82 FR 42104 - National Institute of Diabetes and Digestive and Kidney Diseases; Notice of Closed Meetings

DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health

Federal Register Volume 82, Issue 171 (September 6, 2017)

Page Range		42104-42105
FR Document		2017-18806

Federal Register, Volume 82 Issue 171 (Wednesday, September 6, 2017)

[Federal Register Volume 82, Number 171 (Wednesday, September 6, 2017)]
[Notices]
[Pages 42104-42105]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-18806]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


National Institute of Diabetes and Digestive and Kidney Diseases; 
Notice of Closed Meetings

    Pursuant to section 10(d) of the Federal Advisory Committee Act, as 
amended, notice is hereby given of the following 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 Institute of Diabetes and Digestive 
and Kidney Diseases Special Emphasis Panel; PAR-15-067: NIDDK Multi-
Center Clinical Study Cooperative Agreement (U01): CKD and Bone 
Mineral Disorders in Children.
    Date: October 2, 2017.
    Time: 11:00 a.m. to 2:00 p.m.
    Agenda: To review and evaluate cooperative agreement 
applications.
    Place: National Institutes of Health, Two Democracy Plaza, 6707 
Democracy Boulevard, Bethesda, MD 20892 (Telephone Conference Call).
    Contact Person: Najma S. Begum, Ph.D., Scientific Review 
Officer, Review Branch, DEA, NIDDK, National Institutes of Health, 
Room 7349, 6707 Democracy Boulevard, Bethesda, MD 20892-5452, (301) 
594-8894, [email protected].

    Name of Committee: National Institute of Diabetes and Digestive 
and Kidney Diseases Special Emphasis Panel, PAR-16-126: High Impact, 
Interdisciplinary Science in NIDDK

[[Page 42105]]

Research Areas (RC2)--Diabetes, Endocrinology and Metabolic 
Diseases.
    Date: October 10, 2017.
    Time: 3:00 p.m. to 4:30 p.m.
    Agenda: To review and evaluate grant applications.
    Place: National Institutes of Health, Two Democracy Plaza, 6707 
Democracy Boulevard, Bethesda, MD 20892 (Telephone Conference Call).
    Contact Person: Dianne Camp, Ph.D., Scientific Review Officer, 
Review Branch, DEA, NIDDK, National Institutes of Health, Room 7013, 
6707 Democracy Boulevard, Bethesda, MD 20892-2542, 301-594-7682, 
[email protected].

    Name of Committee: National Institute of Diabetes and Digestive 
and Kidney Diseases Special Emphasis Panel; PAR-16-034: Ancillary 
Studies on Diabetes.
    Date: October 12, 2017.
    Time: 1:00 p.m. to 2:00 p.m.
    Agenda: To review and evaluate grant applications.
    Place: National Institutes of Health, Two Democracy Plaza, 6707 
Democracy Boulevard, Bethesda, MD 20892 (Telephone Conference Call).
    Contact Person: Dianne Camp, Ph.D., Scientific Review Officer, 
Review Branch, DEA, NIDDK, National Institutes of Health, Room 7013, 
6707 Democracy Boulevard, Bethesda, MD 20892-2542, 301-594-7682, 
[email protected].

    Name of Committee: National Institute of Diabetes and Digestive 
and Kidney Diseases Special Emphasis Panel; DDK-B Conflict.
    Date: October 18, 2017.
    Time: 10:00 a.m. to 12:00 p.m.
    Agenda: To review and evaluate grant applications.
    Place: Doubletree Hotel Bethesda, (Formerly Holiday Inn Select), 
8120 Wisconsin Avenue, Bethesda, MD 20814.
    Contact Person: Thomas A. Tatham, Ph.D., Scientific Review 
Officer, Review Branch, DEA, NIDDK, National Institutes of Health, 
Room 7021, 6707 Democracy Boulevard, Bethesda, MD 20892-5452, (301) 
594-3993, [email protected]

(Catalogue of Federal Domestic Assistance Program Nos. 93.847, 
Diabetes, Endocrinology and Metabolic Research; 93.848, Digestive 
Diseases and Nutrition Research; 93.849, Kidney Diseases, Urology 
and Hematology Research, National Institutes of Health, HHS)

    Dated: August 30, 2017.
David Clary,
Program Analyst, Office of Federal Advisory Committee Policy.
[FR Doc. 2017-18806 Filed 9-5-17; 8:45 am]
 BILLING CODE 4140-01-P

