Controlled Correspondence Related to Generic Drug Development; Draft Guidance for Industry; Availability; Correction, 54386-54387 [2017-24948]

Download as PDF 54386 Federal Register / Vol. 82, No. 221 / Friday, November 17, 2017 / Notices and other applicable disclosure law. For more information about FDA’s posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: https://www.gpo.gov/ fdsys/pkg/FR-2015-09-18/pdf/201523389.pdf. Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to https:// www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the ‘‘Search’’ box and follow the prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. You may submit comments on any guidance at any time (see 21 CFR 10.115(g)(5)). Submit written requests for single copies of the draft guidance to the Office of Communication, Outreach and Development, Center for Biologics Evaluation and Research (CBER), Food and Drug Administration, 10903 New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 the office in processing your requests. The draft guidance may also be obtained by mail by calling CBER at 1– 800–835–4709 or 240–402–8010. See the SUPPLEMENTARY INFORMATION section for electronic access to the draft guidance document. FOR FURTHER INFORMATION CONTACT: Tami Belouin, 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: sradovich on DSK3GMQ082PROD with NOTICES I. Background FDA is announcing the availability of a draft document entitled ‘‘Expedited Programs for Regenerative Medicine Therapies for Serious Conditions; Draft Guidance for Industry.’’ The draft guidance document describes the expedited programs available to sponsors of regenerative medicine therapies for serious or life-threatening diseases or conditions (referred to in the draft guidance as serious conditions), including those products designated as RMATs; provides information about the provisions in the 21st Century Cures Act (Cures Act) (Pub. L. 114–225) regarding the use of the accelerated approval pathway for regenerative medicine therapies that have been granted designation as an RMAT; describes how CBER will encourage flexibility in clinical trial design to facilitate the VerDate Sep<11>2014 18:32 Nov 16, 2017 Jkt 244001 development of data to demonstrate the safety and effectiveness of regenerative medicine therapies that are being developed to address unmet needs in patients with serious conditions; and describes the opportunities for sponsors of regenerative medicine therapies to interact with CBER review staff. The draft guidance document addresses regenerative medicine therapies, which are defined in section 506(g)(8) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Cures Act, as including cell therapies, therapeutic tissue engineering products, human cell and tissue products, and combination products using any such therapies or products, except for those regulated solely under section 361 of the Public Health Service Act (PHS Act) (42 U.S.C. 264) and 21 CFR part 1271. Gene therapies, including genetically modified cells, that lead to a durable modification of cells or tissues can meet the definition of a regenerative medicine therapy. Under section 506(g) of the FD&C Act, RMAT designation is available for a drug (i.e., a human drug, including a drug that is a biological product) that meets the definition of regenerative medicine therapy; is intended to treat, modify, reverse, or cure a serious or life-threatening disease or condition; and with respect to which preliminary clinical evidence indicates the potential to address unmet medical needs for such disease or condition. A combination product (biologic-device, biologic-drug, or biologic-device-drug) can be eligible for RMAT designation when the biological product provides the greatest contribution to the overall intended therapeutic effects of the combination product (i.e., the primary mode of action in the combination product is conveyed by the biological product component). Elsewhere in this issue of the Federal Register, FDA is announcing the availability of a document entitled ‘‘Evaluation of Devices Used with Regenerative Medicine Advanced Therapies; Draft Guidance for Industry.’’ 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 current thinking of FDA on ‘‘Expedited Programs for Regenerative Medicine Therapies for Serious Conditions; Draft Guidance for Industry.’’ 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. This guidance is not subject to Executive Order 12866. PO 00000 Frm 00071 Fmt 4703 Sfmt 4703 II. Paperwork Reduction Act of 1995 This 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 part 312 have been approved under OMB control number 0910–0014; the collections of information regarding formal meetings in ‘‘Guidance for Formal Meetings Between the FDA and Sponsors or Applicants of PDUFA Products’’ have been approved under OMB control number 0910–0429; the collections of information in 21 CFR part 601 have been approved under OMB control number 0910–0338; the collections of information for expedited programs in ‘‘Guidance for Industry: Expedited Programs for Serious Conditions—Drugs and Biologics,’’ have been approved under OMB control number 0910–0765; the collections of information in 21 CFR part 314 have been approved under OMB control number 0910–0001. III. Electronic Access Persons with access to the Internet may obtain the draft guidance at either https://www.fda.gov/ BiologicsBloodVaccines/ GuidanceCompliance RegulatoryInformation/Guidances/ default.htm or https:// www.regulations.gov. Dated: November 13, 2017. Anna K. Abram, Deputy Commissioner for Policy, Planning, Legislation, and Analysis. [FR Doc. 2017–24837 Filed 11–16–17; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2014–D–1167] Controlled Correspondence Related to Generic Drug Development; Draft Guidance for Industry; Availability; Correction AGENCY: Food and Drug Administration, HHS. ACTION: Notice; correction. The Food and Drug Administration is correcting a notice entitled ‘‘Controlled Correspondence Related to Generic Drug Development; Draft Guidance for Industry; Availability’’ that appeared in the SUMMARY: E:\FR\FM\17NON1.SGM 17NON1 Federal Register / Vol. 82, No. 221 / Friday, November 17, 2017 / Notices Federal Register of November 3, 2017. The document announced the availability of a draft guidance for industry. The document was published with the incorrect docket number. This document corrects that error. FOR FURTHER INFORMATION CONTACT: Lisa Granger, Office of Policy, Food and Drug Administration, 10903 New Hampshire Ave. Bldg. 32, Rm. 3330, Silver Spring, MD 20993–0002, 301–796–9115, lisa.granger@fda.hhs.gov. SUPPLEMENTARY INFORMATION: In the Federal Register of Friday, November 3, 2017 (82 FR 51277), in FR Doc. 2017– 23947, the following correction is made: On page 51277, in the second column, in the header of the document, ‘‘[Docket FDA–2014–D–1147]’’ is corrected to read ‘‘[Docket No. FDA–2014–D–1167]’’. Dated: November 9, 2017. Anna K. Abram, Deputy Commissioner for Policy, Planning, Legislation, and Analysis. [FR Doc. 2017–24948 Filed 11–16–17; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2015–D–2245] Unique Device Identification: Direct Marking of Devices; Guidance for Industry and Food and Drug Administration Staff; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice of availability. The Food and Drug Administration (FDA or Agency) is announcing the availability of the guidance entitled ‘‘Unique Device Identification: Direct Marking of Devices.’’ This document is intended to clarify when direct marking of devices with a unique device identifier (UDI) is required, and to assist industry and FDA staff in understanding direct marking requirements. DATES: The announcement of the guidance is published in the Federal Register on November 17, 2017. ADDRESSES: You may submit either electronic or written comments on Agency guidances at any time as follows: sradovich on DSK3GMQ082PROD with NOTICES SUMMARY: Electronic Submissions Submit electronic comments in the following way: • Federal eRulemaking Portal: https://www.regulations.gov. Follow the instructions for submitting comments. VerDate Sep<11>2014 18:32 Nov 16, 2017 Jkt 244001 Comments submitted electronically, including attachments, to https://www. regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else’s Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on https://www.regulations.gov. • If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see ‘‘Written/Paper Submissions’’ and ‘‘Instructions’’). Written/Paper Submissions Submit written/paper submissions as follows: • Mail/Hand delivery/Courier (for written/paper submissions): Dockets Management Staff (HFA–305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. • For written/paper comments submitted to the Dockets Management Staff, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in ‘‘Instructions.’’ Instructions: All submissions received must include the Docket No. FDA– 2015–D–2245 for ‘‘Unique Device Identification: Direct Marking of Devices.’’ Received comments will be placed in the docket and, except for those submitted as ‘‘Confidential Submissions,’’ publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday. • Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states ‘‘THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.’’ The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information PO 00000 Frm 00072 Fmt 4703 Sfmt 4703 54387 redacted/blacked out, will be available for public viewing and posted on https://www.regulations.gov. Submit both copies to the Dockets Management Staff. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as ‘‘confidential.’’ Any information marked as ‘‘confidential’’ will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA’s posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: https://www.gpo.gov/ fdsys/pkg/FR-2015-09-18/pdf/201523389.pdf. Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to https://www.regulations. gov and insert the docket number, found in brackets in the heading of this document, into the ‘‘Search’’ box and follow the prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. You may submit comments on any guidance at any time (see 21 CFR 10.115(g)(5)). An electronic copy of the guidance document is available for download from the internet. See the SUPPLEMENTARY INFORMATION section for information on electronic access to the guidance. Submit written requests for a single hard copy of the guidance document entitled ‘‘Unique Device Identification: Direct Marking of Devices’’ to the Office of the Center Director, Guidance and Policy Development, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5431, Silver Spring, MD 20993–0002, 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 request. FOR FURTHER INFORMATION CONTACT: Christina Savisaar, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 3303, Silver Spring, MD 20993–0002, 301–496–6404, email: GUDIDSupport@fda.hhs.gov. SUPPLEMENTARY INFORMATION: E:\FR\FM\17NON1.SGM 17NON1

