Analytical Procedures and Methods Validation for Drugs and Biologics; Guidance for Industry; Availability, 44357-44358 [2015-18270]

Download as PDF Federal Register / Vol. 80, No. 143 / Monday, July 27, 2015 / Notices 44357 ESTIMATED ANNUALIZED BURDEN HOURS Form name International Panel Physicians (All sites). TB Indicators Excel Spreadsheet. TOTAL .......................... 353 .............................................. .............................. Leroy A. Richardson, Chief, Information Collection Review Office, Office of Scientific Integrity, Office of the Associate Director for Science, Office of the Director, Centers for Disease Control and Prevention. [FR Doc. 2015–18301 Filed 7–24–15; 8:45 am] BILLING CODE 4163–18–P ................................ 0910–0796. The approval expires on June 30, 2018. A copy of the supporting statement for this information collection is available on the Internet at http:// www.reginfo.gov/public/do/PRAMain. Dated: July 22, 2015. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2015–18295 Filed 7–24–15; 8:45 am] BILLING CODE 4164–01–P Food and Drug Administration DEPARTMENT OF HEALTH AND HUMAN SERVICES Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Generic Clearance for the Collection of Qualitative Data on Tobacco Products and Communications AGENCY: Food and Drug Administration, ACTION: [Docket No. FDA–2014–D–0103] Analytical Procedures and Methods Validation for Drugs and Biologics; Guidance for Industry; Availability AGENCY: ACTION: Notice. The Food and Drug Administration (FDA) is announcing that a collection of information entitled, ‘‘Generic Clearance for the Collection of Qualitative Data on Tobacco Products and Communications’’ has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995. FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations, Food and Drug Administration, 8455 Colesville Rd., COLE–14526, Silver Spring, MD 20993–0002, PRAStaff@ fda.hhs.gov. SUPPLEMENTARY INFORMATION: On December 10, 2014, the Agency submitted a proposed collection of information entitled, ‘‘Generic Clearance for the Collection of Qualitative Data on Tobacco Products and Communications’’ to OMB for review and clearance under 44 U.S.C. 3507. An Agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. OMB has now approved the information collection and has assigned OMB control number SUMMARY: tkelley on DSK3SPTVN1PROD with NOTICES Food and Drug Administration Food and Drug Administration, HHS. HHS. VerDate Sep<11>2014 18:58 Jul 24, 2015 Jkt 235001 Notice. The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ‘‘Analytical Procedures and Methods Validation for Drugs and Biologics.’’ This guidance supersedes the draft of the same name that published on February 19, 2014, and replaces the 2000 draft guidance for industry on ‘‘Analytical Procedures and Methods Validation’’ and the 1987 FDA guidance for industry on ‘‘Submitting Samples and Analytical Data for Methods Validation.’’ This guidance discusses how to submit analytical procedures and methods validation data to support the documentation of the identity, strength, quality, purity, and potency of drug substances and drug products. DATES: Submit either electronic or written comments on Agency guidances at any time. ADDRESSES: Submit written requests for single copies of this guidance to the Office of Communications, Division of Drug Information, Center for Drug Evaluation and Research, Food and Drug Administration, 10001 New Hampshire Ave., Hillandale Bldg., 4th SUMMARY: PO 00000 Frm 00035 Fmt 4703 Sfmt 4703 Total burden hours 7.5 2,648 .............................. 2,648 1 DEPARTMENT OF HEALTH AND HUMAN SERVICES [Docket No. FDA–2014–N–0987] Average burden per response (in hours) Number of responses per respondent Number of respondents Type of respondents Floor, Silver Spring, MD 20993, or to the Office of Communication, Outreach and Development, Center for Biologics Evaluation and Research (CBER), 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. The guidance may also be obtained by mail by calling CBER at 1–800–835–4709 or 240–402–7800. 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 Division of Dockets Management (HFA– 305), Food and Drug Administration, 5630 Fishers Lane, Room 1061, Rockville, MD 20852. FOR FURTHER INFORMATION CONTACT: Lucinda Buhse, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 2130, Silver Spring, MD 20993–0002, 240– 402–4595, or Stephen Ripley, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993–0002, 240–402–7911. SUPPLEMENTARY INFORMATION: I. Background FDA is announcing the availability of a guidance for industry entitled ‘‘Analytical Procedures and Methods Validation for Drugs and Biologics.’’ This guidance supersedes the draft of the same name that published on February 19, 2014, and replaces the 2000 draft guidance for industry on ‘‘Analytical Procedures and Methods Validation’’ and the 1987 FDA guidance for industry on ‘‘Submitting Samples and Analytical Data for Methods Validation.’’ It discusses how to submit analytical procedures and methods validation data to support the documentation of the identity, strength, quality, purity, and potency of drug substances and drug products, and how to assemble information and present E:\FR\FM\27JYN1.SGM 27JYN1 44358 Federal Register / Vol. 80, No. 143 / Monday, July 27, 2015 / Notices data to support analytical methodologies. The recommendations in this guidance apply to new drug applications, abbreviated new drug applications, biologics license applications, and supplements to these applications. The principles in this guidance also apply to Type II drug master files. This guidance does not address investigational new drug application (IND) methods validation specifically, but the principles being discussed may be helpful to sponsors preparing INDs. This guidance complements the International Conference on Harmonisation guidance ‘‘Q2(R1) Validation of Analytical Procedures: Text and Methodology.’’ In the Federal Register of February 19, 2014 (79 FR 9467), this guidance was published as a draft guidance. We have carefully reviewed and considered the comments that were received on the draft guidance and have made changes for clarification. This guidance is being issued consistent with FDA’s good guidance practices regulation (21 CFR 10.115). The guidance represents the current thinking of FDA on analytical procedures and methods validation. 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. II. The Paperwork Reduction Act of 1995 This guidance refers to previously approved 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 in 21 CFR part 211, 21 CFR part 314, and 21 CFR part 601 have been approved under OMB control numbers 0910–0139, 0910–0001, and 0910–0338. tkelley on DSK3SPTVN1PROD with NOTICES 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. VerDate Sep<11>2014 18:58 Jul 24, 2015 Jkt 235001 IV. Electronic Access Persons with access to the Internet may obtain the document at http:// www.fda.gov/Drugs/ GuidanceCompliance RegulatoryInformation/Guidances/ default.htm, http://www.fda.gov/ BiologicsBloodVaccines/ GuidanceCompliance RegulatoryInformation/default.htm, or http://www.regulations.gov. Dated: July 21, 2015. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2015–18270 Filed 7–24–15; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration Statement of Organization, Functions and Delegations of Authority This notice amends part R of the Statement of Organization, Functions and Delegations of Authority of the Department of Health and Human Services (HHS), Health Resources and Services Administration (HRSA) (60 FR 56605, as amended November 6, 1995; as last amended at 80 FR 37639–37640 dated July 1, 2015). This notice reflects organizational changes in the Health Resources and Services Administration (HRSA), Maternal and Child Health Bureau (RM). Specifically, this notice: (1) Establishes the Office of Policy and Planning (RMA); (2) transfers the current Office of Policy Coordination (RM10) function to the newly established Office of Policy and Planning (RMA); and (3) abolishes the Office of Policy and Coordination (RM10). Chapter RM—Maternal and Child Health Bureau Section RM—00, Mission To provide national leadership, in partnership with key stakeholders, to improve the physical and mental health, safety and well-being of the maternal and child health (MCH) population which includes all of the nation’s women, infants, children, adolescents, and their families, including fathers and children with special health care needs. Section RM–10, Organization Delete the organization for the Maternal and Child Health Bureau (RM) in its entirety and replace with the following: PO 00000 Frm 00036 Fmt 4703 Sfmt 4703 The Maternal and Child Health Bureau (RM) is headed by the Associate Administrator, who reports directly to the Administrator, Health Resources and Services Administration. The Maternal and Child Health Bureau includes the following components: (1) Office of the Associate Administrator (RM); (2) Office of Operations and Management (RM1); (3) Office of Policy and Planning (RMA); (4) Division of Services for Children with Special Health Needs (RM2); (5) Division of Child, Adolescent and Family Health (RM3); (6) Division of MCH Workforce Development (RM4); (7) Division of Healthy Start and Perinatal Services (RM5); (8) Division of State and Community Health (RM6); (9) Division of Home Visiting and Early Childhood Systems (RM8); and (10) Office of Epidemiology and Research (RM9). Section RM–20, Functions This notice reflects organizational changes in the Health Resources and Services Administration (HRSA), Maternal and Child Health Bureau (RM). Specifically, this notice: (1) Establishes the Office of Policy and Planning (RMA); (2) transfers the Office of Policy Coordination (RM10) function to the newly established Office of Policy and Planning (RMA); and (3) abolishes the Office of Policy and Coordination (RM10). Delete the function for the Office of Policy Coordination (RM10), and replace in its entirety. Office of Policy and Planning (RMA) The Office of Policy and Planning (OPP) serves as the Maternal and Child Health Bureau (MCHB) focal point for the development of MCHB policy and program planning. Specifically, the Office: (1) Supports the Office of the Associate Administrator in identifying, planning, and implementing policy and program priorities across MCHB; (2) works closely with the Office of the Associate Administrator to develop strategic plans, facilitate program alignment, and support special initiatives; (3) advises and assists in the development, coordination and management of program and policy documents, and responses to departmental and HRSA initiatives; and (4) coordinates with other components within HRSA and HHS, federal agencies, state and local governments, and other public and private organizations on issues affecting MCHB programs and policies. E:\FR\FM\27JYN1.SGM 27JYN1

