80_FR_62020 80 FR 61822 - Recommendations for Microbial Vectors Used for Gene Therapy; Draft Guidance for Industry; Availability

80 FR 61822 - Recommendations for Microbial Vectors Used for Gene Therapy; Draft Guidance for Industry; Availability

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 80, Issue 198 (October 14, 2015)

Page Range61822-61824
FR Document2015-26108

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft document entitled ``Recommendations for Microbial Vectors Used for Gene Therapy; Draft Guidance for Industry.'' The draft guidance provides investigational new drug application (IND) sponsors, with recommendations concerning IND submissions for microbial vectors used for gene therapy (MVGTs) in early-phase clinical trials. MVGTs meet the regulatory definition of ``biological product'', when such products are applicable to the prevention, treatment, or cure of a disease or condition of human beings. The draft guidance focuses on the chemistry, manufacturing, and control (CMC) information that sponsors should submit in an IND for MVGTs and provides an overview of preclinical and clinical considerations for these products. The draft guidance, when finalized, will supplement the guidance entitled, ``Guidance for FDA Reviewers and Sponsors: Content and Review of Chemistry, Manufacturing, and Control (CMC) Information for Human Gene Therapy Investigational New Drug Applications (INDs),'' dated April 2008 (April 2008 Guidance).

Federal Register, Volume 80 Issue 198 (Wednesday, October 14, 2015)
[Federal Register Volume 80, Number 198 (Wednesday, October 14, 2015)]
[Notices]
[Pages 61822-61824]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-26108]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-D-3399]


Recommendations for Microbial Vectors Used for Gene Therapy; 
Draft Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
the availability of a draft document entitled ``Recommendations for 
Microbial Vectors Used for Gene Therapy; Draft Guidance for Industry.'' 
The draft guidance provides investigational new drug application (IND) 
sponsors, with recommendations concerning IND submissions for microbial 
vectors used for gene therapy (MVGTs) in early-phase clinical trials. 
MVGTs meet the regulatory definition of

[[Page 61823]]

``biological product'', when such products are applicable to the 
prevention, treatment, or cure of a disease or condition of human 
beings. The draft guidance focuses on the chemistry, manufacturing, and 
control (CMC) information that sponsors should submit in an IND for 
MVGTs and provides an overview of preclinical and clinical 
considerations for these products. The draft guidance, when finalized, 
will supplement the guidance entitled, ``Guidance for FDA Reviewers and 
Sponsors: Content and Review of Chemistry, Manufacturing, and Control 
(CMC) Information for Human Gene Therapy Investigational New Drug 
Applications (INDs),'' dated April 2008 (April 2008 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 December 14, 2015.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to http://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 http://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): Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of 
Dockets Management, 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-3399 for ``Recommendations for Microbial Vectors Used for 
Gene Therapy; Draft Guidance for Industry.'' Received comments will be 
placed in the docket and, except for those submitted as ``Confidential 
Submissions'' publicly viewable at http://www.regulations.gov or at the 
Division of Dockets Management 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 redacted/blacked out, will be 
available for public viewing and posted on http://www.regulations.gov. 
Submit both copies to the Division of Dockets Management. 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: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to http://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 Division of Dockets Management, 5630 Fishers 
Lane, Rm. 1061, Rockville, MD 20852.
    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: Paul E. Levine, Jr., 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 draft document entitled, 
``Recommendations for Microbial Vectors Used for Gene Therapy; Draft 
Guidance for Industry.'' The draft guidance provides IND sponsors, with 
recommendations concerning IND submissions for MVGTs in early-phase 
clinical trials. MVGTs meet the definition of ``biological product'' in 
section 351(i) of the Public Health Service Act (42 U.S.C. 262), when 
such products are applicable to the prevention, treatment, or cure of a 
disease or condition of human beings. MVGTs include bacterial vectors 
such as Salmonella, Listeria, or E. coli genetically modified to 
express human tumor antigens, cytokines, growth factors, enzymes, 
therapeutic proteins, or nucleotides. MVGTs may also be generated by 
the modification (deletion, truncation, or point mutation) of 
chromosomal or episomal genes and by the insertion of foreign genetic 
material into the chromosome, or into naturally occurring episomes; or 
by the introduction of one or more plasmids. The MVGTs may consist of 
microbes that are either live, replication restricted (division under 
specific growth conditions), capable of limited or no cell divisions, 
or killed, or a combination of these forms. The guidance focuses on the 
CMC information that sponsors should submit in an IND for MVGTs and 
provides an overview of preclinical and clinical considerations for 
these products.

