Federal Register / Vol. 79, No. 215 / Thursday, November 6, 2014 / Notices 65979 

SUPPLEMENTARY INFORMATION: 

I. Background 

In the Federal Register of June 11, 

2010 (75 FR 33311), FDA announced the 

availability of a guidance for industry, 

‘‘Bioequivalence Recommendations for 

Specific Products,’’ which explained the 

process that would be used to make 

product-specific BE recommendations 

available to the public on FDA’s Web 

site at http://www.fda.gov/Drugs/ 

GuidanceCompliance

RegulatoryInformation/Guidances/

default.htm. As described in that 

guidance, FDA adopted this process as 

a means to develop and disseminate 

product-specific BE recommendations 

and provide a meaningful opportunity 

for the public to consider and comment 

on those recommendations. This notice 

announces the availability of draft BE 

recommendations for CONCERTA 

(methylphenidate HCl) extended-release 

tablets. This draft guidance revises and 

replaces the draft guidance for industry 

entitled ‘‘Draft and Revised Draft 

Guidances for Industry Describing 

Product-Specific Bioequivalence 

Recommendations; Availability,’’ issued 

on September 14, 2012 (77 FR 56851), 

which provided recommendations to 

establish BE to CONCERTA 

(methylphenidate hydrochloride) (NDA 

021121). 

This draft guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The draft guidance, when finalized, will 

represent the Agency’s current thinking 

on the design of BE studies to support 

ANDAs for CONCERTA 

(methylphenidate HCl) extended-release 

tablets. It does not create or confer any 

rights for or on any person and does not 

operate to bind FDA or the public. An 

alternative approach may be used if 

such approach satisfies the 

requirements of the applicable statutes 

and regulations. 

II. Comments 

Interested persons may submit either 

electronic comments regarding this 

document to http://www.regulations.gov 

or written comments to the Division of 

Dockets Management (see ADDRESSES). It 

is only necessary to send one set of 

comments. Identify comments with the 

docket number found in brackets in the 

heading of this document. Received 

comments may be seen in the Division 

of Dockets Management between 9 a.m. 

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

will be posted to the docket at http://

www.regulations.gov. 

III. Electronic Access 

Persons with access to the Internet 

may obtain the document at either 

http://www.fda.gov/Drugs/Guidance

ComplianceRegulatoryInformation/

Guidances/default.htm or http://

www.regulations.gov. 

Dated: October 31, 2014. 

Leslie Kux, 

Assistant Commissioner for Policy. 

[FR Doc. 2014–26306 Filed 11–5–14; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Office of the Director, Program on 

Biosecurity and Biosafety Policy; 

Notice of Meeting 

Pursuant to section 10(a) of the 

Federal Advisory Committee Act, as 

amended (5 U.S.C. App.), notice is 

hereby given of the meeting of the 

National Science Advisory Board for 

Biosecurity (NSABB). 

Name of Committee: National Science 

Advisory Board for Biosecurity. 

Date: November 25, 2014. 

Time: 11:00 a.m.–1:00 p.m. Eastern. 

The teleconference line will be open at 

10:30 a.m. to allow for check-in with the 

operator. (Times are approximate and 

subject to change.) 

Agenda: Discussion regarding: (1) 

Finalization of draft NSABB statement 

regarding gain-of-function research; and 

(2) other business of the Board. Time 

will be allotted on the agenda for oral 

public comment, with presentations 

limited to three minutes per speaker. 

Place: National Institutes of Health, 

6705 Rockledge Drive, Suite 750, 

Bethesda, Maryland. (Telephone 

Conference call only; No in-person 

meeting.) 

Call-in Information: Toll-Free 

Number: 1–888–469–1981. Participant 

Passcode: NSABB. The line will be open 

30 minutes in advance of the meeting to 

allow time for operator-assisted checkin. 

Contact Person: Carolyn Mosby, 

NSABB Program Assistant, NIH Program 

on Biosecurity and Biosafety Policy, 

6705 Rockledge Drive, Suite 750, 

Bethesda, Maryland 20892, (301) 435– 

5504, carolyn.mosby@nih.gov. 

Under authority 42 U.S.C. 217a, 

Section 222 of the Public Health Service 

Act, as amended, the Department of 

Health and Human Services established 

the NSABB to provide advice regarding 

federal oversight of dual use research, 

defined as biological research that 

generates information and technologies 

that could be misused to pose a 

biological threat to public health and/or 

national security. 

Please Note: The teleconference 

meeting agenda, draft statement, and 

other information about the NSABB will 

be available at http://osp.od.nih.gov/

office-biotechnology-activities/

biosecurity/nsabb. Please check this 

Web site for updates. 

The meeting will be open to the 

public through a teleconference call 

phone number. Members of the public 

who participate in the teleconference 

will be able to listen to the meeting but 

will not be heard apart from during the 

public comment session. If you 

experience any technical problems with 

the conference call, please send an 

email to carolyn.mosby@nih.gov. 

Public Comments: The teleconference 

will include opportunity for public 

comment. In addition, any interested 

person may file written comments with 

the committee via email to nsabb@

od.nih.gov with ‘‘NSABB Public 

Comment’’ as the subject line or by 

regular mail to 6705 Rockledge Drive, 

Suite 750, Bethesda, MD 20892, 

Attention: Carolyn Mosby. Comments 

should include the name, address, 

telephone number and, when 

applicable, the business or professional 

affiliation of the commenter. Written 

comments received by 5:00 p.m. 

(Eastern) on Sunday November 23, 

2014, will be provided to NSABB 

members prior to the teleconference. 

Accommodations Statement: 

Individuals who participate by using 

this teleconference call service and who 

need special assistance such as 

captioning or other reasonable 

accommodations should submit a 

request to the Contact Person listed on 

this notice as soon as possible. 

Dated: November 3, 2014. 

David Clary, 

Program Analyst, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2014–26422 Filed 11–5–14; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HOMELAND 

SECURITY 

U.S. Citizenship and Immigration 

Services 

[OMB Control Number 1615–0025] 

Agency Information Collection 

Activities: Waiver of Rights, Privileges, 

Exemptions and Immunities, Forms I– 

508 and I–508F; Revision of a Currently 

Approved Collection. 

ACTION: 60-day notice. 

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