Federal Register / Vol. 82, No. 211 / Thursday, November 2, 2017 / Notices 50887 

are set forth in 21 CFR 314.50, and 

approved under OMB control number 

0910–0001. This information collection 

supports part 315, currently approved 

under OMB control number 0910–0409. 

Based on past submissions (human 

drug applications and/or new indication 

supplements for diagnostic 

radiopharmaceuticals), we estimate two 

submissions will be received annually. 

We estimate the time needed to prepare 

a complete application for a diagnostic 

radiopharmaceutical to be 

approximately 10,000 hours, roughly 

one-fifth of which, or 2,000 hours, is 

estimated to be spent preparing the 

portions of the application that would 

be affected by these regulations. The 

regulations do not impose any 

additional reporting burden for safety 

and effectiveness information on 

diagnostic radiopharmaceuticals beyond 

the estimated burden of 2,000 hours 

because safety and effectiveness 

information is already required by 

§ 314.50 (collection of information 

approved under OMB control number 

0910–0001). In fact, clarification in 

these regulations of FDA’s criteria for 

evaluation of diagnostic 

radiopharmaceuticals is intended to 

streamline overall information 

collection burdens, particularly for 

diagnostic radiopharmaceuticals that 

may have well-established, low-risk 

safety profiles, by enabling 

manufacturers to tailor information 

submissions and avoid unnecessary 

clinical studies. 

FDA estimates the burden of this 

information collection as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

21 CFR section Number of 

respondents 

Number of 

responses 

per 

respondent 

Total annual 

responses 

Average 

burden per 

response 

(in hours) 

Total hours 

Diagnostic Radiopharmaceuticals—315.4, 315.5, and 315.6 ................. 2 1 2 2,000 4,000 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 

Table 1 contains estimates of the 

annual reporting burden for the 

preparation of the safety and 

effectiveness sections of an application 

that are imposed by the applicable 

regulations. This estimate does not 

include time needed to conduct studies 

and clinical trials or other research from 

which the reported information is 

obtained. 

Dated: October 27, 2017. 

Anna K. Abram, 

Deputy Commissioner for Policy, Planning, 

Legislation, and Analysis. 

[FR Doc. 2017–23836 Filed 11–1–17; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute of Nursing Research; 

Notice of Closed Meeting 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended, 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 grant applications and 

the discussions could disclose 

confidential trade secrets or commercial 

property such as patentable material, 

and personal information concerning 

individuals associated with the grant 

applications, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: National Institute of 

Nursing Research Special Emphasis Panel; 

NINR Clinical Trial Planning Grant. 

Date: November 17, 2017. 

Time: 1:00 p.m. to 3:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 

National Institute of Nursing Research, One 

Democracy Plaza, 6701 Democracy 

Boulevard, Room 703, Bethesda, MD 20892 

(Telephone Conference Call). 

Contact Person: Weiqun Li, MD, Scientific 

Review Officer, National Institute of Nursing 

Research, National Institutes of Health, 6701 

Democracy Boulevard, Room 710, Bethesda, 

MD 20892, (301) 594–5966, 

wli@mail.nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.361, Nursing Research, 

National Institutes of Health, HHS) 

Dated: October 30, 2017. 

Sylvia L. Neal, 

Program Analyst, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2017–23865 Filed 11–1–17; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Government-Owned Inventions; 

Availability for Licensing 

AGENCY: National Institutes of Health, 

HHS. 

ACTION: Notice. 

SUMMARY: The inventions listed below 

are owned by an agency of the U.S. 

Government and are available for 

licensing in the U.S. 

FOR FURTHER INFORMATION CONTACT: 

Licensing information and copies of the 

patent applications listed below may be 

obtained by emailing the indicated 

licensing contact Michael Shmilovich, 

shmilovm@nih.gov at the National 

Heart, Lung, and Blood, Office of 

Technology Transfer and Development 

Office of Technology Transfer, 31 Center 

Drive Room 4A29, MSC2479, Bethesda, 

MD 20892–2479; telephone: 301–402– 

5579. A signed Confidential Disclosure 

Agreement may be required to receive 

copies of the patent applications. 

SUPPLEMENTARY INFORMATION: This 

notice is in accordance with 35 U.S.C. 

209 and 37 CFR 404 to achieve 

commercialization of results of 

federally-funded research and 

development. Foreign patent 

applications are filed on selected 

inventions to extend market coverage 

for companies and may also be available 

for licensing. A description of the 

technology follows. 

Endo-Cameral Closure Device 

Description of Technology: Devices 

and methods for closing a hole in the 

wall of a cardiovascular structure from 

the inside using a self-assembling 

closure device. The closure device can 

be delivered to the subject hole from the 

inside of the cardiovascular chamber 

using a transcatheter approach. The 

methods are techniques involve 

deploying the closure device from the 

delivery device such that an endocameral portion of the closure device 

self-expands first to cover the hole from 

the inside, and then extra-cameral arms 

of the device are released to self-deploy 

against the outside of the wall by 


asabaliauskas on DSKBBXCHB2PROD with NOTICES
50888 Federal Register / Vol. 82, No. 211 / Thursday, November 2, 2017 / Notices 

withdrawal of a retaining element, such 

as a guidewire, to secure the closure 

device to the wall. 

Potential Commercial Applications: 

Endovascular interventions. 

Inventors: Toby Rogers, Merdim 

Sonmez, Robert Lederman, Ozgur 

Kocaturk, (NHLBI). 

Intellectual Property: HHS Reference 

No. E–273–2015/0, U.S. Provisional 

Patent Application 62/236,734 filed 

October 2, 2015, International Patent 

Application PCT/US2016/054961 filed 

September 30, 2016. 

