82 FR 54386 - Controlled Correspondence Related to Generic Drug Development; Draft Guidance for Industry; Availability; Correction
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 82, Issue 221 (November 17, 2017)
Food and Drug Administration
Federal Register Volume 82, Issue 221 (November 17, 2017)
| Page Range | 54386-54387 | |
| FR Document | 2017-24948 |
[Federal Register Volume 82, Number 221 (Friday, November 17, 2017)] [Notices] [Pages 54386-54387] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-24948] ----------------------------------------------------------------------- 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and Drug Administration [Docket No. FDA-2014-D-1167] Controlled Correspondence Related to Generic Drug Development; Draft Guidance for Industry; Availability; Correction AGENCY: Food and Drug Administration, HHS.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. ----------------------------------------------------------------------- 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Drug Administration is correcting a notice entitled ``Controlled Correspondence Related to Generic Drug Development; Draft Guidance for Industry; Availability'' that appeared in the [[Page 54387]] Federal Register of November 3, 2017. The document announced the availability of a draft guidance for industry.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, [email protected]. 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
![54386 Federal Register / Vol. 82, No. 221 / Friday, November 17, 2017 / Notices
and other applicable disclosure law. For development of data to demonstrate the II. Paperwork Reduction Act of 1995
more information about FDA’s posting safety and effectiveness of regenerative This draft guidance refers to
of comments to public dockets, see 80 medicine therapies that are being previously approved collections of
FR 56469, September 18, 2015, or access developed to address unmet needs in information found in FDA regulations.
the information at: https://www.gpo.gov/ patients with serious conditions; and These collections of information are
fdsys/pkg/FR-2015-09-18/pdf/2015- describes the opportunities for sponsors subject to review by the Office of
23389.pdf. of regenerative medicine therapies to Management and Budget (OMB) under
Docket: For access to the docket to interact with CBER review staff. the Paperwork Reduction Act of 1995
read background documents or the The draft guidance document
(44 U.S.C. 3501–3520). The collections
electronic and written/paper comments addresses regenerative medicine
of information in 21 CFR part 312 have
received, go to https:// therapies, which are defined in section
506(g)(8) of the Federal Food, Drug, and been approved under OMB control
www.regulations.gov and insert the number 0910–0014; the collections of
docket number, found in brackets in the Cosmetic Act (the FD&C Act), as
amended by the Cures Act, as including information regarding formal meetings
heading of this document, into the in ‘‘Guidance for Formal Meetings
‘‘Search’’ box and follow the prompts cell therapies, therapeutic tissue
engineering products, human cell and Between the FDA and Sponsors or
and/or go to the Dockets Management Applicants of PDUFA Products’’ have
Staff, 5630 Fishers Lane, Rm. 1061, tissue products, and combination
products using any such therapies or been approved under OMB control
Rockville, MD 20852. number 0910–0429; the collections of
You may submit comments on any products, except for those regulated
solely under section 361 of the Public information in 21 CFR part 601 have
guidance at any time (see 21 CFR been approved under OMB control
10.115(g)(5)). Health Service Act (PHS Act) (42 U.S.C.
264) and 21 CFR part 1271. Gene number 0910–0338; the collections of
Submit written requests for single information for expedited programs in
copies of the draft guidance to the Office therapies, including genetically
modified cells, that lead to a durable ‘‘Guidance for Industry: Expedited
of Communication, Outreach and Programs for Serious Conditions—Drugs
Development, Center for Biologics modification of cells or tissues can meet
the definition of a regenerative medicine and Biologics,’’ have been approved
Evaluation and Research (CBER), Food under OMB control number 0910–0765;
and Drug Administration, 10903 New therapy. Under section 506(g) of the
FD&C Act, RMAT designation is the collections of information in 21 CFR
Hampshire Ave., Bldg. 71, Rm. 3128, part 314 have been approved under
Silver Spring, MD 20993–0002. Send available for a drug (i.e., a human drug,
including a drug that is a biological OMB control number 0910–0001.
one self-addressed adhesive label to
assist the office in processing your product) that meets the definition of III. Electronic Access
requests. The draft guidance may also be regenerative medicine therapy; is
intended to treat, modify, reverse, or Persons with access to the Internet
obtained by mail by calling CBER at 1– may obtain the draft guidance at either
800–835–4709 or 240–402–8010. See cure a serious or life-threatening disease
or condition; and with respect to which https://www.fda.gov/
the SUPPLEMENTARY INFORMATION section BiologicsBloodVaccines/
for electronic access to the draft preliminary clinical evidence indicates
the potential to address unmet medical GuidanceCompliance
guidance document. RegulatoryInformation/Guidances/
needs for such disease or condition. A
FOR FURTHER INFORMATION CONTACT: default.htm or https://
combination product (biologic-device,
Tami Belouin, Center for Biologics biologic-drug, or biologic-device-drug) www.regulations.gov.