[[Page 61824]]

    In the Federal Register of April 10, 2008 (73 FR 19511), FDA 
announced the availability of the April 2008 Guidance. In that 
guidance, FDA provided sponsors of a human gene therapy IND, including 
those with combination products that contain a human gene therapy 
biological product with a drug or device as part of the final product, 
with recommendations on CMC information that is to be included in an 
original IND. That guidance also provided instruction to FDA CMC 
reviewers about the information to record and assess as part of an IND 
review. The draft guidance, when finalized, will supplement the April 
2008 Guidance.
    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 recommendations for 
MVGTs. It does not establish 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 parts 211, 610, and 312 have been 
approved under OMB control numbers 0910-0139 and 0910-0114, 
respectively.

III. Electronic Access

    Persons with access to the Internet may obtain the draft guidance 
at either http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or http://www.regulations.gov.

    Dated: October 7, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-26108 Filed 10-13-15; 8:45 am]
BILLING CODE 4164-01-P



                                              61822                     Federal Register / Vol. 80, No. 198 / Wednesday, October 14, 2015 / Notices

                                                Dated: October 7, 2015.                               do not wish to be made available to the               regulatoryinformation/dockets/
                                              Leslie Kux,                                             public, submit the comment as a                       default.htm.
                                              Associate Commissioner for Policy.                      written/paper submission and in the                      Docket: For access to the docket to
                                              [FR Doc. 2015–26055 Filed 10–13–15; 8:45 am]            manner detailed (see ‘‘Written/Paper                  read background documents or the
                                              BILLING CODE 4164–01–P                                  Submissions’’ and ‘‘Instructions’’).                  electronic and written/paper comments
                                                                                                                                                            received, go to http://
                                                                                                      Written/Paper Submissions
                                                                                                                                                            www.regulations.gov and insert the
                                              DEPARTMENT OF HEALTH AND                                   Submit written/paper submissions as                docket number, found in brackets in the
                                              HUMAN SERVICES                                          follows:                                              heading of this document, into the
                                                                                                         • Mail/Hand delivery/Courier (for                  ‘‘Search’’ box and follow the prompts
                                              Food and Drug Administration                            written/paper submissions): Division of               and/or go to the Division of Dockets
                                                                                                      Dockets Management (HFA–305), Food                    Management, 5630 Fishers Lane, Rm.
                                              [Docket No. FDA–2010–N–0128]                            and Drug Administration, 5630 Fishers                 1061, Rockville, MD 20852.
                                              Prescription Drug User Fee Act;                         Lane, Rm. 1061, Rockville, MD 20852.
                                                                                                                                                            FOR FURTHER INFORMATION CONTACT:
                                                                                                         • For written/paper comments
                                              Reopening of Comment Period                                                                                   Graham Thompson, Center for Drug
                                                                                                      submitted to the Division of Dockets
                                                                                                      Management, FDA will post your                        Evaluation and Research, Food and
                                              AGENCY:    Food and Drug Administration,
                                              HHS.                                                    comment, as well as any attachments,                  Drug Administration, 10903 New
                                                                                                      except for information submitted,                     Hampshire Ave., Bldg. 51, Rm. 1146,
                                              ACTION:   Notice; reopening of comment                                                                        Silver Spring, MD 20993–0002, 301–
                                              period.                                                 marked and identified, as confidential,
                                                                                                      if submitted as detailed in                           796–5003.
                                              SUMMARY:   The Food and Drug                            ‘‘Instructions.’’                                     SUPPLEMENTARY INFORMATION: In the
                                              Administration (FDA) is reopening until                    Instructions: All submissions received             Federal Register of May 13, 2015, FDA
                                              April 29, 2016, the comment period for                  must include the Docket No. FDA–                      published a notice of public meeting
                                              the notice of public meeting that                       2010–N–0128 for ‘‘Prescription Drug                   with a 30-day comment period
                                              appeared in the Federal Register of May                 User Fee Act; Reopening of Comment                    following the public meeting and
                                              13, 2015 (80 FR 27323). In the notice of                Period.’’ Received comments will be                   invited comments as the Agency began
