80 FR 15617 - Determining the Need for and Content of Environmental Assessments for Gene Therapies, Vectored Vaccines, and Related Recombinant Viral or Microbial Products; Guidance for Industry: Availability
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 80, Issue 56 (March 24, 2015)
Food and Drug Administration
Federal Register Volume 80, Issue 56 (March 24, 2015)
| Page Range | 15617-15617 | |
| FR Document | 2015-06686 |
[Federal Register Volume 80, Number 56 (Tuesday, March 24, 2015)] [Notices] [Page 15617] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-06686] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2014-D-0663] Determining the Need for and Content of Environmental Assessments for Gene Therapies, Vectored Vaccines, and Related Recombinant Viral or Microbial Products; Guidance for Industry: Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of a document entitled ``Determining the Need for and Content of Environmental Assessments for Gene Therapies, Vectored Vaccines, and Related Recombinant Viral or Microbial Products; Guidance for Industry'' dated March 2015. The guidance document provides investigational new drug application (IND) sponsors and applicants for a biologics license application (BLA) or a supplement to a BLA (BLA supplement), with recommendations on considerations when assessing whether to submit an Environmental Assessment (EA) for gene therapies, vectored vaccines, and related recombinant viral or microbial products (GTVVs). The guidance also contains recommendations as to what information should be included in an EA and what you can expect once an EA is filed. The guidance announced in this notice finalizes the draft guidance of the same title dated June 2014. DATES: Submit either electronic or written comments on Agency guidances at any time. ADDRESSES: Submit written requests for single copies of the 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 guidance may also be obtained by mail by calling CBER at 1-800-835-4709 or 240-402-7800. See the SUPPLEMENTARY INFORMATION section for electronic access to the guidance document. Submit electronic comments on the guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. 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: I. Background FDA is announcing the availability of a document entitled ``Determining the Need for and Content of Environmental Assessments for Gene Therapies, Vectored Vaccines, and Related Recombinant Viral or Microbial Products; Guidance for Industry'' dated March 2015. The guidance document provides IND sponsors and applicants for a BLA or a BLA supplement, with recommendations on considerations when assessing whether to submit an EA for GTVVs. The guidance also contains recommendations as to what information should be included in an EA and what you can expect once an EA is filed. The guidance supplements the guidance entitled ``Guidance for Industry: Environmental Assessment of Human Drug and Biologics Applications'' dated July 1998 (July 27, 1998, 63 FR 40127) (1998 Guidance) and supersedes the recommendations for GTVVs in section IV.B.1 ``Assessing Toxicity to Environmental Organisms'' in the 1998 Guidance. The guidance announced in this notice finalizes the draft guidance of the same title dated June 2014. In the Federal Register of June 20, 2014 (79 FR 35361), FDA announced the availability of the draft guidance of the same title dated June 2014. FDA received a few comments on the draft guidance and those comments were considered as the guidance was finalized. There were no changes to the guidance except for one correction to a technical error regarding influenza taxonomy. The guidance announced in this notice finalizes the draft guidance dated June 2014. The guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The guidance represents 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 requirements of the applicable statutes and regulations. II. Paperwork Reduction Act of 1995 This 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 25 have been approved under OMB control number 0910-0322; the collections of information in 21 CFR part 312 have been approved under OMB control number 0910-0014; and the collections of information for 21 CFR part 601 have been approved under OMB control number 0910-0338. III. Comments Interested persons may submit either electronic comments regarding this document to http://www.regulations.gov or written comments to the Division of Dockets Management (see ADDRESSES). It is only necessary to send one set of comments. Identify comments with the docket number found in brackets in the heading of this document. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday, and will be posted to the docket at http://www.regulations.gov. IV. Electronic Access Persons with access to the Internet may obtain the guidance at either http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or http://www.regulations.gov. Dated: March 19, 2015. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2015-06686 Filed 3-23-15; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 80, No. 56 / Tuesday, March 24, 2015 / Notices 15617
Dated: March 18, 2015. for electronic access to the guidance public. An alternative approach may be
Michelle Trout, document. used if such approach satisfies the
Program Analyst, Office of Federal Advisory Submit electronic comments on the requirements of the applicable statutes
Committee Policy. guidance to http://www.regulations.gov. and regulations.
[FR Doc. 2015–06601 Filed 3–23–15; 8:45 am] Submit written comments to the
II. Paperwork Reduction Act of 1995
BILLING CODE 4140–01–P Division of Dockets Management (HFA–
305), Food and Drug Administration, This guidance refers to previously
5630 Fishers Lane, Rm. 1061, Rockville, approved collections of information
DEPARTMENT OF HEALTH AND MD 20852. found in FDA regulations. These
HUMAN SERVICES FOR FURTHER INFORMATION CONTACT: collections of information are subject to
Tami Belouin, Center for Biologics review by the Office of Management and
Food and Drug Administration Evaluation and Research, Food and Budget (OMB) under the Paperwork
Drug Administration, 10903 New Reduction Act of 1995 (44 U.S.C. 3501–
[Docket No. FDA–2014–D–0663] 3520). The collections of information in
Hampshire Ave., Bldg. 71, Rm. 7301,
Determining the Need for and Content Silver Spring, MD 20993–0002, 240– 21 CFR part 25 have been approved
of Environmental Assessments for 402–7911. under OMB control number 0910–0322;
Gene Therapies, Vectored Vaccines, the collections of information in 21 CFR
SUPPLEMENTARY INFORMATION:
and Related Recombinant Viral or part 312 have been approved under
Microbial Products; Guidance for I. Background OMB control number 0910–0014; and
Industry: Availability FDA is announcing the availability of the collections of information for 21
a document entitled ‘‘Determining the CFR part 601 have been approved under
AGENCY: Food and Drug Administration, Need for and Content of Environmental OMB control number 0910–0338.
