81 FR 64928 - National Center for Advancing Translational Sciences; Notice of Closed Meeting
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health Federal Register Volume 81, Issue 183 (September 21, 2016)
National Institutes of Health
Federal Register Volume 81, Issue 183 (September 21, 2016)
| Page Range | 64928-64929 | |
| FR Document | 2016-22669 |
[Federal Register Volume 81, Number 183 (Wednesday, September 21, 2016)] [Notices] [Pages 64928-64929] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-22669] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Center for Advancing Translational Sciences; Notice of Closed Meeting Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meeting. The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The contract proposals and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the contract proposals, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. Name of Committee: National Center for Advancing Translational Sciences Special Emphasis Panel; TRND2. Date: October 13, 2016. Time: 11:30 a.m. to 6:30 p.m. Agenda: To review and evaluate contract proposals. Place: National Institutes of Health, Room 1087, 6701 Democracy Blvd., Bethesda, MD 20892 (Telephone Conference Call). Contact Person: Victor Henriquez, Ph.D., Scientific Review Officer, Office of Scientific Director, National Center for Advancing Translational Sciences (NCATS), National Institutes of Health, 6701 Democracy Blvd., Democracy 1, Room 1080, Bethesda, MD 20892-4878, 301-451-2405, [email protected]. (Catalogue of Federal Domestic Assistance Program Nos. 93.859, Pharmacology, Physiology, and Biological Chemistry Research; 93.350, B--Cooperative Agreements; 93.859, Biomedical Research and Research Training, National Institutes of Health, HHS) [[Page 64929]] Dated: September 15, 2016. David Clary, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2016-22669 Filed 9-20-16; 8:45 am] BILLING CODE 4140-01-P
![64928 Federal Register / Vol. 81, No. 183 / Wednesday, September 21, 2016 / Notices
In addition, informed consent Responsible Party. In the policy, the 45 CFR 75.371 and/or other authorities,
documents for clinical trials within all awardee or the investigator is as appropriate. If the NIH-funded
three categories are to include a specific responsible for meeting the expectations clinical trial is also an applicable
statement relating to posting of clinical of this policy. In the regulation, a clinical trial, non-compliance with the
trial information at ClinicalTrials.gov. ‘‘responsible party’’ means, in part, requirements specified in 42 U.S.C.
Each NIH-funded clinical trial should ‘‘with respect to a clinical trial, the 282(j) and 42 CFR part 11 may also lead
have only one entry in sponsor of the clinical trial, as defined to the actions described in 42 CFR
ClinicalTrials.gov that contains its in 21 CFR 50.3 (or any successor 11.66.
registration and results information. regulation); or the principal investigator
Awardees and investigators need not of such clinical trial if so designated by Effective Date
and should not create a separate record a sponsor, grantee, contractor, or This policy is effective January 18,
of the applicable clinical trial to comply awardee, so long as the principal 2017.
with this policy. investigator is responsible for Date: September 12, 2016.
The NIH will publicly post conducting the trial, has access to and
registration information and results Francis S. Collins,
control over the data from the clinical
information in ClinicalTrials.gov. Director, National Institutes of Health.
trial, has the right to publish the results
of the trial, and has the ability to meet [FR Doc. 2016–22379 Filed 9–16–16; 11:15 am]
Definitions
all of the requirements under [42 CFR BILLING CODE 4140–01–P
Clinical Trial. For purposes of this part 11] for the submission of clinical
policy, a ‘‘clinical trial’’ means ‘‘a trial information.’’ 6
research study in which one or more Primary Completion Date. In the DEPARTMENT OF HEALTH AND
human subjects are prospectively policy, this term has the same meaning HUMAN SERVICES
assigned to one or more interventions as the term ‘‘primary completion date’’
(which may include placebo or other National Institutes of Health
in the regulation, which is ‘‘the date that
control) to evaluate the effects of those the final subject was examined or
interventions on health-related National Center for Advancing
received an intervention for the Translational Sciences; Notice of
biomedical or behavioral outcomes.’’ 3 purposes of final collection of data for
This definition encompasses phase 1 Closed Meeting
the primary outcome, whether the
trials of FDA-regulated drug and clinical trial concluded according to the Pursuant to section 10(d) of the
biological products, small feasibility pre-specified protocol or was Federal Advisory Committee Act, as
studies of FDA-regulated device terminated.’’ 7 amended (5 U.S.C. App.), notice is
products, and studies of any Registration Information. In the hereby given of the following meeting.