                                              public meeting, FDA invited public                      placed in the docket and, except for                  the process to reauthorize PDUFA in
                                              comment as the Agency begins the                        those submitted as ‘‘Confidential                     FYs 2018 to 2022.
                                              process to reauthorize the Prescription                 Submissions,’’ publicly viewable at                      FDA is reopening the comment period
                                              Drug User Fee Act (PDUFA) in fiscal                     http://www.regulations.gov or at the                  until April 29, 2016. The Agency
                                              years (FYs) 2018 to 2022. The Agency is                 Division of Dockets Management                        believes that reopening the comment
                                              taking this action to allow interested                  between 9 a.m. and 4 p.m., Monday                     period for the notice of public meeting
                                              persons additional time to submit                       through Friday.                                       will allow adequate time for interested
                                              comments.                                                  • Confidential Submissions—To                      persons to submit comments.
                                              DATES: FDA is reopening the comment                     submit a comment with confidential                      Dated: October 7, 2015.
                                              period on the notice of public meeting                  information that you do not wish to be                Leslie Kux,
                                              published May 13, 2015 (80 FR 27323).                   made publicly available, submit your
                                                                                                                                                            Associate Commissioner for Policy.
                                              Submit either electronic or written                     comments only as a written/paper
                                                                                                                                                            [FR Doc. 2015–26052 Filed 10–13–15; 8:45 am]
                                              comments by April 29, 2016.                             submission. You should submit two
                                                                                                      copies total. One copy will include the               BILLING CODE 4164–01–P
                                              ADDRESSES: You may submit comments
                                              as follows:                                             information you claim to be confidential
                                                                                                      with a heading or cover note that states
                                              Electronic Submissions                                  ‘‘THIS DOCUMENT CONTAINS                              DEPARTMENT OF HEALTH AND
                                                                                                      CONFIDENTIAL INFORMATION’’. The                       HUMAN SERVICES
                                                Submit electronic comments in the
                                              following way:                                          Agency will review this copy, including               Food and Drug Administration
                                                • Federal eRulemaking Portal: http://                 the claimed confidential information, in
                                              www.regulations.gov. Follow the                         its consideration of comments. The                    [Docket No. FDA–2015–D–3399]
                                              instructions for submitting comments.                   second copy, which will have the
                                                                                                      claimed confidential information                      Recommendations for Microbial
                                              Comments submitted electronically,
                                                                                                      redacted/blacked out, will be available               Vectors Used for Gene Therapy; Draft
                                              including attachments, to http://
                                                                                                      for public viewing and posted on http://              Guidance for Industry; Availability
                                              www.regulations.gov will be posted to
                                              the docket unchanged. Because your                      www.regulations.gov. Submit both                      AGENCY:    Food and Drug Administration,
                                              comment will be made public, you are                    copies to the Division of Dockets                     HHS.
                                              solely responsible for ensuring that your               Management. If you do not wish your                   ACTION:   Notice.
                                              comment does not include any                            name and contact information to be
                                              confidential information that you or a                  made publicly available, you can                      SUMMARY:   The Food and Drug
                                              third party may not wish to be posted,                  provide this information on the cover                 Administration (FDA or Agency) is
                                              such as medical information, your or                    sheet and not in the body of your                     announcing the availability of a draft
                                              anyone else’s Social Security number, or                comments and you must identify this                   document entitled ‘‘Recommendations
                                              confidential business information, such                 information as ‘‘confidential.’’ Any                  for Microbial Vectors Used for Gene
                                              as a manufacturing process. Please note                 information marked as ‘‘confidential’’                Therapy; Draft Guidance for Industry.’’
tkelley on DSK3SPTVN1PROD with NOTICES




