Specification of the Unique Facility Identifier System for Drug Establishment Registration; Guidance for Industry; Availability, 65977-65978 [2014-26397]

Download as PDF Federal Register / Vol. 79, No. 215 / Thursday, November 6, 2014 / Notices 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 65977 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 mstockstill on DSK4VPTVN1PROD with NOTICES 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. 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 SUMMARY: Innovation Act (FDASIA). This guidance finalizes the draft guidance issued on September 6, 2013. Submit either electronic or written comments on Agency guidances at any time. DATES: 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 https://www.regulations.gov. Submit written comments to the ADDRESSES: 1 There are no capital costs or operating and maintenance costs associated with this collection of information. VerDate Sep<11>2014 19:46 Nov 05, 2014 Jkt 235001 PO 00000 Frm 00056 Fmt 4703 Sfmt 4703 E:\FR\FM\06NON1.SGM 06NON1 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: mstockstill on DSK4VPTVN1PROD with NOTICES 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 https://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 VerDate Sep<11>2014 19:46 Nov 05, 2014 Jkt 235001 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 https://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 https:// www.regulations.gov. IV. Electronic Access Persons with access to the Internet may obtain the document at https:// www.fda.gov/Drugs/Guidance ComplianceRegulatoryInformation/ Guidances/default.htm, https:// www.fda.gov/BiologicsBloodVaccines/ GuidanceComplianceRegulatory Information/Guidances/default.htm, https://www.fda.gov/AnimalVeterinary/ GuidanceComplianceEnforcement/ GuidanceforIndustry/default.htm, or https://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 PO 00000 Frm 00057 Fmt 4703 Sfmt 4703 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. 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 https:// 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. SUMMARY: E:\FR\FM\06NON1.SGM 06NON1

Agencies

[Federal Register Volume 79, Number 215 (Thursday, November 6, 2014)]
[Notices]
[Pages 65977-65978]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-26397]


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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 https://www.regulations.gov. Submit written comments to the

[[Page 65978]]

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 https://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 https://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 https://www.regulations.gov.

IV. Electronic Access

    Persons with access to the Internet may obtain the document at 
https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, https://www.fda.gov/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/default.htm, or https://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
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