Evaluation and Research, Food and can be eligible for RMAT designation Dated: November 13, 2017.
Drug Administration, 10903 New when the biological product provides Anna K. Abram,
Hampshire Ave., Bldg. 71, Rm. 7301, the greatest contribution to the overall
Silver Spring, MD 20993–0002, 240– Deputy Commissioner for Policy, Planning,
intended therapeutic effects of the Legislation, and Analysis.
402–7911. combination product (i.e., the primary [FR Doc. 2017–24837 Filed 11–16–17; 8:45 am]
SUPPLEMENTARY INFORMATION: mode of action in the combination BILLING CODE 4164–01–P
I. Background product is conveyed by the biological
product component).
FDA is announcing the availability of Elsewhere in this issue of the Federal DEPARTMENT OF HEALTH AND
a draft document entitled ‘‘Expedited Register, FDA is announcing the HUMAN SERVICES
Programs for Regenerative Medicine availability of a document entitled
Therapies for Serious Conditions; Draft ‘‘Evaluation of Devices Used with Food and Drug Administration
Guidance for Industry.’’ The draft Regenerative Medicine Advanced
guidance document describes the Therapies; Draft Guidance for Industry.’’ [Docket No. FDA–2014–D–1167]
expedited programs available to This draft guidance is being issued
Controlled Correspondence Related to
sponsors of regenerative medicine consistent with FDA’s good guidance
Generic Drug Development; Draft
therapies for serious or life-threatening practices regulation (21 CFR 10.115).
Guidance for Industry; Availability;
diseases or conditions (referred to in the The draft guidance, when finalized, will
Correction
draft guidance as serious conditions), represent the current thinking of FDA
including those products designated as on ‘‘Expedited Programs for AGENCY: Food and Drug Administration,
RMATs; provides information about the Regenerative Medicine Therapies for HHS.
provisions in the 21st Century Cures Act Serious Conditions; Draft Guidance for
sradovich on DSK3GMQ082PROD with NOTICES
ACTION: Notice; correction.
(Cures Act) (Pub. L. 114–225) regarding Industry.’’ It does not establish any
the use of the accelerated approval rights for any person and is not binding SUMMARY: The Food and Drug
pathway for regenerative medicine on FDA or the public. You can use an Administration is correcting a notice
therapies that have been granted alternative approach if it satisfies the entitled ‘‘Controlled Correspondence
designation as an RMAT; describes how requirements of the applicable statutes Related to Generic Drug Development;
CBER will encourage flexibility in and regulations. This guidance is not Draft Guidance for Industry;
clinical trial design to facilitate the subject to Executive Order 12866. Availability’’ that appeared in the
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![Federal Register / Vol. 82, No. 221 / Friday, November 17, 2017 / Notices 54387
Federal Register of November 3, 2017. Comments submitted electronically, redacted/blacked out, will be available
The document announced the including attachments, to https://www. for public viewing and posted on
availability of a draft guidance for regulations.gov will be posted to the https://www.regulations.gov. Submit
industry. The document was published docket unchanged. Because your both copies to the Dockets Management
with the incorrect docket number. This comment will be made public, you are Staff. If you do not wish your name and
document corrects that error. solely responsible for ensuring that your contact information to be made publicly
FOR FURTHER INFORMATION CONTACT: Lisa comment does not include any available, you can provide this
Granger, Office of Policy, Food and Drug confidential information that you or a information on the cover sheet and not
Administration, 10903 New Hampshire third party may not wish to be posted, in the body of your comments and you
Ave. Bldg. 32, Rm. 3330, Silver Spring, such as medical information, your or must identify this information as
MD 20993–0002, 301–796–9115, anyone else’s Social Security number, or ‘‘confidential.’’ Any information marked
lisa.granger@fda.hhs.gov. confidential business information, such as ‘‘confidential’’ will not be disclosed
SUPPLEMENTARY INFORMATION: In the
as a manufacturing process. Please note except in accordance with 21 CFR 10.20
Federal Register of Friday, November 3, that if you include your name, contact and other applicable disclosure law. For
2017 (82 FR 51277), in FR Doc. 2017– information, or other information that more information about FDA’s posting
23947, the following correction is made: identifies you in the body of your of comments to public dockets, see 80
On page 51277, in the second column, comments, that information will be FR 56469, September 18, 2015, or access
in the header of the document, ‘‘[Docket posted on https://www.regulations.gov. the information at: https://www.gpo.gov/
FDA–2014–D–1147]’’ is corrected to • If you want to submit a comment fdsys/pkg/FR-2015-09-18/pdf/2015-
read ‘‘[Docket No. FDA–2014–D–1167]’’. with confidential information that you 23389.pdf.
do not wish to be made available to the
Dated: November 9, 2017. public, submit the comment as a Docket: For access to the docket to
Anna K. Abram, written/paper submission and in the read background documents or the
Deputy Commissioner for Policy, Planning, manner detailed (see ‘‘Written/Paper electronic and written/paper comments
Legislation, and Analysis. Submissions’’ and ‘‘Instructions’’). received, go to https://www.regulations.