intervention not regulated by the FDA, policy, this term has the same meaning The meeting will be closed to the
e.g., behavioral interventions. This as the term ‘‘registration information’’ in public in accordance with the
definition of ‘‘clinical trial’’ 4 is broader the regulation. In the regulation, provisions set forth in sections
than the term ‘‘applicable clinical trial’’ registration information consists of 552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as defined in the regulation.5 descriptive information, recruitment as amended. The contract proposals and
information, location and contact the discussions could disclose
3 Further information about this definition is
information, and administrative data.8 confidential trade secrets or commercial
available from the NIH Office of Science Policy at
http://osp.od.nih.gov/office-clinical-research-and- Results Information. In the policy, property such as patentable material,
bioethics-policy/clinical-research-policy/clinical- this term has the same meaning as the and personal information concerning
trials. term ‘‘results information’’ in the individuals associated with the contract
4 Note that the regulation also includes a
regulation. In the regulation, results proposals, the disclosure of which
definition of ‘‘clinical trial.’’ That definition is ‘‘a
clinical investigation or a clinical study in which
information includes participant flow, would constitute a clearly unwarranted
human subject(s) are prospectively assigned, demographic and baseline invasion of personal privacy.
according to a protocol, to one or more characteristics, outcomes and statistical
interventions (or no intervention) to evaluate the Name of Committee: National Center for
analyses, adverse events, the protocol
effect(s) of the intervention(s) on biomedical or Advancing Translational Sciences Special
health related outcomes’’ (see 42 CFR 11.10 (a)). For
and statistical analysis plan, and Emphasis Panel; TRND2.
the purposes of this policy, the regulatory definition administrative information.9 Date: October 13, 2016.
and the definition in this policy are treated as Time: 11:30 a.m. to 6:30 p.m.
synonymous.
Compliance
Agenda: To review and evaluate contract
5 In the regulation, applicable clinical trial is
If the clinical trial is NIH-funded in proposals.
defined as an applicable device clinical trial or an whole or in part, expectations for Place: National Institutes of Health, Room
applicable drug clinical trial. The regulation defines
an applicable device clinical trial to mean, in part, clinical trial registration and summary 1087, 6701 Democracy Blvd., Bethesda, MD
‘‘a prospective clinical study of health outcomes results submission will be included in 20892 (Telephone Conference Call).
comparing an intervention with a device product the terms and conditions of the award. Contact Person: Victor Henriquez, Ph.D.,
subject to section 510(k), 515, or 520(m) of the Failure to comply with the terms and Scientific Review Officer, Office of Scientific
Federal Food, Drug, and Cosmetic Act (21 U.S.C. Director, National Center for Advancing
360(k), 21 U.S.C. 360e, 21 U.S.C. 360j(m)) against conditions of the NIH award may
Translational Sciences (NCATS), National
a control in human subjects (other than a small provide a basis for enforcement actions, Institutes of Health, 6701 Democracy Blvd.,
clinical trial to determine the feasibility of a device including termination, consistent with Democracy 1, Room 1080, Bethesda, MD
product, or a clinical trial to test prototype device
products where the primary outcome measure
20892–4878, 301–451–2405, henriquv@
mstockstill on DSK3G9T082PROD with NOTICES
meaning given in 21 CFR 312.3 (or any successor mail.nih.gov.
relates to feasibility and not to health outcomes).’’
regulation) and ‘‘phase 1’’ has the meaning given in
The regulation defines an applicable drug clinical (Catalogue of Federal Domestic Assistance
21 CFR 312.21 (or any successor regulation).’’
trial to mean, in part, ‘‘a controlled clinical 6 See 42 CFR 11.10 (a) and 42 CFR 11.4. Program Nos. 93.859, Pharmacology,
investigation, other than a phase 1 clinical
investigation, of a drug product subject to section
7 See the complete definition at 42 CFR 11.10 (a). Physiology, and Biological Chemistry
505 of the Federal Food, Drug, and Cosmetic Act 8 See 42 CFR 11.10 (b) and 42 CFR 11.28 for the Research; 93.350, B—Cooperative
(21 U.S.C. 355) or a biological product subject to specific data elements. Agreements; 93.859, Biomedical Research
section 351 of the Public Health Service Act (42 9 See 42 CFR 11.28 for complete results and Research Training, National Institutes of
U.S.C. 262), where ‘‘clinical investigation’’ has the information and specific data elements. Health, HHS)
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![Federal Register / Vol. 81, No. 183 / Wednesday, September 21, 2016 / Notices 64929
Dated: September 15, 2016. number through TTY by calling the toll- demonstration is testing the alternative
David Clary, free Federal Relay Service at (800) 877– approach of setting FMRs at the ZIP
Program Analyst, Office of Federal Advisory 8339. Code level. The core hypothesis is that
Committee Policy. FOR FURTHER INFORMATION CONTACT: this will significantly expand the ability
[FR Doc. 2016–22669 Filed 9–20–16; 8:45 am] Anna P. Guido, Reports Management of Housing Choice Vouchers (HCV)
BILLING CODE 4140–01–P Officer, QDAM, Department of Housing holders to access housing in
and Urban Development, 451 7th Street neighborhoods with high-quality
SW., Washington, DC 20410; email schools, low crime rates, and other
DEPARTMENT OF HOUSING AND Anna P. Guido at Anna.P.Guido@ indicators of opportunity, as well as
URBAN DEVELOPMENT hud.gov or telephone (202) 402–5535. integrated neighborhoods in furtherance
This is not a toll-free number. Persons of HUD’s goal of affirmatively furthering
[Docket No. FR–5915–N–10] fair housing.