Licensing Contact: Michael 

Shmilovich, Esq, CLP; 301–435–5019; 

shmilovm@nih.gov. 

Dated: October 23, 2017. 

Michael Shmilovich, 

Senior Licensing and Patenting Manager, 

National Heart, Lung, and Blood Institute, 

Office of Technology Transfer and 

Development. 

[FR Doc. 2017–23863 Filed 11–1–17; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Heart, Lung, and Blood 

Institute; Notice of Closed Meetings 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended, notice is hereby given of the 

NHLBI Special Emphasis Panel 

meetings. 

The meetings 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 grant applications and 

the discussions could disclose 

confidential trade secrets or commercial 

property such as patentable material, 

and personal information concerning 

individuals associated with the grant 

applications, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: National Heart, Lung, 

and Blood Institute Special Emphasis Panel; 

T32: Institutional Training to Promote 

Diversity. 

Date: November 30, 2017. 

Time: 11:00 a.m. to 12:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 6701 

Rockledge Drive, Suite 7189, Bethesda, MD 

20892 (Telephone Conference Call). 

Contact Person: Lindsay M. Garvin, Ph.D., 

Scientific Review Officer, Office of Scientific 

Review, National Heart, Lung, and Blood 

Institute, National Institutes of Health, 6701 

Rockledge Drive, Suite 7189, Bethesda, MD 

20892, 301–827–7911, lindsay.garvin@

nih.gov. 

Name of Committee: National Heart, Lung, 

and Blood Institute Special Emphasis Panel; 

National Heart, Lung, and Blood Institute— 

Factor VIII Immune Response (U54). 

Date: November 30–December 1, 2017. 

Time: 12:30 p.m. to 3:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: Crowne Plaza Hotel, 1480 Crystal 

Drive, Arlington, VA 22202. 

Contact Person: William J. Johnson, Ph.D., 

Scientific Review Officer, Office of Scientific 

Review/DERA, National Heart, Lung, and 

Blood Institute, 6701 Rockledge Drive, Room 

7178, Bethesda, MD 20892–7924, 301–827– 

7938, johnsonwj@nhlbi.nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.233, National Center for 

Sleep Disorders Research; 93.837, Heart and 

Vascular Diseases Research; 93.838, Lung 

Diseases Research; 93.839, Blood Diseases 

and Resources Research, National Institutes 

of Health, HHS) 

Dated: October 27, 2017. 

Michelle Trout, 

Program Analyst, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2017–23819 Filed 11–1–17; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute of Arthritis and 

Musculoskeletal and Skin Diseases; 

Notice of Closed Meeting 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended, 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 grant applications and 

the discussions could disclose 

confidential trade secrets or commercial 

property such as patentable material, 

and personal information concerning 

individuals associated with the grant 

applications, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: National Institute of 

Arthritis and Musculoskeletal and Skin 

Diseases Special Emphasis Panel; NIAMS 

Ancillary Studies Review Meeting. 

Date: November 15, 2017. 

Time: 10:00 a.m. to 12:30 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institute of Health/NIAMS, 

6701 Democracy Blvd., Suite 824, Bethesda, 

MD 20892 (Teleconference). 

Contact Person: Yin Liu, Ph.D., MD, 

Scientific Review Officer, Scientific Review 

Branch, National Institute of Health/NIAMS, 

6701 Democracy Blvd., Suite 824, Bethesda, 

MD 20892, 301–594–4952, liuy@

exchange.nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.846, Arthritis, 

Musculoskeletal and Skin Diseases Research, 

National Institutes of Health, HHS) 

Dated: October 30, 2017. 

Sylvia L. Neal, 

Program Analyst, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2017–23864 Filed 11–1–17; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HOUSING AND 

URBAN DEVELOPMENT 

[Docket No. FR–6044–N–01] 

Notice of Certain Operating Cost 

Adjustment Factors for 2018 

AGENCY: Office of the Assistant 

Secretary for Housing—Federal Housing 

Commissioner, HUD. 

ACTION: Notice. 

SUMMARY: This notice establishes 

operating cost adjustment factors 

(OCAFs) for project-based rental 

assistance contracts issued under 

Section 8 of the United States Housing 

Act of 1937 and renewed under the 

Multifamily Assisted Housing Reform 

and Affordability Act of 1997 (MAHRA) 

with an anniversary date on or after 

February 11, 2018. OCAFs are annual 

factors used primarily to adjust the rents 

for contracts renewed under section 515 

or section 524 of MAHRA. OCAFs are 

distinct from, and do not apply to the 

same properties as Annual Adjustment 

Factors (AAFs). AAFs are used to adjust 

contract rents for units assisted in 

certain Section 8 housing assistance 

payment programs during the initial 

(i.e., pre-renewal) term of the HAP 

contract and for all units in the ProjectBased Certificate program. 

DATES: Applicable: February 11, 2018. 

FOR FURTHER INFORMATION CONTACT: 

Carisa L. Janis, Program Analyst, Office 

of Asset Management and Portfolio 

Oversight, Department of Housing and 

Urban Development, 451 7th Street SW., 

Washington, DC 20410; telephone 

number 202–402–2487 (this is not a tollfree number). Hearing- or speechimpaired individuals may access this 

number through TTY by calling the tollfree Federal Relay Service at 800–877– 

8339. 

SUPPLEMENTARY INFORMATION: 

I. OCAFs 

Section 514(e)(2) and section 524(c)(1) 

of MAHRA (42 U.S.C. 1437f note) 

require HUD to establish guidelines for 

the development of OCAFs for rent 


asabaliauskas on DSKBBXCHB2PROD with NOTICES