65978 Federal Register / Vol. 79, No. 215 / Thursday, November 6, 2014 / Notices 

Division of Dockets Management (HFA– 

305), Food and Drug Administration, 

5630 Fishers Lane, Rm. 1061, Rockville, 

MD 20852. 

FOR FURTHER INFORMATION CONTACT: Paul 

Loebach, Center for Drug Evaluation and 

Research, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 51, Rm. 2262, Silver Spring, 

MD 20993–0002, edrls@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a guidance for industry entitled 

‘‘Specification of the Unique Facility 

Identifier (UFI) System for Drug 

Establishment Registration.’’ In July 

2012, FDASIA was signed into law (Pub. 

L. 112–144). Sections 701 and 702 of 

FDASIA direct the Secretary of Health 

and Human Services (and by delegation, 

FDA) to specify the UFI system for 

registration of domestic and foreign 

drug establishments. Once the UFI 

system is specified, section 510 of the 

FD&C Act (21 U.S.C. 360), as amended, 

requires that each initial and annual 

drug establishment registration include 

a UFI (21 U.S.C. 360(b), (c), and (i)). 

This guidance is intended solely to 

address sections 701 and 702 of 

FDASIA. Although section 703 of 

FDASIA mandates the use of the same 

UFI system (specified for drug 

establishment registration) to identify 

excipient manufacturers in product 

listings, this guidance does not address 

implementation of section 703 of 

FDASIA. 

This guidance specifies the UFI 

system for registration of domestic and 

foreign drug establishments. At this 

time, FDA’s preferred UFI for a drug 

establishment is the Data Universal 

Numbering System (DUNS) number, 

assigned and managed by Dun and 

Bradstreet. The DUNS number is 

available free of charge to all drug 

establishments and may be obtained by 

visiting Dun and Bradstreet’s Web site at 

http://www.dnb.com/. (FDA has verified 

the Web site address, but FDA is not 

responsible for any subsequent changes 

to the Web site after this document 

publishes in the Federal Register.) This 

guidance reflects the Agency’s current 

thinking in light of data standards, 

information technology, and 

information management resources. As 

these variables change over time, FDA 

may revisit the guidance. 

In the Federal Register of September 

6, 2013 (78 FR 54899), FDA announced 

the availability of the draft guidance 

entitled ‘‘Specification of the Unique 

Facility Identifier (UFI) System for Drug 

Establishment Registration.’’ The notice 

gave the public an opportunity to 

comment by November 5, 2013. FDA 

carefully considered all comments 

received in preparing the guidance. No 

substantive changes were made in 

finalizing the guidance. 

This guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

This guidance represents the Agency’s 

current thinking on specification of the 

UFI system for drug establishment 

registration. 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. Paperwork Reduction Act of 1995 

This guidance contains collections of 

information that 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 have been 

approved under OMB control number 

0910–0045. 

III. 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. 

IV. Electronic Access 

Persons with access to the Internet 

may obtain the document at http://

www.fda.gov/Drugs/Guidance

ComplianceRegulatoryInformation/

Guidances/default.htm, http://

www.fda.gov/BiologicsBloodVaccines/

GuidanceComplianceRegulatory

Information/Guidances/default.htm, 

http://www.fda.gov/AnimalVeterinary/

GuidanceComplianceEnforcement/

GuidanceforIndustry/default.htm, or 

http://www.regulations.gov. 

Dated: November 3, 2014. 

Leslie Kux, 

Assistant Commissioner for Policy. 

[FR Doc. 2014–26397 Filed 11–5–14; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2007–D–0369, formerly 

2007D–0168] 

Bioequivalence Recommendations for 

CONCERTA (Methylphenidate 

Hydrochloride) Extended-Release 

Tablets; Draft Guidance for Industry; 

Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of a draft guidance for 

industry entitled ‘‘Bioequivalence 

Recommendations for CONCERTA 

(methylphenidate hydrochloride) 

Extended-Release Tablets.’’ The 

recommendations provide specific 

guidance on the design of 

bioequivalence (BE) studies to support 

abbreviated new drug applications 

(ANDAs) that reference the listed drug 

CONCERTA (methylphenidate 

hydrochloride (HCl)) extended-release 

tablets (new drug application (NDA) 

021121). The draft guidance is a revised 

version of a previously issued draft 

guidance on the same subject. 

DATES: Although you can comment on 

any guidance at any time (see 21 CFR 

10.115(g)(5)), to ensure that the Agency 

considers your comments on this draft 

guidance before it begins work on the 

final version of the guidance, submit 

either electronic or written comments 

on the draft guidance by January 5, 

2015. 

ADDRESSES: 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. 

Submit electronic comments on the 

draft guidance to http://

www.regulations.gov. Submit written 

comments to the Division of Dockets 

Management (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, Rm. 

1061, Rockville, MD 20852. 

FOR FURTHER INFORMATION CONTACT: Kris 

Andre ́, Center for Drug Evaluation and 

Research, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 75, Rm. 4726, Silver Spring, 

MD 20993–0002, 240–402–7959. 

mstockstill on DSK4VPTVN1PROD with NOTICES

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. 

mstockstill on DSK4VPTVN1PROD with NOTICES