[FR Doc. 2017–24948 Filed 11–16–17; 8:45 am]
gov and insert the docket number, found
Written/Paper Submissions in brackets in the heading of this
BILLING CODE 4164–01–P
Submit written/paper submissions as document, into the ‘‘Search’’ box and
follows: follow the prompts and/or go to the
DEPARTMENT OF HEALTH AND • Mail/Hand delivery/Courier (for Dockets Management Staff, 5630 Fishers
HUMAN SERVICES written/paper submissions): Dockets Lane, Rm. 1061, Rockville, MD 20852.
Management Staff (HFA–305), Food and You may submit comments on any
Food and Drug Administration Drug Administration, 5630 Fishers guidance at any time (see 21 CFR
[Docket No. FDA–2015–D–2245]
Lane, Rm. 1061, Rockville, MD 20852. 10.115(g)(5)).
• For written/paper comments
submitted to the Dockets Management An electronic copy of the guidance
Unique Device Identification: Direct document is available for download
Marking of Devices; Guidance for Staff, FDA will post your comment, as
well as any attachments, except for from the internet. See the
Industry and Food and Drug SUPPLEMENTARY INFORMATION section for
Administration Staff; Availability information submitted, marked and
identified, as confidential, if submitted information on electronic access to the
AGENCY: Food and Drug Administration, as detailed in ‘‘Instructions.’’ guidance. Submit written requests for a
HHS. Instructions: All submissions received single hard copy of the guidance
ACTION: Notice of availability. must include the Docket No. FDA– document entitled ‘‘Unique Device
2015–D–2245 for ‘‘Unique Device Identification: Direct Marking of
SUMMARY: The Food and Drug Identification: Direct Marking of Devices’’ to the Office of the Center
Administration (FDA or Agency) is Devices.’’ Received comments will be Director, Guidance and Policy
announcing the availability of the placed in the docket and, except for Development, Center for Devices and
guidance entitled ‘‘Unique Device those submitted as ‘‘Confidential Radiological Health, Food and Drug
Identification: Direct Marking of Submissions,’’ publicly viewable at Administration, 10903 New Hampshire
Devices.’’ This document is intended to https://www.regulations.gov or at the Ave., Bldg. 66, Rm. 5431, Silver Spring,
clarify when direct marking of devices Dockets Management Staff between 9 MD 20993–0002, or the Office of
with a unique device identifier (UDI) is a.m. and 4 p.m., Monday through Communication, Outreach, and
required, and to assist industry and FDA Friday. Development, Center for Biologics
staff in understanding direct marking • Confidential Submissions—To Evaluation and Research, Food and
requirements. submit a comment with confidential Drug Administration, 10903 New
DATES: The announcement of the information that you do not wish to be Hampshire Ave., Bldg. 71, Rm. 3128,
guidance is published in the Federal made publicly available, submit your Silver Spring, MD 20993–0002. Send
Register on November 17, 2017. comments only as a written/paper one self-addressed adhesive label to
submission. You should submit two assist that office in processing your
ADDRESSES: You may submit either
copies total. One copy will include the request.
electronic or written comments on
Agency guidances at any time as information you claim to be confidential
FOR FURTHER INFORMATION CONTACT:
with a heading or cover note that states
sradovich on DSK3GMQ082PROD with NOTICES
follows: Christina Savisaar, Center for Devices
‘‘THIS DOCUMENT CONTAINS
Electronic Submissions and Radiological Health, Food and Drug
CONFIDENTIAL INFORMATION.’’ The
Administration, 10903 New Hampshire
Submit electronic comments in the Agency will review this copy, including
Ave., Bldg. 66, Rm. 3303, Silver Spring,
following way: the claimed confidential information, in
MD 20993–0002, 301–496–6404, email:
• Federal eRulemaking Portal: its consideration of comments. The
GUDIDSupport@fda.hhs.gov.
https://www.regulations.gov. Follow the second copy, which will have the
instructions for submitting comments. claimed confidential information SUPPLEMENTARY INFORMATION:
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Document Created: 2017-11-17 05:14:43
Document Modified: 2017-11-17 05:14:43
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice; correction. | |
| 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, [email protected] | |
| FR Citation | 82 FR 54386 |
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