                                              that if you include your name, contact                  will not be disclosed except in                       The draft guidance provides
                                              information, or other information that                  accordance with 21 CFR 10.20 and other                investigational new drug application
                                              identifies you in the body of your                      applicable disclosure law. For more                   (IND) sponsors, with recommendations
                                              comments, that information will be                      information about FDA’s posting of                    concerning IND submissions for
                                              posted on http://www.regulations.gov.                   comments to public dockets, see 80 FR                 microbial vectors used for gene therapy
                                                • If you want to submit a comment                     56469, September 18, 2015, or access                  (MVGTs) in early-phase clinical trials.
                                              with confidential information that you                  the information at: http://www.fda.gov/               MVGTs meet the regulatory definition of


                                         VerDate Sep<11>2014   16:39 Oct 13, 2015   Jkt 238001   PO 00000   Frm 00033   Fmt 4703   Sfmt 4703   E:\FR\FM\14OCN1.SGM   14OCN1


                                                                        Federal Register / Vol. 80, No. 198 / Wednesday, October 14, 2015 / Notices                                             61823

                                              ‘‘biological product’’, when such                       Dockets Management (HFA–305), Food                    and/or go to the Division of Dockets
                                              products are applicable to the                          and Drug Administration, 5630 Fishers                 Management, 5630 Fishers Lane, Rm.
                                              prevention, treatment, or cure of a                     Lane, rm. 1061, Rockville, MD 20852.                  1061, Rockville, MD 20852.
                                              disease or condition of human beings.                      • For written/paper comments                         Submit written requests for single
                                              The draft guidance focuses on the                       submitted to the Division of Dockets                  copies of the draft guidance to the Office
                                              chemistry, manufacturing, and control                   Management, FDA will post your                        of Communication, Outreach and
                                              (CMC) information that sponsors should                  comment, as well as any attachments,                  Development, Center for Biologics
                                              submit in an IND for MVGTs and                          except for information submitted,                     Evaluation and Research (CBER), Food
                                              provides an overview of preclinical and                 marked and identified, as confidential,               and Drug Administration, 10903 New
                                              clinical considerations for these                       if submitted as detailed in                           Hampshire Ave., Bldg. 71, Rm. 3128,
                                              products. The draft guidance, when                      ‘‘Instructions.’’                                     Silver Spring, MD 20993–0002. Send
                                              finalized, will supplement the guidance                    Instructions: All submissions received             one self-addressed adhesive label to
                                              entitled, ‘‘Guidance for FDA Reviewers                  must include the Docket No. FDA–                      assist the office in processing your
                                              and Sponsors: Content and Review of                     2015–D–3399 for ‘‘Recommendations                     requests. The draft guidance may also be
                                              Chemistry, Manufacturing, and Control                   for Microbial Vectors Used for Gene                   obtained by mail by calling CBER at 1–
                                              (CMC) Information for Human Gene                        Therapy; Draft Guidance for Industry.’’               800–835–4709 or 240–402–8010. See
                                              Therapy Investigational New Drug                        Received comments will be placed in                   the SUPPLEMENTARY INFORMATION section
                                              Applications (INDs),’’ dated April 2008                 the docket and, except for those                      for electronic access to the draft
                                              (April 2008 Guidance).                                  submitted as ‘‘Confidential                           guidance document.
                                                                                                      Submissions’’ publicly viewable at
                                              DATES: Although you can comment on                                                                            FOR FURTHER INFORMATION CONTACT: Paul
                                                                                                      http://www.regulations.gov or at the
                                              any guidance at any time (see 21 CFR                                                                          E. Levine, Jr., Center for Biologics
                                                                                                      Division of Dockets Management
                                              10.115(g)(5)), to ensure that the Agency                                                                      Evaluation and Research, Food and
                                                                                                      between 9 a.m. and 4 p.m., Monday
                                              considers your comment on this draft                                                                          Drug Administration, 10903 New
                                                                                                      through Friday.
                                              guidance before it begins work on the                      • Confidential Submissions—To                      Hampshire Ave., Bldg. 71, rm. 7301,
                                              final version of the guidance, submit                   submit a comment with confidential                    Silver Spring, MD 20993–0002, 240–
                                              either electronic or written comments                   information that you do not wish to be                402–7911.
                                              on the draft guidance by December 14,                   made publicly available, submit your                  SUPPLEMENTARY INFORMATION:
                                              2015.                                                   comments only as a written/paper                      I. Background
