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

treatment of Attention Deficit 

Hyperactivity Disorder (ADHD). 

In a letter dated March 23, 2016, 

Novartis notified FDA that RITALIN LA 

(methylphenidate hydrochloride) 

extended-release capsules, 60 mg, were 

being discontinued, and FDA moved the 

drug product to the ‘‘Discontinued Drug 

Product List’’ section of the Orange 

Book. 

Abhai, LLC, submitted a citizen 

petition dated April 19, 2017 (Docket 

No. FDA–2017–P–2496), under 21 CFR 

10.30, requesting that the Agency 

determine whether RITALIN LA 

(methylphenidate hydrochloride) 

extended-release capsules, 60 mg, were 

withdrawn from sale for reasons of 

safety or effectiveness. 

After considering the citizen petition 

and reviewing Agency records, and 

based on the information we have at this 

time, FDA has determined under 

§ 314.161 that RITALIN LA 

(methylphenidate hydrochloride) 

extended-release capsules, 60 mg, were 

not withdrawn for reasons of safety or 

effectiveness. The petitioner has 

identified no data or other information 

suggesting that RITALIN LA 

(methylphenidate hydrochloride) 

extended-release capsules, 60 mg, were 

withdrawn for reasons of safety or 

effectiveness. We have carefully 

reviewed our files for records 

concerning the withdrawal of RITALIN 

LA (methylphenidate hydrochloride) 

extended-release capsules, 60 mg, from 

sale. We have also independently 

evaluated relevant literature and data 

for possible postmarketing adverse 

events. We have reviewed the available 

evidence and determined that this drug 

product was not withdrawn from sale 

for reasons of safety or effectiveness. 

Accordingly, the Agency will 

continue to list RITALIN LA 

(methylphenidate hydrochloride) 

extended-release capsules, 60 mg, in the 

‘‘Discontinued Drug Product List’’ 

section of the Orange Book. The 

‘‘Discontinued Drug Product List’’ 

delineates, among other items, drug 

products that have been discontinued 

from marketing for reasons other than 

safety or effectiveness. ANDAs that refer 

to RITALIN LA (methylphenidate 

hydrochloride) extended-release 

capsules, 60 mg, may be approved by 

the Agency as long as they meet all 

other legal and regulatory requirements 

for the approval of ANDAs. If FDA 

determines that labeling for this drug 

product should be revised to meet 

current standards, the Agency will 

advise ANDA applicants to submit such 

labeling. 

Dated: August 28, 2017. 

Anna K. Abram, 

Deputy Commissioner for Policy, Planning, 

Legislation, and Analysis. 

[FR Doc. 2017–18817 Filed 9–5–17; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute on Aging; 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 on 

Aging Initial Review Group; Clinical Aging 

Review Committee. 

Date: October 5–6, 2017. 

Time: 3:30 p.m. to 1:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: Bethesda Marriott, 5151 Pooks Hill 

Road, Bethesda, MD 20814. 

Contact Person: Alicja L. Markowska, 

Ph.D., DSC, National Institute on Aging, 

National Institutes of Health, Gateway 

Building 2C212, 7201 Wisconsin Avenue, 

Bethesda, MD 20892, 301–496–9666, 

markowsa@nia.nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.866, Aging Research, 

National Institutes of Health, HHS) 

Dated: August 30, 2017. 

Melanie J. Pantoja, 

Program Analyst, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2017–18805 Filed 9–5–17; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Cancer Institute Amended 

Notice of Meeting 

Notice is hereby given of a change in 

the meeting of the National Cancer 

Advisory Board, September 12, 2017, 

1:00 p.m. to September 12, 2017, 4:00 

p.m., National Cancer Institute—Shady 

Grove, 9609 Medical Center Drive, 

Conference Room TE406 and TE408, 

Rockville, MD, 20850 (Virtual Meeting) 

which was published in the Federal 

Register on August 14, 2017, 82 FR 

37885. 

The meeting notice is amended to 

change the times of the open and closed 

sessions. The open session will end at 

2:15 p.m. The closed session will begin 

at 2:30 p.m. and end at 3:30 p.m. The 

meeting is partially closed to the public. 

Dated: August 30, 2017. 

Melanie J. Pantoja, 

Program Analyst Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2017–18804 Filed 9–5–17; 8:45 am] 

BILLING CODE 4140–01–P 

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, 

begumn@niddk.nih.gov. 

Name of Committee: National Institute of 

Diabetes and Digestive and Kidney Diseases 

Special Emphasis Panel, PAR–16–126: High 

Impact, Interdisciplinary Science in NIDDK 


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