42104 Federal Register / Vol. 82, No. 171 / Wednesday, September 6, 2017 / Notices

treatment of Attention Deficit Dated: August 28, 2017. p.m., National Cancer Institute—Shady
Hyperactivity Disorder (ADHD). Anna K. Abram, Grove, 9609 Medical Center Drive,
In a letter dated March 23, 2016, Deputy Commissioner for Policy, Planning, Conference Room TE406 and TE408,
Novartis notified FDA that RITALIN LA Legislation, and Analysis. Rockville, MD, 20850 (Virtual Meeting)
(methylphenidate hydrochloride) [FR Doc. 2017–18817 Filed 9–5–17; 8:45 am] which was published in the Federal
extended-release capsules, 60 mg, were BILLING CODE 4164–01–P Register on August 14, 2017, 82 FR
being discontinued, and FDA moved the 37885.
drug product to the ‘‘Discontinued Drug The meeting notice is amended to
Product List’’ section of the Orange DEPARTMENT OF HEALTH AND change the times of the open and closed
Book. HUMAN SERVICES sessions. The open session will end at
2:15 p.m. The closed session will begin
Abhai, LLC, submitted a citizen National Institutes of Health at 2:30 p.m. and end at 3:30 p.m. The
petition dated April 19, 2017 (Docket meeting is partially closed to the public.
No. FDA–2017–P–2496), under 21 CFR National Institute on Aging; Notice of
10.30, requesting that the Agency Closed Meeting Dated: August 30, 2017.
determine whether RITALIN LA Melanie J. Pantoja,
Pursuant to section 10(d) of the Program Analyst Office of Federal Advisory
(methylphenidate hydrochloride)
Federal Advisory Committee Act, as Committee Policy.
extended-release capsules, 60 mg, were
amended, notice is hereby given of the [FR Doc. 2017–18804 Filed 9–5–17; 8:45 am]
withdrawn from sale for reasons of
following meeting.
safety or effectiveness. The meeting will be closed to the
BILLING CODE 4140–01–P

After considering the citizen petition public in accordance with the
and reviewing Agency records, and provisions set forth in sections DEPARTMENT OF HEALTH AND
based on the information we have at this 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., HUMAN SERVICES
time, FDA has determined under as amended. The grant applications and
§ 314.161 that RITALIN LA the discussions could disclose National Institutes of Health
(methylphenidate hydrochloride) confidential trade secrets or commercial
extended-release capsules, 60 mg, were property such as patentable material, National Institute of Diabetes and
not withdrawn for reasons of safety or and personal information concerning Digestive and Kidney Diseases; Notice
effectiveness. The petitioner has individuals associated with the grant of Closed Meetings
identified no data or other information applications, the disclosure of which Pursuant to section 10(d) of the
suggesting that RITALIN LA would constitute a clearly unwarranted Federal Advisory Committee Act, as
(methylphenidate hydrochloride) invasion of personal privacy. amended, notice is hereby given of the
extended-release capsules, 60 mg, were Name of Committee: National Institute on following meetings.
withdrawn for reasons of safety or Aging Initial Review Group; Clinical Aging The meetings will be closed to the
effectiveness. We have carefully Review Committee. public in accordance with the
reviewed our files for records Date: October 5–6, 2017. provisions set forth in sections
concerning the withdrawal of RITALIN Time: 3:30 p.m. to 1:00 p.m. 552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
LA (methylphenidate hydrochloride) Agenda: To review and evaluate grant
applications. as amended. The grant applications and
extended-release capsules, 60 mg, from the discussions could disclose
sale. We have also independently Place: Bethesda Marriott, 5151 Pooks Hill
Road, Bethesda, MD 20814. confidential trade secrets or commercial
evaluated relevant literature and data Contact Person: Alicja L. Markowska, property such as patentable material,
for possible postmarketing adverse Ph.D., DSC, National Institute on Aging, and personal information concerning
events. We have reviewed the available National Institutes of Health, Gateway individuals associated with the grant
evidence and determined that this drug Building 2C212, 7201 Wisconsin Avenue, applications, the disclosure of which
product was not withdrawn from sale Bethesda, MD 20892, 301–496–9666, would constitute a clearly unwarranted
for reasons of safety or effectiveness. markowsa@nia.nih.gov.
invasion of personal privacy.
Accordingly, the Agency will (Catalogue of Federal Domestic Assistance
Program Nos. 93.866, Aging Research, Name of Committee: National Institute of
continue to list RITALIN LA National Institutes of Health, HHS) Diabetes and Digestive and Kidney Diseases
(methylphenidate hydrochloride) Special Emphasis Panel; PAR–15–067:
extended-release capsules, 60 mg, in the Dated: August 30, 2017. NIDDK Multi-Center Clinical Study
‘‘Discontinued Drug Product List’’ Melanie J. Pantoja, Cooperative Agreement (U01): CKD and Bone
section of the Orange Book. The Program Analyst, Office of Federal Advisory Mineral Disorders in Children.
‘‘Discontinued Drug Product List’’ Committee Policy. Date: October 2, 2017.
Time: 11:00 a.m. to 2:00 p.m.
delineates, among other items, drug [FR Doc. 2017–18805 Filed 9–5–17; 8:45 am]
Agenda: To review and evaluate
products that have been discontinued BILLING CODE 4140–01–P cooperative agreement applications.
from marketing for reasons other than Place: National Institutes of Health, Two
safety or effectiveness. ANDAs that refer Democracy Plaza, 6707 Democracy
to RITALIN LA (methylphenidate DEPARTMENT OF HEALTH AND Boulevard, Bethesda, MD 20892 (Telephone
hydrochloride) extended-release HUMAN SERVICES Conference Call).
Contact Person: Najma S. Begum, Ph.D.,
asabaliauskas on DSKBBXCHB2PROD with NOTICES