                                              ADDRESSES: You may submit comments                      submission. You should submit two
                                              as follows:                                             copies total. One copy will include the                  FDA is announcing the availability of
                                                                                                      information you claim to be confidential              a draft document entitled,
                                              Electronic Submissions                                                                                        ‘‘Recommendations for Microbial
                                                                                                      with a heading or cover note that states
                                                Submit electronic comments in the                     ‘‘THIS DOCUMENT CONTAINS                              Vectors Used for Gene Therapy; Draft
                                              following way:                                          CONFIDENTIAL INFORMATION’’. The                       Guidance for Industry.’’ The draft
                                                • Federal eRulemaking Portal: http://                 Agency will review this copy, including               guidance provides IND sponsors, with
                                              www.regulations.gov. Follow the                         the claimed confidential information, in              recommendations concerning IND
                                              instructions for submitting comments.                   its consideration of comments. The                    submissions for MVGTs in early-phase
                                              Comments submitted electronically,                      second copy, which will have the                      clinical trials. MVGTs meet the
                                              including attachments, to http://                       claimed confidential information                      definition of ‘‘biological product’’ in
                                              www.regulations.gov will be posted to                   redacted/blacked out, will be available               section 351(i) of the Public Health
                                              the docket unchanged. Because your                      for public viewing and posted on http://              Service Act (42 U.S.C. 262), when such
                                              comment will be made public, you are                    www.regulations.gov. Submit both                      products are applicable to the
                                              solely responsible for ensuring that your               copies to the Division of Dockets                     prevention, treatment, or cure of a
                                              comment does not include any                            Management. If you do not wish your                   disease or condition of human beings.
                                              confidential information that you or a                  name and contact information to be                    MVGTs include bacterial vectors such
                                              third party may not wish to be posted,                  made publicly available, you can                      as Salmonella, Listeria, or E. coli
                                              such as medical information, your or                    provide this information on the cover                 genetically modified to express human
                                              anyone else’s Social Security number, or                sheet and not in the body of your                     tumor antigens, cytokines, growth
                                              confidential business information, such                 comments and you must identify this                   factors, enzymes, therapeutic proteins,
                                              as a manufacturing process. Please note                 information as ‘‘confidential.’’ Any                  or nucleotides. MVGTs may also be
                                              that if you include your name, contact                  information marked as ‘‘confidential’’                generated by the modification (deletion,
                                              information, or other information that                  will not be disclosed except in                       truncation, or point mutation) of
                                              identifies you in the body of your                      accordance with 21 CFR 10.20 and other                chromosomal or episomal genes and by
                                              comments, that information will be                      applicable disclosure law. For more                   the insertion of foreign genetic material
                                              posted on http://www.regulations.gov.                   information about FDA’s posting of                    into the chromosome, or into naturally
                                                • If you want to submit a comment                     comments to public dockets, see 80 FR                 occurring episomes; or by the
                                              with confidential information that you                  56469, September 18, 2015, or access                  introduction of one or more plasmids.
                                              do not wish to be made available to the                 the information at: http://www.fda.gov/               The MVGTs may consist of microbes
                                              public, submit the comment as a                         regulatoryinformation/dockets/                        that are either live, replication restricted
                                              written/paper submission and in the                     default.htm.                                          (division under specific growth
                                              manner detailed (see ‘‘Written/Paper                       Docket: For access to the docket to                conditions), capable of limited or no cell
tkelley on DSK3SPTVN1PROD with NOTICES




                                              Submissions’’ and ‘‘Instructions’’).                    read background documents or the                      divisions, or killed, or a combination of
                                                                                                      electronic and written/paper comments                 these forms. The guidance focuses on
                                              Written/Paper Submissions                               received, go to http://                               the CMC information that sponsors
                                                Submit written/paper submissions as                   www.regulations.gov and insert the                    should submit in an IND for MVGTs and
                                              follows:                                                docket number, found in brackets in the               provides an overview of preclinical and
                                                • Mail/Hand delivery/Courier (for                     heading of this document, into the                    clinical considerations for these
                                              written/paper submissions): Division of                 ‘‘Search’’ box and follow the prompts                 products.


