49034 Federal Register / Vol. 82, No. 203 / Monday, October 23, 2017 / Notices 

identified, as confidential, if submitted 

as detailed in ‘‘Instructions.’’ 

Instructions: All submissions received 

must include the Docket No. FDA– 

2007–D–0369 for ‘‘Draft Guidance on 

Methylphenidate Hydrochloride.’’ 

Received comments will be placed in 

the docket and, except for those 

submitted as ‘‘Confidential 

Submissions,’’ publicly viewable at 

https://www.regulations.gov or at the 

Dockets Management Staff between 9 

a.m. and 4 p.m., Monday through 

Friday. 

• Confidential Submissions—To 

submit a comment with confidential 

information that you do not wish to be 

made publicly available, submit your 

comments only as a written/paper 

submission. You should submit two 

copies total. One copy will include the 

information you claim to be confidential 

with a heading or cover note that states 

‘‘THIS DOCUMENT CONTAINS 

CONFIDENTIAL INFORMATION.’’ The 

Agency will review this copy, including 

the claimed confidential information, in 

its consideration of comments. The 

second copy, which will have the 

claimed confidential information 

redacted/blacked out, will be available 

for public viewing and posted on 

https://www.regulations.gov. Submit 

both copies to the Dockets Management 

Staff. If you do not wish your name and 

contact information to be made publicly 

available, you can provide this 

information on the cover sheet and not 

in the body of your comments and you 

must identify this information as 

‘‘confidential.’’ Any information marked 

as ‘‘confidential’’ will not be disclosed 

except in accordance with 21 CFR 10.20 

and other applicable disclosure law. For 

more information about FDA’s posting 

of comments to public dockets, see 80 

FR 56469, September 18, 2015, or access 

the information at: https://www.gpo.gov/ 

fdsys/pkg/FR-2015-09-18/pdf/2015- 

23389.pdf. 

Docket: For access to the docket to 

read background documents or the 

electronic and written/paper comments 

received, go to https://

www.regulations.gov and insert the 

docket number, found in brackets in the 

heading of this document, into the 

‘‘Search’’ box and follow the prompts 

and/or go to the Dockets Management 

Staff, 5630 Fishers Lane, Rm. 1061, 

Rockville, MD 20852. 

You may submit comments on any 

guidance at any time (see 21 CFR 

10.115(g)(5)). 

Submit written requests for single 

copies of the draft guidance to the 

Division of Drug Information, Center for 

Drug Evaluation and Research, Food 

and Drug Administration, 10001 New 

Hampshire Ave., Hillandale Building, 

4th Floor, Silver Spring, MD 20993– 

0002. Send one self-addressed adhesive 

label to assist that office in processing 

your requests. See the SUPPLEMENTARY

INFORMATION section for electronic 

access to the draft guidance document. 

FOR FURTHER INFORMATION CONTACT: 

Xiaoqiu Tang, Center for Drug 

Evaluation and Research (HFD–600), 

Food and Drug Administration, 10903 

New Hampshire Ave., Bldg. 75, Rm. 

4730, Silver Spring, MD 20993–0002, 

301–796–5850. 

SUPPLEMENTARY INFORMATION: 

I. Background 

In the Federal Register of June 11, 

2010 (75 FR 33311), FDA announced the 

availability of a guidance for industry 

entitled ‘‘Bioequivalence 

Recommendations for Specific 

Products,’’ which explained the process 

that would be used to make productspecific guidances available to the 

public on FDA’s Web site at https://

www.fda.gov/Drugs/ 

GuidanceCompliance

RegulatoryInformation/Guidances/ 

default.htm. 

As described in that guidance, FDA 

adopted this process to develop and 

disseminate product-specific guidances 

and to provide a meaningful 

opportunity for the public to consider 

and comment on the guidances. This 

notice announces the availability of a 

new draft guidance for generic 

methylphenidate hydrochloride oral 

extended-release tablets. 

FDA initially approved new drug 

application 018029 for RITALIN–SR 

(methylphenidate hydrochloride oral 

extended-release tablets) in March 1982. 

We are now issuing a new draft 

guidance for industry on 

methylphenidate hydrochloride oral 

extended-release tablets (‘‘Draft 

Guidance on Methylphenidate 

Hydrochloride’’). 

In May 2016, KVK-Tech, Inc. (KVKTech) submitted a citizen petition 

requesting, among other things, that 

FDA not accept for filing any new 

ANDAs or approve any already received 

ANDAs for methylphenidate 

hydrochloride oral extended-release 

tablets unless certain BE criteria are 

met. FDA will consider any comments 

on the draft guidance on BE 

recommendations for generic 

methylphenidate hydrochloride oral 

extended-release tablets before 

responding to KVK-Tech’s citizen 

petition. (Docket No. FDA–2016–P– 

1247, available at https://

www.regulations.gov). 

The new draft guidance is being 

issued consistent with FDA’s good 

guidance practices regulation (21 CFR 

10.115). The new draft guidance, when 

finalized, will represent the current 

thinking of FDA on the design of BE 

studies to support ANDAs for 

methylphenidate hydrochloride oral 

extended-release tablets. 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. 

II. Electronic Access 

Persons with access to the internet 

may obtain the draft guidance at either 

https://www.fda.gov/Drugs/ 

GuidanceCompliance

RegulatoryInformation/Guidances/ 

default.htm or https://

www.regulations.gov. 

Dated: October 17, 2017. 

Anna K. Abram, 

Deputy Commissioner for Policy, Planning, 

Legislation, and Analysis. 