HHS. Assessments for Gene Therapies, III. Comments
ACTION: Notice. Vectored Vaccines, and Related
Interested persons may submit either
Recombinant Viral or Microbial
SUMMARY: The Food and Drug electronic comments regarding this
Products; Guidance for Industry’’ dated
Administration (FDA) is announcing the document to http://www.regulations.gov
March 2015. The guidance document
availability of a document entitled or written comments to the Division of
provides IND sponsors and applicants
‘‘Determining the Need for and Content Dockets Management (see ADDRESSES). It
for a BLA or a BLA supplement, with
of Environmental Assessments for Gene is only necessary to send one set of
recommendations on considerations
Therapies, Vectored Vaccines, and comments. Identify comments with the
when assessing whether to submit an
Related Recombinant Viral or Microbial docket number found in brackets in the
EA for GTVVs. The guidance also
Products; Guidance for Industry’’ dated heading of this document. Received
contains recommendations as to what
March 2015. The guidance document comments may be seen in the Division
information should be included in an
provides investigational new drug of Dockets Management between 9 a.m.
EA and what you can expect once an EA
application (IND) sponsors and and 4 p.m., Monday through Friday, and
is filed. The guidance supplements the
applicants for a biologics license will be posted to the docket at http://
guidance entitled ‘‘Guidance for
application (BLA) or a supplement to a www.regulations.gov.
Industry: Environmental Assessment of
BLA (BLA supplement), with Human Drug and Biologics IV. Electronic Access
recommendations on considerations Applications’’ dated July 1998 (July 27,
when assessing whether to submit an Persons with access to the Internet
1998, 63 FR 40127) (1998 Guidance) and may obtain the guidance at either http://
Environmental Assessment (EA) for supersedes the recommendations for
gene therapies, vectored vaccines, and www.fda.gov/BiologicsBloodVaccines/
GTVVs in section IV.B.1 ‘‘Assessing GuidanceComplianceRegulatory
related recombinant viral or microbial Toxicity to Environmental Organisms’’
products (GTVVs). The guidance also Information/Guidances/default.htm or
in the 1998 Guidance. The guidance http://www.regulations.gov.
contains recommendations as to what announced in this notice finalizes the
information should be included in an draft guidance of the same title dated Dated: March 19, 2015.
EA and what you can expect once an EA June 2014. Leslie Kux,
is filed. The guidance announced in this In the Federal Register of June 20, Associate Commissioner for Policy.
notice finalizes the draft guidance of the 2014 (79 FR 35361), FDA announced the [FR Doc. 2015–06686 Filed 3–23–15; 8:45 am]
same title dated June 2014. availability of the draft guidance of the BILLING CODE 4164–01–P
DATES: Submit either electronic or same title dated June 2014. FDA
written comments on Agency guidances received a few comments on the draft
at any time. guidance and those comments were DEPARTMENT OF HEALTH AND
ADDRESSES: Submit written requests for considered as the guidance was HUMAN SERVICES
single copies of the guidance to the finalized. There were no changes to the
Office of Communication, Outreach and guidance except for one correction to a Centers for Disease Control and
Development, Center for Biologics technical error regarding influenza Prevention
Evaluation and Research (CBER), Food taxonomy. The guidance announced in Disease, Disability, and Injury
and Drug Administration, 10903 New this notice finalizes the draft guidance Prevention and Control Special
mstockstill on DSK4VPTVN1PROD with NOTICES
Hampshire Ave., Bldg. 71, Rm. 3128, dated June 2014. Emphasis Panel (SEP): Initial Review
Silver Spring, MD 20993–0002. Send The guidance is being issued
one self-addressed adhesive label to consistent with FDA’s good guidance The meeting announced below
assist the office in processing your practices regulation (21 CFR 10.115). concerns Economic Studies of
requests. The guidance may also be The guidance represents FDA’s current Immunization Policies and Practices,
obtained by mail by calling CBER at 1– thinking on this topic. It does not create Funding Opportunity Announcement
800–835–4709 or 240–402–7800. See or confer any rights for or on any person (FOA) IP15–001 and US Platform to
the SUPPLEMENTARY INFORMATION section and does not operate to bind FDA or the Measure Influenza Vaccine
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Document Created: 2015-12-18 11:45:19
Document Modified: 2015-12-18 11:45:19
| 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. | |
| Dates | Submit either electronic or written comments on Agency guidances at any time. | |
| 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. | |
| FR Citation | 80 FR 15617 |
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