Agencies

[Federal Register Volume 82, Number 221 (Friday, November 17, 2017)]
[Notices]
[Pages 54386-54387]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-24948]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-D-1167]


Controlled Correspondence Related to Generic Drug Development; 
Draft Guidance for Industry; Availability; Correction

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; correction.

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SUMMARY: The Food and Drug Administration is correcting a notice 
entitled ``Controlled Correspondence Related to Generic Drug 
Development; Draft Guidance for Industry; Availability'' that appeared 
in the

[[Page 54387]]

Federal Register of November 3, 2017. The document announced the 
availability of a draft guidance for industry. The document was 
published with the incorrect docket number. This document corrects that 
error.

FOR FURTHER INFORMATION CONTACT: Lisa Granger, Office of Policy, Food 
and Drug Administration, 10903 New Hampshire Ave. Bldg. 32, Rm. 3330, 
Silver Spring, MD 20993-0002, 301-796-9115, lisa.granger@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: In the Federal Register of Friday, November 
3, 2017 (82 FR 51277), in FR Doc. 2017-23947, the following correction 
is made:
    On page 51277, in the second column, in the header of the document, 
``[Docket FDA-2014-D-1147]'' is corrected to read ``[Docket No. FDA-
2014-D-1167]''.

    Dated: November 9, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-24948 Filed 11-16-17; 8:45 am]
 BILLING CODE 4164-01-P