Draft Guidance for Industry on Rheumatoid Arthritis: Developing Drug Products for Treatment; Availability, 32667-32668 [2013-12922]

Download as PDF Federal Register / Vol. 78, No. 105 / Friday, May 31, 2013 / Notices Families is soliciting public comment on the specific aspects of the information collection described above. Copies of the proposed collection of information can be obtained and comments may be forwarded by writing to the Administration for Children and Families, Office of Planning, Research and Evaluation, 370 L’Enfant Promenade SW., Washington, DC 20447, Attn: OPRE Reports Clearance Officer. Email address: OPREinfocollection@acf.hhs.gov. All requests should be identified by the title of the information collection. The Department specifically requests comments on (a) whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency’s estimate of the burden of the proposed collection of information; (c) the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology. Consideration will be given to comments and suggestions submitted within 60 days of this publication. Steven M. Hanmer, Reports Clearance Officer. [FR Doc. 2013–12904 Filed 5–30–13; 8:45 am] BILLING CODE 4184–09–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2013–D–0571] Draft Guidance for Industry on Rheumatoid Arthritis: Developing Drug Products for Treatment; Availability AGENCY: Food and Drug Administration, HHS. tkelley on DSK3SPTVN1PROD with NOTICES ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ‘‘Rheumatoid Arthritis: Developing Drug Products for Treatment.’’ This guidance outlines FDA’s current thinking on the principles of clinical development relevant to dose-selection and assessment of efficacy and safety to support the approval of drug products for the treatment of patients with rheumatoid arthritis (RA). It also addresses additional considerations for VerDate Mar<15>2010 17:40 May 30, 2013 Jkt 229001 drug products developed as drug-device combination products. This guidance revises the guidance for industry entitled ‘‘Clinical Development Programs for Drugs, Devices, and Biological Products for the Treatment of Rheumatoid Arthritis (RA),’’ published in February 1999. Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment 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 July 30, 2013. DATES: Submit written requests for single copies of this guidance to the Division of Drug Information, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 2201, Silver Spring, MD 20993–0002; or Office of Communication, Outreach, and Development (HFM–40), Center for Biologics Evaluation and Research, Food and Drug Administration, 1401 Rockville Pike, suite 200N, Rockville, MD 20852–1448; or the Division of Small Manufacturers, International, and Consumer Assistance, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 4613, 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. ADDRESSES: FOR FURTHER INFORMATION CONTACT: Nikolay Nikolov, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 3335, Silver Spring, MD 20993–0002, 301– 796–5281; or Stephen Ripley, Center for Biologics Evaluation and Research (HFM–17), Food and Drug Administration, 1401 Rockville Pike, suite 200N, Rockville, MD 20852–1448, 301–827–6210; or Markham Luke Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 1680, Silver Spring, MD 20993–0002, 301–796–5556. SUPPLEMENTARY INFORMATION: PO 00000 Frm 00046 Fmt 4703 Sfmt 4703 32667 I. Background FDA is announcing the availability of a draft guidance for industry entitled ‘‘Rheumatoid Arthritis: Developing Drug Products for Treatment.’’ This draft guidance reflects current FDA thinking on RA drug product development. FDA’s current thinking has been influenced by clinical development programs conducted for RA since the 1999 guidance published, and by changes in the standard of care for RA because of availability of many effective treatments. RA drug product development has evolved to reflect the current status of the RA therapeutic armamentarium, good clinical practice, and treatment goals. The draft guidance addresses: • Dose(s) and dosing regimen(s) selection throughout the clinical development program. • Expectations for establishing efficacy in RA based on signs and symptoms and physical function domains. • Use of efficacy endpoints such as clinical remission and prevention of structural damage progression. • Limiting the use of placebo. • Use of active comparator for safety and efficacy trials. • Principles of safety assessment. • Development of drug-device combination products. 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 developing drug products for the treatment of RA. 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 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 parts 312 and 314 have been approved under OMB control numbers 0910–0014 and 0910– 0001, respectively. 