                                         VerDate Sep<11>2014   16:39 Oct 13, 2015   Jkt 238001   PO 00000   Frm 00034   Fmt 4703   Sfmt 4703   E:\FR\FM\14OCN1.SGM   14OCN1


                                              61824                     Federal Register / Vol. 80, No. 198 / Wednesday, October 14, 2015 / Notices

                                                 In the Federal Register of April 10,                 DEPARTMENT OF HEALTH AND                              will have the opportunity to provide
                                              2008 (73 FR 19511), FDA announced the                   HUMAN SERVICES                                        comments. Interested parties should
                                              availability of the April 2008 Guidance.                                                                      refer to the meeting subject as the HRSA
                                              In that guidance, FDA provided                          Health Resources and Service                          Council on Graduate Medical
                                              sponsors of a human gene therapy IND,                   Administration                                        Education.
                                              including those with combination                                                                                • The conference call-in number is 1–
                                                                                                      Advisory Committee on Training in                     800–619–2521. The passcode is:
                                              products that contain a human gene
                                                                                                      Primary Care Medicine and Dentistry;                  9271697.
                                              therapy biological product with a drug                  Notice of Meeting                                       • The webinar link is https://
                                              or device as part of the final product,
                                                                                                         In accordance with section 10(a)(2) of             hrsa.connectsolutions.com/
                                              with recommendations on CMC
                                                                                                      the Federal Advisory Committee Act                    cogme-2015/.
                                              information that is to be included in an                                                                        Contact: Anyone requesting
                                              original IND. That guidance also                        (Public Law 92–463), notice is hereby
                                                                                                                                                            information regarding the COGME
                                              provided instruction to FDA CMC                         given of the following meeting:
                                                                                                         Name: Council on Graduate Medical                  should contact Dr. Joan Weiss,
                                              reviewers about the information to                                                                            Designated Federal Official within the
                                              record and assess as part of an IND                     Education (COGME).
                                                                                                         Dates and Times: October 29, 2015                  Bureau of Health Workforce, Health
                                              review. The draft guidance, when                                                                              Resources and Services Administration,
                                                                                                      (10:30 a.m.–4:30 p.m.).
                                              finalized, will supplement the April                                                                          in one of three ways: (1) Send a request
                                                                                                         Place: Conference Call/Webinar
                                              2008 Guidance.                                                                                                to the following address: Dr. Joan Weiss,
                                                                                                      Format.
                                                 The draft guidance is being issued                      Status: The meeting will be open to                Designated Federal Official, Bureau of
                                              consistent with FDA’s good guidance                     the public.                                           Health Workforce, Health Resources and
                                              practices regulation (21 CFR 10.115).                      Purpose: The COGME provides advice                 Services Administration, Parklawn
                                              The draft guidance, when finalized, will                and recommendations to the Secretary                  Building, Room 12C–05, 5600 Fishers
                                              represent FDA’s current thinking on                     of the Department of Health and Human                 Lane, Rockville, Maryland 20857; (2)
                                              recommendations for MVGTs. It does                      Services (the Secretary) on a range of                call (301) 443–0430; or (3) send an email
                                                                                                      issues including the supply and                       to jweiss@hrsa.gov.
                                              not establish any rights for or on any
                                              person and does not operate to bind                     distribution of physicians in the United              Jackie Painter,
                                              FDA or the public. An alternative                       States, current and future physician                  Director, Division of the Executive Secretariat.
                                              approach may be used if such approach                   shortages or excesses, issues relating to             [FR Doc. 2015–26053 Filed 10–13–15; 8:45 am]
                                              satisfies the requirement of the                        foreign medical school graduates, the
                                                                                                                                                            BILLING CODE 4165–15–P
                                              applicable statutes and regulations.                    nature and financing of medical
                                                                                                      education training, and the
                                              II. Paperwork Reduction Act of 1995                     development of performance measures                   DEPARTMENT OF HEALTH AND
                                                                                                      and longitudinal evaluation of medical                HUMAN SERVICES
                                                The draft guidance refers to                          education programs. COGME’s reports
