is also available on the
liquid acetaminophen, dosage, and ComplianceRegulatoryInformation/ Institute’s/Center’s home page: http://
directions for use. Guidances/default.htm or http:// deainfo.nci.nih.gov/advisory/ctac/ctac.htm,
FDA issued the draft guidance on www.regulations.gov. where an agenda and any additional
October 8, 2014 (79 FR 60854), to information for the meeting will be posted
address ongoing concerns about the Dated: July 30, 2015.
when available.
potential for acetaminophen overdose Leslie Kux,
(Catalogue of Federal Domestic Assistance
associated with these products and to Associate Commissioner for Policy. Program Nos. 93.392, Cancer Construction;
encourage safer use. Comments on the [FR Doc. 2015–19178 Filed 8–4–15; 8:45 am] 93.393, Cancer Cause and Prevention
draft guidance were considered while BILLING CODE 4164–01–P Research; 93.394, Cancer Detection and
finalizing this guidance, which has been Diagnosis Research; 93.395, Cancer
revised and clarified in some respects. Treatment Research; 93.396, Cancer Biology
This guidance is being issued DEPARTMENT OF HEALTH AND Research; 93.397, Cancer Centers Support;
HUMAN SERVICES 93.398, Cancer Research Manpower; 93.399,
consistent with FDA’s good guidance Cancer Control, National Institutes of Health,
practices regulation (21 CFR 10.115). HHS)
The guidance represents the current National Institutes of Health
thinking of FDA on addressing safety Dated: July 31, 2015.
National Cancer Institute; Notice of David Clary,
achieved through drug product design Open Meeting
and labeling to minimize medication Program Analyst, Office of Federal Advisory
errors. It does not establish any rights Pursuant to section 10(a) of the Committee Policy.
for any person and is not binding on Federal Advisory Committee Act, as [FR Doc. 2015–19193 Filed 8–4–15; 8:45 am]
FDA or the public. You can use an amended (5 U.S.C. App.), notice is BILLING CODE 4140–01–P
alternative approach if it satisfies the hereby given of a meeting of the
requirements of the applicable statutes National Cancer Institute Clinical Trials
and regulations. and Translational Research Advisory DEPARTMENT OF HEALTH AND
Committee. HUMAN SERVICES
II. Comments The meeting will be open to the
Interested persons may submit either public, with attendance limited to space National Institutes of Health
electronic comments regarding this available. Individuals who plan to
Submission for OMB Review; 30 Day
document to http://www.regulations.gov attend and need special assistance, such
Comment Request; Post-Award
or written comments to the Division of as sign language interpretation or other
Reporting Requirements Including
Dockets Management (see ADDRESSES). It reasonable accommodations, should
Research Performance Progress
is only necessary to send one set of notify the Contact Person listed below
asabaliauskas on DSK5VPTVN1PROD with NOTICES
Report Collection (OD/OPERA)
comments. Identify comments with the in advance of the meeting. The meeting
docket number found in brackets in the will also be videocast and can be SUMMARY: Under the provisions of
heading of this document. Received accessed from the NIH Videocasting and section 3507(a)(1)(D) of the Paperwork
comments may be seen in the Division Podcasting Web site (http://videocast. Reduction Act of 1995, the National
of Dockets Management between 9 a.m. nih.gov/). Institutes of Health (NIH) has submitted
and 4 p.m., Monday through Friday, and Name of Committee: National Cancer to the Office of Management and Budget
will be posted to the docket at http:// Institute Clinical Trials and Translational (OMB) a request for review and
www.regulations.gov. Research Advisory Committee. approval of the information collection
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![Federal Register / Vol. 80, No. 150 / Wednesday, August 5, 2015 / Notices 46591
Dated: July 29, 2015. Any interested person may file written Institute on Aging, Gateway Building, 7201
Lawrence A. Tabak, comments with the committee by forwarding Wisconsin Avenue, Suite 2C212, Bethesda,
the statement to the Contact Person listed on MD 20892, 301–402–7703, cmoten@
Deputy Director, National Institutes of Health.
this notice. The statement should include the mail.nih.gov.
[FR Doc. 2015–19253 Filed 8–4–15; 8:45 am] name, address, telephone number and when (Catalogue of Federal Domestic Assistance
BILLING CODE 4140–01–P applicable, the business or professional Program Nos. 93.866, Aging Research,
affiliation of the interested person. National Institutes of Health, HHS)
In the interest of security, NIH has
DEPARTMENT OF HEALTH AND instituted stringent procedures for entrance Dated: July 31, 2015.
HUMAN SERVICES onto the NIH campus. All visitor vehicles, David Clary,
including taxicabs, hotel, and airport shuttles Program Analyst, Office of Federal Advisory
National Institutes of Health will be inspected before being allowed on Committee Policy.
campus. Visitors will be asked to show one [FR Doc. 2015–19192 Filed 8–4–15; 8:45 am]
National Center for Complementary form of identification (for example, a
BILLING CODE 4140–01–P
and Integrative Health; Notice of government-issued photo ID, driver’s license,
Meeting or passport) and to state the purpose of their
visit.
Information is also available on the DEPARTMENT OF HEALTH AND
Pursuant to section 10(d) of the
Institute’s/Center’s home page: https:// HUMAN SERVICES
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is nccih.nih.gov/about/naccih, where an agenda
and any additional information for the National Institutes of Health
hereby given of a meeting of the meeting will be posted when available.