[FR Doc. 2017–22891 Filed 10–20–17; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Performance Review Board Members 

Title 5, U.S.C. Section 4314(c)(4) of 

the Civil Service Reform Act of 1978, 

Public Law 95–454, requires that the 

appointment of Performance Review 

Board Members be published in the 

Federal Register. The following persons 

may be named to serve on the 

Performance Review Boards or Panels, 

which oversee the evaluation of 

performance appraisals of Senior 

Executive Service members of the 

Department of Health and Human 

Services. 

Employee Name 

Barry, Daniel 

Barlow, Amanda 

Coughlin, Janis 

Fantinato, Jessica 

Gentile, John 

Johnson, Jeffrey 

Katz, Ruth 

Kretschmaier, Michon 

Lewis, Lisa 

McDaniel, Eileen 

Novy, Steve 

Sample, Allen 

Skeadas, Christos 

Tobias, Constance 

Weber, Mark 


ethrower on DSK3G9T082PROD with NOTICES
Federal Register / Vol. 82, No. 203 / Monday, October 23, 2017 / Notices 49035 

Dated: October 16, 2017. 

Charles H. McEnerney III, 

Director, Executive and Scientific Resources 

Division. 

[FR Doc. 2017–22863 Filed 10–20–17; 8:45 am] 

BILLING CODE 4151–17–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Indian Health Service 

Division of Behavioral Health; Youth 

Regional Treatment Center Aftercare 

Pilot Project; Correction of Due Dates 

AGENCY: Indian Health Service, HHS. 

ACTION: Notice; correction of due dates. 

SUMMARY: The Indian Health Service 

published a notice in the Federal 

Register (FR) on October 11, 2017, for 

the Fiscal Year 2018 Youth Regional 

Treatment Center Aftercare Pilot Project, 

Funding Announcement Number: HHS– 

2018–IHS–YRTC–0001. Several Key 

Dates have been modified. The 

Application Due Date is November 12, 

2017 and the Earliest Anticipated Start 

Date is December 1, 2017. 

FOR FURTHER INFORMATION CONTACT: Paul 

Gettys, Grant Systems Coordinator, 5600 

Fishers Lane, Mail Stop: 09E70, 

Rockville, MD 20857, Phone: (301) 443– 

2114; or the Division of Grants 

Management main line (301) 443–5204, 

or Fax: (301) 594–0899. 

Correction 

In the FR notice of October 11, 2017 

(FR 2017–21786), the corrections are: 

Key Dates 

Under the heading Key Dates, the 

notice should include the dates for 

Review Date, Signed Tribal Resolutions 

Due Date, and Proof of Non-Profit 

Status Due Date should read as: 

• Review Date: November 20–24, 

2017. 

• Signed Tribal Resolutions Due Date: 

November 12, 2017. 

• Proof of Non-Profit Status Due Date: 

November 12, 2017. 

The Application Due Date remains as 

November 12, 2017. 

Project Period 

Under Project Period, the sentence 

corrections reflects a start date of 

December 1, 2017: 

• ‘‘The project period is for three 

years and will run consecutively from 

December 1, 2017 to October 31, 2020.’’ 

Submission Dates 

Under Submission Dates and time: 

‘‘Eastern Daylight Time (EDT)’’ should 

be used instead of ‘‘Eastern Savings 

Time (EST).’’ 

Dated: October 13, 2017. 

Michael D. Weahkee, 

Assistant Surgeon General, U.S. Public Health 

Service, Acting Director, Indian Health 

Service. 

[FR Doc. 2017–22864 Filed 10–20–17; 8:45 am] 

BILLING CODE 4165–16–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute of Nursing Research; 

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 

Nursing Research Special Emphasis Panel; 

Palliative Care Research Cooperative. 

Date: November 3, 2017. 

Time: 8:00 a.m. to 1:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: Bethesda Marriott Suites, 6711 

Democracy Boulevard, Bethesda, MD 20817 

(Telephone Conference Call). 

Contact Person: Mario Rinaudo, MD, 

Scientific Review Officer, Office of Review, 

National Inst of Nursing Research, National 

Institutes of Health, 6701 Democracy Blvd. 

(DEM 1), Suite 710, Bethesda, MD 20892, 

301–594–5973, mrinaudo@mail.nih.gov. 

Name of Committee: National Institute of 

Nursing Research Special Emphasis Panel; 

Lasker Clinical Research Scholars Program. 

Date: November 7, 2017. 

Time: 11:00 a.m. to 1:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 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 Blvd., 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 18, 2017. 

Sylvia L. Neal, 

Program Analyst, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2017–22911 Filed 10–20–17; 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 Meeting 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended, notice is hereby given of a 

meeting of the NHLBI Special Emphasis 

Panel. 

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 Heart, Lung, 

and Blood Institute Special Emphasis Panel; 

SPIROMICS Genomics and Informatics 

Center (U24). 

Date: November 15, 2017. 

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

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 6701 

Rockledge Drive, Suite 7182, Bethesda, MD 

20892 (Telephone Conference Call). 

Contact Person: Susan Wohler Sunnarborg, 

Ph.D., Scientific Review Officer, Office of 

Scientific Review/DERA, National, Heart, 

Lung, and Blood Institute, 6701 Rockledge 

Drive, Room 7182, Bethesda, MD 20892, 

susan.sunnarborg@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 17, 2017. 

Michelle Trout, 

Program Analyst, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2017–22908 Filed 10–20–17; 8:45 am] 

BILLING CODE 4140–01–P 


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