capsules, 60 mg, may be approved by
the Agency as long as they meet all National Institutes of Health Scientific Review Officer, Review Branch,
DEA, NIDDK, National Institutes of Health,
other legal and regulatory requirements
National Cancer Institute Amended Room 7349, 6707 Democracy Boulevard,
for the approval of ANDAs. If FDA Bethesda, MD 20892–5452, (301) 594–8894,
Notice of Meeting
determines that labeling for this drug begumn@niddk.nih.gov.
product should be revised to meet Notice is hereby given of a change in Name of Committee: National Institute of
current standards, the Agency will the meeting of the National Cancer Diabetes and Digestive and Kidney Diseases
advise ANDA applicants to submit such Advisory Board, September 12, 2017, Special Emphasis Panel, PAR–16–126: High
labeling. 1:00 p.m. to September 12, 2017, 4:00 Impact, Interdisciplinary Science in NIDDK

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Federal Register / Vol. 82, No. 171 / Wednesday, September 6, 2017 / Notices 42105

Research Areas (RC2)—Diabetes, DEPARTMENT OF HOMELAND technological collection techniques or
Endocrinology and Metabolic Diseases. SECURITY other forms of information technology,
Date: October 10, 2017. e.g., permitting electronic submission of
Time: 3:00 p.m. to 4:30 p.m. U.S. Immigration and Customs responses.
Agenda: To review and evaluate grant Enforcement
applications. Overview of This Information
[OMB Control Number 1653–0022] Collection
Place: National Institutes of Health, Two
Democracy Plaza, 6707 Democracy Agency Information Collection (1) Type of Information Collection:
Boulevard, Bethesda, MD 20892 (Telephone Activities; Extension, Without Change, Extension, Without Change, of a
Conference Call). Currently Approved Collection.
of a Currently Approved Collection:
Contact Person: Dianne Camp, Ph.D., (2) Title of the Form/Collection:
Immigration Bond
Scientific Review Officer, Review Branch, Immigration Bond.
DEA, NIDDK, National Institutes of Health, AGENCY: U.S. Immigration and Customs (3) Agency form number, if any, and
Room 7013, 6707 Democracy Boulevard, Enforcement, Department of Homeland the applicable component of the
Bethesda, MD 20892–2542, 301–594–7682, Security. Department of Homeland Security
campd@extra.niddk.nih.gov. ACTION: 30-Day notice. sponsoring the collection: Form I–352;
Name of Committee: National Institute of USICE.
Diabetes and Digestive and Kidney Diseases The Department of Homeland (4) Affected public who will be asked
Special Emphasis Panel; PAR–16–034: Security (DHS), U.S. Immigration and or required to respond, as well as a brief
Ancillary Studies on Diabetes. Customs Enforcement (USICE) is abstract: Primary: Individual or
Date: October 12, 2017. submitting the following information Households, Business or other non-
Time: 1:00 p.m. to 2:00 p.m. collection request to the Office of profit. Form I–352 is used by USICE to
Agenda: To review and evaluate grant Management and Budget (OMB) for ensure the person or company posting
applications. review and clearance in accordance the bond is aware of the duties and
Place: National Institutes of Health, Two with the Paperwork Reduction Act of responsibilities associated with the
Democracy Plaza, 6707 Democracy 1995. The information collection notice bond. The collection instrument serves
Boulevard, Bethesda, MD 20892 (Telephone was previously published in the Federal the purpose of instruction in the
Conference Call). Register on June 26, 2017, Vol. 82 FR completion of the form, together with an
Contact Person: Dianne Camp, Ph.D., 28874, allowing for a 60-day public explanation of the terms and conditions
Scientific Review Officer, Review Branch, comment period. USICE did not receive of the bond. Sureties have the capability
DEA, NIDDK, National Institutes of Health, any comment in connection with the 60- of accessing, completing and submitting