National Advisory Council for Submission for OMB Review; 30 Day
(Catalogue of Federal Domestic Assistance
Complementary and Integrative Health. Program Nos. 93.213, Research and Training Comment Request; PHS Applications
The meeting will be open to the in Complementary and Alternative Medicine, and Pre-Award Reporting
public as indicated below, with National Institutes of Health, HHS) Requirements (OD/OPERA)
attendance limited to space available.
Dated: July 30, 2015. SUMMARY: Under the provisions of
Individuals who plan to attend and
Michelle Trout, Section 3507(a)(1)(D) of the Paperwork
need special assistance, such as sign
language interpretation or other Program Analyst, Office of Federal Advisory Reduction Act (PRA) of 1995, the Office
Committee Policy. of the Director (OD), Office of
reasonable accommodations, should
notify the Contact Person listed below [FR Doc. 2015–19174 Filed 8–4–15; 8:45 am] Extramural Research (OER), the
in advance of the meeting. BILLING CODE 4140–01–P National Institutes of Health (NIH) has
The meeting will be closed to the submitted to the Office of Management
public in accordance with the and Budget (OMB) a request for review
DEPARTMENT OF HEALTH AND and approval of the information
provisions set forth in sections
HUMAN SERVICES collection listed below. This proposed
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and information collection was previously
National Institutes of Health published in the Federal Register on
the discussions could disclose
confidential trade secrets or commercial March 16, 2015, Volume 80, No. 50,
National Institute on Aging; Notice of
property such as patentable material, pages 13567–13568 and allowed 60 days
Closed Meeting
and personal information concerning for public comment. No public
individuals associated with the grant Pursuant to section 10(d) of the comments were received. The purpose
applications, the disclosure of which Federal Advisory Committee Act, as of this notice is to allow an additional
would constitute a clearly unwarranted amended (5 U.S.C. App.), notice is 30 days for public comment. The NIH
invasion of personal privacy. hereby given of the following meeting. may not conduct or sponsor, and the
The meeting will be closed to the respondent is not required to respond
Name of Committee: National Advisory public in accordance with the to, an information collection that has
Council for Complementary and Integrative provisions set forth in sections been extended, revised, or implemented
Health.
Date: August 26, 2015.
552b(c)(4) and 552b(c)(6), Title 5 U.S.C., on or after October 1, 1995, unless it
Open: 1:00 p.m. to 1:15 p.m. as amended. The grant applications and displays a currently valid OMB control
Agenda: Concept Review—Mechanistic the discussions could disclose number.
Studies of Complementary and Integrative confidential trade secrets or commercial Direct Comments to OMB: Written
Mind and Body and Body Interventions property such as patentable material, comments and/or suggestions regarding
Supported by NCCIH. and personal information concerning the item(s) contained in this notice,
Place: National Institutes of Health, Two individuals associated with the grant especially regarding the estimated
Democracy Plaza, 6707 Democracy applications, the disclosure of which public burden and associated response
Boulevard, Bethesda, MD 20892 (Telephone would constitute a clearly unwarranted time should be sent via email to
Conference Call).
Closed: 1:20 p.m. to 2:00 p.m.
invasion of personal privacy. OIRA_submission@omb.eop.gov or by
Agenda: To review and evaluate grant Name of Committee: National Institute on fax to 202–395–6974, Attention: Desk
applications. Aging Special Emphasis Panel; Albert Officer for NIH.
Place: National Institutes of Health, Two Einstein Aging Study. Comments Due Date: Comments
Democracy Plaza, 6707 Democracy Date: September 17, 2015. regarding this information collection are
asabaliauskas on DSK5VPTVN1PROD with NOTICES
Boulevard, Bethesda, MD 20892 (Telephone Time: 1:00 p.m. to 4:00 p.m. best assured of having their full effect if
Conference Call). Agenda: To review and evaluate grant received within 30 days of the date of
Contact Person: Martin H. Goldrosen, applications. this publication.
Ph.D., Director, Division of Extramural Place: National Institute on Aging,
FOR FURTHER INFORMATION CONTACT: To
Activities, National Center for Gateway Building, Suite 2C212, 7201
Complementary and Integrative Health, NIH, Wisconsin Avenue, Bethesda, MD 20892 request more information on the
6707 Democracy Blvd., Ste. 401, Bethesda, (Telephone Conference Call). proposed project or to obtain a copy of
MD 20892–5475, (301) 594–2014, goldrosm@ Contact Person: Carmen Moten, MPH, the data collection plans and
mail.nih.gov. Ph.D., Scientific Review Officer, National instruments, contact Ms. Mikia Currie,
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Document Created: 2018-02-23 10:53:05
Document Modified: 2018-02-23 10:53:05
| 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 | |
| Dates | Comments regarding this information collection are best assured of having their full effect if received within 30 days of the date of this publication. | |
| Contact | To request more information on the proposed project or to obtain a copy of the data collection plans and instruments, contact: Ms. Mikia Currie, Division of Grants Policy, Office of Policy for Extramural Research Administration, NIH, Rockledge 1 Building, Room 3505, 6705 Rockledge Drive, Bethesda, MD 20892-7974, or call non-toll-free number (301) 435-0941, or Email your request, | |
| FR Citation | 80 FR 46589 |
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