Agencies

[Federal Register Volume 80, Number 143 (Monday, July 27, 2015)]
[Notices]
[Pages 44357-44358]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-18270]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-D-0103]


Analytical Procedures and Methods Validation for Drugs and 
Biologics; 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 ``Analytical 
Procedures and Methods Validation for Drugs and Biologics.'' This 
guidance supersedes the draft of the same name that published on 
February 19, 2014, and replaces the 2000 draft guidance for industry on 
``Analytical Procedures and Methods Validation'' and the 1987 FDA 
guidance for industry on ``Submitting Samples and Analytical Data for 
Methods Validation.'' This guidance discusses how to submit analytical 
procedures and methods validation data to support the documentation of 
the identity, strength, quality, purity, and potency of drug substances 
and drug products.

DATES: Submit either electronic or written comments on Agency guidances 
at any time.

ADDRESSES: Submit written requests for single copies of this guidance 
to the Office of Communications, Division of Drug Information, Center 
for Drug Evaluation and Research, Food and Drug Administration, 10001 
New Hampshire Ave., Hillandale Bldg., 4th Floor, Silver Spring, MD 
20993, or to the Office of Communication, Outreach and Development, 
Center for Biologics Evaluation and Research (CBER), 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. The guidance may also be 
obtained by mail by calling CBER at 1-800-835-4709 or 240-402-7800. 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 Division of Dockets 
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, 
Room 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Lucinda Buhse, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 22, Rm. 2130, Silver Spring, MD 20993-0002, 240-
402-4595, or Stephen Ripley, Center for Biologics Evaluation and 
Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 
71, Rm. 7301, Silver Spring, MD 20993-0002, 240-402-7911.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a guidance for industry 
entitled ``Analytical Procedures and Methods Validation for Drugs and 
Biologics.'' This guidance supersedes the draft of the same name that 
published on February 19, 2014, and replaces the 2000 draft guidance 
for industry on ``Analytical Procedures and Methods Validation'' and 
the 1987 FDA guidance for industry on ``Submitting Samples and 
Analytical Data for Methods Validation.'' It discusses how to submit 
analytical procedures and methods validation data to support the 
documentation of the identity, strength, quality, purity, and potency 
of drug substances and drug products, and how to assemble information 
and present

[[Page 44358]]

data to support analytical methodologies. The recommendations in this 
guidance apply to new drug applications, abbreviated new drug 
applications, biologics license applications, and supplements to these 
applications. The principles in this guidance also apply to Type II 
drug master files. This guidance does not address investigational new 
drug application (IND) methods validation specifically, but the 
principles being discussed may be helpful to sponsors preparing INDs.
    This guidance complements the International Conference on 
Harmonisation guidance ``Q2(R1) Validation of Analytical Procedures: 
Text and Methodology.''
    In the Federal Register of February 19, 2014 (79 FR 9467), this 
guidance was published as a draft guidance. We have carefully reviewed 
and considered the comments that were received on the draft guidance 
and have made changes for clarification.
    This guidance is being issued consistent with FDA's good guidance 
practices regulation (21 CFR 10.115). The guidance represents the 
current thinking of FDA on analytical procedures and methods 
validation. 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.

II. The Paperwork Reduction Act of 1995

    This guidance refers to previously approved 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 in 21 CFR part 211, 21 CFR part 
314, and 21 CFR part 601 have been approved under OMB control numbers 
0910-0139, 0910-0001, and 0910-0338.

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/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/default.htm, or http://www.regulations.gov.

    Dated: July 21, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-18270 Filed 7-24-15; 8:45 am]
BILLING CODE 4164-01-P