Room 7013, 6707 Democracy Boulevard, day notice. The purpose of this notice a bond electronically through USICE’s
Bethesda, MD 20892–2542, 301–594–7682, is to allow an additional 30 days for eBonds system, while individuals are
campd@extra.niddk.nih.gov. public comments. required to complete the bond form
Name of Committee: National Institute of Written comments and/or suggestions manually.
Diabetes and Digestive and Kidney Diseases regarding the items contained in this (5) An estimate of the total number of
Special Emphasis Panel; DDK–B Conflict. notice, especially regarding the respondents and the amount of time
Date: October 18, 2017. estimated public burden and associated estimated for an average respondent to
Time: 10:00 a.m. to 12:00 p.m. response time, must be directed to the respond: 25,000 responses at 30 minutes
Agenda: To review and evaluate grant OMB Desk Officer for U.S. Immigration (.50 hours) per response.
applications. and Customs Enforcement, Department (6) An estimate of the total public
Place: Doubletree Hotel Bethesda, of Homeland Security and sent via burden (in hours) associated with the
(Formerly Holiday Inn Select), 8120 electronic mail to dhsdeskofficer@ collection: 12,500 annual burden hours.
Wisconsin Avenue, Bethesda, MD 20814. omb.eop.gov. All submissions received
Contact Person: Thomas A. Tatham, Ph.D., must include the agency name and the Dated: August 30, 2017.
Scientific Review Officer, Review Branch, OMB Control Number 1653–0022. Scott Elmore,
DEA, NIDDK, National Institutes of Health, Written comments and suggestions PRA Clearance Officer, Office of the Chief
Room 7021, 6707 Democracy Boulevard, from the public and affected agencies Information Officer, U.S. Immigration and
Bethesda, MD 20892–5452, (301) 594–3993, should address one or more of the Customs Enforcement, Department of
tathamt@mail.nih.gov following four points: Homeland Security.
(Catalogue of Federal Domestic Assistance (1) Evaluate whether the proposed [FR Doc. 2017–18809 Filed 9–5–17; 8:45 am]
Program Nos. 93.847, Diabetes, collection of information is necessary BILLING CODE 9111–28–P
Endocrinology and Metabolic Research; for the proper performance of the
93.848, Digestive Diseases and Nutrition functions of the agency, including
Research; 93.849, Kidney Diseases, Urology whether the information will have DEPARTMENT OF HOUSING AND
and Hematology Research, National Institutes practical utility; URBAN DEVELOPMENT
of Health, HHS) (2) Evaluate the accuracy of the
[Docket No. FR–5997–N–49]
agencies estimate of the burden of the
Dated: August 30, 2017.
proposed collection of information, 30-Day Notice of Proposed Information
David Clary, including the validity of the Collection: Public Housing Financial
asabaliauskas on DSKBBXCHB2PROD with NOTICES

Program Analyst, Office of Federal Advisory methodology and assumptions used;
Committee Policy. Management Template
(3) Enhance the quality, utility, and
[FR Doc. 2017–18806 Filed 9–5–17; 8:45 am] clarity of the information to be AGENCY: Office of the Chief Information
BILLING CODE 4140–01–P collected; and Officer, HUD.
(4) Minimize the burden of the ACTION: Notice.
collection of information on those who
are to respond, including through the SUMMARY: HUD submitted the proposed
use of appropriate automated, information collection requirement
electronic, mechanical, or other described below to the Office of

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Document Created: 2017-09-06 00:56:54
Document Modified: 2017-09-06 00:56:54

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 2, 2017.
FR Citation		82 FR 42104

82 FR 42104 - National Institute of Diabetes and Digestive and Kidney Diseases; Notice of Closed Meetings

DEPARTMENT OF HEALTH AND HUMAN SERVICESNational Institutes of Health

Federal Register Volume 82, Issue 171 (September 6, 2017)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health