Federal Register / Vol. 82, No. 171 / Wednesday, September 6, 2017 / Notices 42103 

provides recommendations for the 

content of premarket submissions and 

labeling for such devices. 

In the Federal Register of January 26, 

2016 (81 FR 4303), FDA announced the 

availability of the draft of this guidance 

and interested persons were invited to 

comment by March 28, 2016. The 

comment period was extended on 

February 23, 2016 (81 FR 8966), to April 

28, 2016. FDA has considered all of the 

public comments received in finalizing 

this guidance. 

FDA recognizes and anticipates that 

the Agency and industry may need up 

to 60 days to perform activities to 

operationalize the policies within the 

guidance. If new information regarding 

device interoperability as outlined in 

this guidance is not included in a 

premarket submission received by FDA 

before or up to 60 days after the 

publication of this guidance, CDRH staff 

does not generally intend to request 

such information during the review of 

the submission. CDRH does, however, 

intend to review any such information 

if submitted. 

II. Significance of Guidance 

This guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The guidance represents the current 

thinking of FDA on ‘‘Design 

Considerations and Premarket 

Submission Recommendations for 

Interoperable Medical Devices.’’ It does 

not establish any rights for any person 

and is not binding on FDA or the public. 

You can use an alternative approach if 

it satisfies the requirements of the 

applicable statutes and regulations. This 

guidance is not subject to Executive 

Order 12866. 

III. Paperwork Reduction Act of 1995 

This guidance refers to previously 

approved collections of information 

found in FDA regulations. These 

collections of information are subject to 

review by the Office of Management and 

Budget (OMB) under the Paperwork 

Reduction Act of 1995 (44 U.S.C. 3501– 

3520). The collections of information in 

21 CFR part 820 have been approved 

under OMB control number 0910–0073; 

the collections of information in 21 CFR 

part 812 have been approved under 

OMB control number 0910–0078; the 

collections of information in 21 CFR 

part 807, subpart E, have been approved 

under OMB control number 0910–0120; 

the collections of information in 21 CFR 

part 814, subparts A through E, have 

been approved under OMB control 

number 0910–0231; the collections of 

information in 21 CFR part 814, subpart 

H have been approved under OMB 

control number 0910–0332; the 

collections of information in 21 CFR 

part 601 have been approved under 

OMB control number 0910–0338; the 

collections of information in 21 CFR 

parts 801 and 809 have been approved 

under OMB control number 0910–0485; 

and the collections of information in 21 

CFR parts 610 and 660 have been 

approved under OMB control number 

0910–0338. 

IV. Electronic Access 

Persons interested in obtaining a copy 

of the guidance may do so by 

downloading an electronic copy from 

the Internet. A search capability for all 

Center for Devices and Radiological 

Health guidance documents is available 

at https://www.fda.gov/MedicalDevices/

DeviceRegulationandGuidance/

GuidanceDocuments/default.htm. 

Guidance documents are also available 

at https://www.fda.gov/BiologicsBlood

Vaccines/GuidanceCompliance

RegulatoryInformation/default.htm or 

https://www.regulations.gov. Persons 

unable to download an electronic copy 

of ‘‘Design Considerations and 

Premarket Submission 

Recommendations for Interoperable 

Medical Devices’’ may send an email 

request to CDRH-Guidance@fda.hhs.gov 

to receive an electronic copy of the 

document. Please use the document 

number 1500015 to identify the 

guidance you are requesting. 

Dated: August 30, 2017. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2017–18815 Filed 9–5–17; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2017–P–2496] 

Determination That RITALIN LA 

(Methylphenidate Hydrochloride) 

Extended-Release Capsules, 60 

Milligrams, Were Not Withdrawn From 

Sale for Reasons of Safety or 

Effectiveness 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) has 

determined that RITALIN LA 

(methylphenidate hydrochloride) 

extended-release capsules, 60 

milligrams (mg), were not withdrawn 

from sale for reasons of safety or 

effectiveness. This determination will 

allow FDA to approve abbreviated new 

drug applications (ANDAs) for 

methylphenidate hydrochloride 

extended-release capsules, 60 mg, if all 

other legal and regulatory requirements 

are met. 

FOR FURTHER INFORMATION CONTACT: 

Christopher Koepke, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 51, Rm. 6224, 

Silver Spring, MD 20993–0002, 240– 

402–3543. 

SUPPLEMENTARY INFORMATION: In 1984, 

Congress enacted the Drug Price 

Competition and Patent Term 

Restoration Act of 1984 (Pub. L. 98–417) 

(the 1984 amendments), which 

authorized the approval of duplicate 

versions of drug products under an 

ANDA procedure. ANDA applicants 

must, with certain exceptions, show that 

the drug for which they are seeking 

approval contains the same active 

ingredient in the same strength and 

dosage form as the ‘‘listed drug,’’ which 

is a version of the drug that was 

previously approved. ANDA applicants 

do not have to repeat the extensive 

clinical testing otherwise necessary to 

gain approval of a new drug application 

(NDA). 

The 1984 amendments include what 

is now section 505(j)(7) of the Federal 

Food, Drug, and Cosmetic Act (21 U.S.C. 

355(j)(7)), which requires FDA to 

publish a list of all approved drugs. 

FDA publishes this list as part of the 

‘‘Approved Drug Products With 

Therapeutic Equivalence Evaluations,’’ 

which is known generally as the 

‘‘Orange Book.’’ Under FDA regulations, 

drugs are removed from the list if the 

Agency withdraws or suspends 

approval of the drug’s NDA or ANDA 

for reasons of safety or effectiveness or 

if FDA determines that the listed drug 

was withdrawn from sale for reasons of 

safety or effectiveness (21 CFR 314.162). 

A person may petition the Agency to 

determine, or the Agency may 

determine on its own initiative, whether 

a listed drug was withdrawn from sale 

for reasons of safety or effectiveness. 

This determination may be made at any 

time after the drug has been withdrawn 

from sale, but must be made prior to 

approving an ANDA that refers to the 

listed drug (21 CFR 314.161). FDA may 

not approve an ANDA that does not 

refer to a listed drug. 

RITALIN LA (methylphenidate 

hydrochloride) extended-release 

capsules, 60 mg, are the subject of NDA 

021284, held by Novartis 

Pharmaceuticals Corp. (Novartis) and 

initially approved on October 27, 2014. 

RITALIN LA is indicated for the 


asabaliauskas on DSKBBXCHB2PROD with NOTICES
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 


asabaliauskas on DSKBBXCHB2PROD with NOTICES