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 E:\FR\FM\31MYN1.SGM 31MYN1 32668 Federal Register / Vol. 78, No. 105 / Friday, May 31, 2013 / Notices 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/default.htm, https:// www.fda.gov/MedicalDevices/Device RegulationandGuidance/Guidance Documents/default.htm, or https:// www.regulations.gov. Dated: May 24, 2013. Leslie Kux, Assistant Commissioner for Policy. [FR Doc. 2013–12922 Filed 5–30–13; 8:45 am] BILLING CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–1999–D–3528 (Formerly Docket No. 99D–5046)] Draft Guidance for Industry: Changes to an Approved Application: Biological Products: Human Blood and Blood Components Intended for Transfusion or for Further Manufacture; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is announcing the availability of a draft document entitled ‘‘Guidance for Industry: Changes to an Approved Application: Biological Products: Human Blood and Blood Components Intended for Transfusion or for Further Manufacture’’ dated June 2013. The draft guidance document provides manufacturers of licensed Whole Blood and blood components intended for transfusion or for further manufacture, including Source Plasma, with recommendations intended to assist with determining which reporting mechanism is appropriate for submission of changes to an approved biologics license application. The guidance document also provides manufacturers of licensed Whole Blood and blood components recommendations in connection with the applicability and content of tkelley on DSK3SPTVN1PROD with NOTICES SUMMARY: VerDate Mar<15>2010 17:40 May 30, 2013 Jkt 229001 comparability protocols and labeling changes. The draft guidance, when finalized, is intended to supersede the document of the same title dated July 2001 (July 2001 guidance). 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 comment 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 August 29, 2013. ADDRESSES: Submit written requests for single copies of the draft guidance to the Office of Communication, Outreach and Development (HFM–40), Center for Biologics Evaluation and Research (CBER), Food and Drug Administration, 1401 Rockville Pike, Suite 200N, Rockville, MD 20852–1448. Send one self-addressed adhesive label to assist the office in processing your requests. The draft guidance may also be obtained by mail by calling CBER at 1–800–835– 4709 or 301–827–1800. 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: Jonathan R. McKnight, Center for Biologics Evaluation and Research (HFM–17), Food and Drug Administration, 1401 Rockville Pike, Suite 200N, Rockville, MD 20852–1448, 301–827–6210. SUPPLEMENTARY INFORMATION: I. Background FDA is announcing the availability of a draft document entitled ‘‘Guidance for Industry: Changes to an Approved Application: Biological Products: Human Blood and Blood Components Intended for Transfusion or for Further Manufacture’’ dated June 2013. The document provides manufacturers of licensed Whole Blood and blood components intended for transfusion or for further manufacture, including Source Plasma, with recommendations intended to assist with determining which reporting mechanism is appropriate for submission of changes to an approved biologics license application in accordance with the requirements under Title 21 Code of Federal Regulations 601.12 (21 CFR 601.12). The guidance document also provides manufacturers of licensed PO 00000 Frm 00047 Fmt 4703 Sfmt 4703 Whole Blood and blood components with recommendations in connection with the applicability and content of comparability protocols under 21 CFR 601.12(e) and labeling changes under 21 CFR 601.12(f). Frequently, a manufacturer of a licensed product determines that it is appropriate to make a change in its product, production process, quality controls, equipment, facilities, responsible personnel, or labeling as documented in its approved biologics license application(s). Section 601.12 (21 CFR 601.12) states the requirements to report such changes for licensed biological products to FDA. The recommendations contained in the guidance document reflect current FDA and industry experience with reporting changes to an approved application, including reporting the implementation of new technologies. The recommendations have been revised for reporting categories for certain changes to an approved application that is in the July 2001 guidance based on the experience gained over the last decade. The draft guidance, when finalized, is intended to supersede the document of the same title dated July 2001, published in the Federal Register of August 7, 2001 (66 FR 41247). The draft guidance is being issued consistent with FDA’s good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent FDA’s current thinking on this topic. 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 requirement of the applicable statutes and regulations. II. Paperwork Reduction Act of 1995 The draft guidance refers to previously approved collections of information found in FDA regulations. These collections of information 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 601.12, Form FDA 2567, and Form FDA 356h have been approved under OMB control number 0910–0338; the collections of information in 21 CFR 607.21, 607.26, and Form FDA 2830 have been approved under OMB control number 0910–0052; the collections of information in 21 CFR 606.121, 606.170, and 610.40 have been approved under OMB control number 0910–0116; and the collections of information in 21 CFR 600.14 has been approved under OMB control number 0910–0458. E:\FR\FM\31MYN1.SGM 31MYN1