                                              previously approved collections of                      are submitted to the Secretary and                    Office of the Secretary
                                              information found in FDA regulations.                   ranking members of the Senate
                                              These collections of information are                                                                          [Document Identifier: HHS–OS–0990–New–
                                                                                                      Committee on Health, Education, Labor,
                                              subject to review by the Office of                                                                            30D]
                                                                                                      and Pensions and the House of
                                              Management and Budget (OMB) under                       Representatives Committee on Energy                   Agency Information Collection
                                              the Paperwork Reduction Act of 1995                     and Commerce.                                         Activities; Submission to OMB for
                                              (44 U.S.C. 3501–3520). The collections                     HRSA will conduct an orientation for               Review and Approval; Public Comment
                                              of information in 21 CFR parts 211, 610,                new members prior to the start of the                 Request
                                              and 312 have been approved under                        meeting. COGME will start its official
                                              OMB control numbers 0910–0139 and                       meeting at 10:30 a.m. After the                       AGENCY:   Office of the Secretary, HHS.
                                              0910–0114, respectively.                                orientation, discussion will focus on                 ACTION:   Notice.
                                                                                                      one of the recommendations from the
                                              III. Electronic Access                                  March 2015 meeting, namely, to identify               SUMMARY:   In compliance with section
                                                                                                      actions COGME can take within its                     3507(a)(1)(D) of the Paperwork
                                                Persons with access to the Internet                                                                         Reduction Act of 1995, the Office of the
                                                                                                      current authorities to achieve the
                                              may obtain the draft guidance at either                                                                       Secretary (OS), Department of Health
                                                                                                      development of a National Strategic
                                              http://www.fda.gov/                                                                                           and Human Services, has submitted an
                                                                                                      Plan for Graduate Medical Education.
                                              BiologicsBloodVaccines/                                    Agenda: The COGME agenda will be                   Information Collection Request (ICR),
                                              GuidanceCompliance                                      available 2 days prior to the meeting on              described below, to the Office of
                                              RegulatoryInformation/Guidances/                        the HRSA Web site at http://                          Management and Budget (OMB) for
                                              default.htm or http://                                  www.hrsa.gov/advisorycommittees/                      review and approval. The ICR is for a
                                              www.regulations.gov.                                    bhpradvisory/cogme/index.html.                        new collection. Comments submitted
                                                                                                                                                            during the first public review of this ICR
                                                Dated: October 7, 2015.                               SUPPLEMENTARY INFORMATION: Requests
                                                                                                                                                            will be provided to OMB. OMB will
                                              Leslie Kux,                                             to make oral comments or provide
                                                                                                                                                            accept further comments from the
                                              Associate Commissioner for Policy.                      written comments to the COGME should
                                                                                                                                                            public on this ICR during the review
                                                                                                      be sent to Dr. Joan Weiss, Designated
                                              [FR Doc. 2015–26108 Filed 10–13–15; 8:45 am]                                                                  and approval period.
tkelley on DSK3SPTVN1PROD with NOTICES




                                                                                                      Federal Official, using the address and
                                              BILLING CODE 4164–01–P
                                                                                                      phone number below. Individuals who                   DATES: Comments on the ICR must be
                                                                                                      plan to participate on the conference                 received on or before November 13,
                                                                                                      call and webinar should notify Dr.                    2015.
                                                                                                      Weiss at least 3 days prior to the                    ADDRESSES: Submit your comments to
                                                                                                      meeting, using the address and phone                  OIRA_submission@omb.eop.gov or via
                                                                                                      number below. Members of the public                   facsimile to (202) 395–5806.


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Document Created: 2018-02-27 08:49:58
Document Modified: 2018-02-27 08:49:58
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice.
DatesAlthough 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 December 14, 2015.
ContactPaul E. Levine, Jr., 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.
FR Citation80 FR 61822 

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