with hearing or speech impairments
60-Day Notice of Proposed Information may access this number through TTY by HUD is evaluating the SAFMR
Collection: Small Area Fair Market calling the toll-free Federal Relay demonstration and an important
Rent Demonstration Evaluation Service at (800) 877–8339. consideration in this evaluation is how
Copies of available documents voucher holders and landlords perceive
AGENCY: Office of Policy Development submitted to OMB may be obtained the shift from traditional area-wide
and Research, HUD. from Ms. Guido. FMRs to SAFMRs. HUD will look into
ACTION: Notice. SUPPLEMENTARY INFORMATION: This whether both existing and new voucher
notice informs the public that HUD is holders understood how the change to
SUMMARY: HUD is seeking approval from seeking approval from OMB for the using SAFMRs affected their housing
the Office of Management and Budget information collection described in options and whether it led movers to
(OMB) for the information collection Section A. search in new neighborhoods or affected
described below. In accordance with the Copies of available documents the rate of moving of existing voucher
Paperwork Reduction Act, HUD is submitted to OMB may be obtained holders. Similarly, HUD wants to know
requesting comment from all interested from Ms. Guido. whether landlords were aware of the
parties on the proposed collection of
SUPPLEMENTARY INFORMATION: This change in the HCV program and
information. The purpose of this notice
notice informs the public that HUD is whether this affected their willingness
is to allow for 60 days of public
seeking approval from OMB for the to rent to voucher holders and the level
comment.
information collection described in at which they set rents. In order to
DATES: Comments Due Date: November Section A. address these perceptions, 70 tenants
21, 2016. and 35 landlords will be interviewed in
ADDRESSES: Interested persons are
A. Overview of Information Collection the areas served by the five PHAs that
invited to submit comments regarding Title of Information Collection: Small are in the SAFMR demonstration:
this proposal. Comments should refer to Area Fair Market Rent Demonstration Housing Authority of Cook County (IL);
the proposal by name and/or OMB Evaluation. Housing Authority of the City of Long
Control Number and should be sent to: OMB Approval Number: N/A. Beach (CA); Chattanooga (TN) Housing
Anna P. Guido, Reports Management Type of Request: New. Authority; Town of Mamaroneck (NY)
Officer, QDAM, Department of Housing Description of the need for the Housing Authority; Housing Authority
and Urban Development, 451 7th Street information and proposed use: HUD of the City of Laredo (TX); and two
SW., Room 4176, Washington, DC generally publishes a single FMR for PHAs from the Dallas metropolitan
20410–5000; telephone (202) 402–5534 each metropolitan area and provides area—Dallas Housing Authority (TX),
(this is not a toll-free number) or email public housing agencies with discretion and the Plano Housing Authority (TX).
at Anna.P.Guido@hud.gov for a copy of to vary local voucher payment standards To build rapport during recruitment, by
the proposed forms or other available between 90 and 110 percent of the Fair acknowledging the value of their time,
information. Persons with hearing or Market Rent (FMR) (unless HUD an incentive payment of $20 for tenants
speech impairments may access this approves an exception). The SAFMR and $40 for landlords will be made.
Number of Frequency of Responses Burden hour Annual burden Cost per
Information collection Annual cost
respondents response per annum per response hours response
Tenants ........................ 70 1 1 0.5 35 $20 $1,400
Landlords ..................... 35 1 1 1 35 40 1,400
Total ...................... 105 ........................ ........................ ........................ 70 ........................ 2,800
B. Solicitation of Public Comment (2) The accuracy of the agency’s information technology, e.g., permitting
This notice is soliciting comments estimate of the burden of the proposed electronic submission of responses.
from members of the public and affected collection of information; HUD encourages interested parties to
parties concerning the collection of (3) Ways to enhance the quality, submit comment in response to these
mstockstill on DSK3G9T082PROD with NOTICES
information described in Section A on utility, and clarity of the information to questions.
the following: be collected; and
Authority: Section 3507 of the Paperwork
(1) Whether the proposed collection (4) Ways to minimize the burden of
Reduction Act of 1995, 44 U.S.C. Chapter 35.
of information is necessary for the the collection of information on those
proper performance of the functions of who are to respond; including through
the agency, including whether the the use of appropriate automated
information will have practical utility; collection techniques or other forms of
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Document Created: 2016-09-21 01:30:55
Document Modified: 2016-09-21 01:30:55
| 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 | |
| Dates | October 13, 2016. | |
| FR Citation | 81 FR 64928 |
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