Federal Register / Vol. 79, No. 215 / Thursday, November 6, 2014 / Notices 65977 

1There are no capital costs or operating and 

maintenance costs associated with this collection of 

information. 

Office of Management and Budget 

(OMB) for each collection of 

information they conduct or sponsor. 

‘‘Collection of information’’ is defined 

in 44 U.S.C. 3502(3) and 5 CFR 

1320.3(c) and includes Agency requests 

or requirements that members of the 

public submit reports, keep records, or 

provide information to a third party. 

Section 3506(c)(2)(A) of the PRA (44 

U.S.C. 3506(c)(2)(A)) requires Federal 

Agencies to provide a 60-day notice in 

the Federal Register concerning each 

proposed collection of information, 

including each proposed extension of an 

existing collection of information, 

before submitting the collection to OMB 

for approval. To comply with this 

requirement, FDA is publishing notice 

of the proposed collection of 

information set forth in this document. 

With respect to the following 

collection of information, FDA invites 

comments on these topics: (1) Whether 

the proposed collection of information 

is necessary for the proper performance 

of FDA’s functions, including whether 

the information will have practical 

utility; (2) the accuracy of FDA’s 

estimate of the burden of the proposed 

collection of information, including the 

validity of the methodology and 

assumptions used; (3) ways to enhance 

the quality, utility, and clarity of the 

information to be collected; and (4) 

ways to minimize the burden of the 

collection of information on 

respondents, including through the use 

of automated collection techniques, 

when appropriate, and other forms of 

information technology. 

Appeals of Science-Based Decisions 

Above the Division Level at CVM—21 

CFR Part 10.75 (OMB Control Number 

0910–0566)—Revision 

Respondents: Respondents to this 

collection of information are applicants 

that wish to submit a request for review 

of a scientific dispute. 

CVM’s Guidance for Industry #79— 

‘‘Dispute Resolution Procedures for 

Science-based Decisions on Products 

Regulated by the Center for Veterinary 

Medicine,’’ describes the process by 

which CVM formally resolves disputes 

relating to scientific controversies. A 

scientific controversy involves issues 

concerning a specific product regulated 

by CVM related to matters of technical 

expertise and requires specialized 

education, training, or experience to be 

understood and resolved. Further, the 

guidance details information on how the 

Agency intends to interpret and apply 

provisions of the existing regulations 

regarding internal Agency review of 

decisions. In addition, the guidance 

outlines the established procedures for 

persons who are sponsors, applicants or 

manufacturers, for animal drugs or other 

products regulated by CVM, that wish to 

submit a request for review of a 

scientific dispute. When a sponsor, 

applicant, or manufacturer has a 

scientific disagreement with a written 

decision by CVM, they may submit a 

request for a review of that decision by 

following the established Agency 

channels of supervision for review. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

21 CFR Section Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average 

burden per 

response 

Total hours 

10.75 .................................................................................... 2 4 8 10 80 

CVM encourages applicants to begin 

the resolution of science-based disputes 

with discussions with the review team/ 

group, including the Team Leader or 

Division Director. The Center prefers 

that differences of opinion regarding 

science or science-based policy be 

resolved between the review team/group 

and the applicant. If the matter is not 

resolved by this preferred method, then 

CVM recommends that the applicant 

follow the procedure in Guidance for 

Industry #79. Of the two respondents 

who were advised on the procedure 

during the past 3 years, one has not 

followed up to initiate it and the other 

is working with the review team/group 

to resolve the issue(s). Therefore, this 

estimated annual reporting burden is 

based on CVM’s previous experience in 

handling formal appeals for scientific 

disputes. 

Dated: October 31, 2014. 

Leslie Kux, 

Assistant Commissioner for Policy. 

[FR Doc. 2014–26307 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–2013–D–0984] 

Specification of the Unique Facility 

Identifier System for Drug 

Establishment Registration; 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 guidance for industry 

entitled ‘‘Specification of the Unique 

Facility Identifier (UFI) System for Drug 

Establishment Registration.’’ This 

guidance specifies the UFI system for 

registration of domestic and foreign 

drug establishments. The guidance 

addresses provisions set forth in the 

Federal Food, Drug, and Cosmetic Act 

(the FD&C Act), as amended by the Food 

and Drug Administration Safety and 

Innovation Act (FDASIA). This 

guidance finalizes the draft guidance 

issued on September 6, 2013. 

DATES: Submit either electronic or 

written comments on Agency guidances 

at any time. 

ADDRESSES: Submit written requests for 

single copies of the 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; or 

the Office of Communication, Outreach 

and Development, Center for Biologics 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 71, Rm. 3128, 

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 guidance document. 

Submit electronic comments on the 

guidance to http://www.regulations.gov. 

Submit written comments to the 

mstockstill on DSK4VPTVN1PROD with NOTICES

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