Agencies

[Federal Register Volume 78, Number 105 (Friday, May 31, 2013)]
[Notices]
[Pages 32667-32668]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-12922]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-D-0571]


Draft Guidance for Industry on Rheumatoid Arthritis: Developing 
Drug Products for Treatment; 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 ``Rheumatoid 
Arthritis: Developing Drug Products for Treatment.'' This guidance 
outlines FDA's current thinking on the principles of clinical 
development relevant to dose-selection and assessment of efficacy and 
safety to support the approval of drug products for the treatment of 
patients with rheumatoid arthritis (RA). It also addresses additional 
considerations for drug products developed as drug-device combination 
products. This guidance revises the guidance for industry entitled 
``Clinical Development Programs for Drugs, Devices, and Biological 
Products for the Treatment of Rheumatoid Arthritis (RA),'' published in 
February 1999.

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 comment 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 July 30, 2013.

ADDRESSES: Submit written requests for single copies of this guidance 
to the Division of Drug Information, Center for Drug Evaluation and 
Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 
51, Rm. 2201, Silver Spring, MD 20993-0002; or Office of Communication, 
Outreach, and Development (HFM-40), Center for Biologics Evaluation and 
Research, Food and Drug Administration, 1401 Rockville Pike, suite 
200N, Rockville, MD 20852-1448; or the Division of Small Manufacturers, 
International, and Consumer Assistance, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, Rm. 4613, 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: Nikolay Nikolov, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 22, Rm. 3335, Silver Spring, MD 20993-0002, 301-
796-5281; or Stephen Ripley, Center for Biologics Evaluation and 
Research (HFM-17), Food and Drug Administration, 1401 Rockville Pike, 
suite 200N, Rockville, MD 20852-1448, 301-827-6210; or Markham Luke 
Center for Devices and Radiological Health, Food and Drug 
Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 1680, Silver 
Spring, MD 20993-0002, 301-796-5556.

SUPPLEMENTARY INFORMATION: 

I. Background

    FDA is announcing the availability of a draft guidance for industry 
entitled ``Rheumatoid Arthritis: Developing Drug Products for 
Treatment.'' This draft guidance reflects current FDA thinking on RA 
drug product development. FDA's current thinking has been influenced by 
clinical development programs conducted for RA since the 1999 guidance 
published, and by changes in the standard of care for RA because of 
availability of many effective treatments. RA drug product development 
has evolved to reflect the current status of the RA therapeutic 
armamentarium, good clinical practice, and treatment goals.
    The draft guidance addresses:
     Dose(s) and dosing regimen(s) selection throughout the 
clinical development program.
     Expectations for establishing efficacy in RA based on 
signs and symptoms and physical function domains.
     Use of efficacy endpoints such as clinical remission and 
prevention of structural damage progression.
     Limiting the use of placebo.
     Use of active comparator for safety and efficacy trials.
     Principles of safety assessment.
     Development of drug-device combination products.
    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 developing 
drug products for the treatment of RA. 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 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 parts 312 and 314 have 
been approved under OMB control numbers 0910-0014 and 0910-0001, 
respectively.

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

[[Page 32668]]

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/default.htm, https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm, or https://www.regulations.gov.

    Dated: May 24, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-12922 Filed 5-30-13; 8:45 am]
BILLING CODE 4160-01-P
This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.