Draft Guidance for Industry: Determining the Need for and Content of Environmental Assessments for Gene Therapies, Vectored Vaccines, and Related Recombinant Viral or Microbial Products; Availability, 35361-35362 [2014-14470]

Download as PDF Federal Register / Vol. 79, No. 119 / Friday, June 20, 2014 / Notices 35361 TABLE 1—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1—Continued Number of recordkeepers 21 CFR Section Number of records per recordkeeper Total annual records Average burden per recordkeeper Total hours 226.102 ............................................. 226.110 ............................................. 226.115 ............................................. 65 65 65 260 260 10 16,900 16,900 650 1.75 .................................................. 0.25 (15 minutes) ............................. 0.5 (30 minutes) ............................... 29,575 4,225 325 Total .................................... ........................ ........................ ........................ ........................................................... 89,050 1 There are no capital costs or operating and maintenance costs associated with this collection. Dated: June 16, 2014. Leslie Kux, Assistant Commissioner for Policy. EA and what sponsors and applicants can expect once an EA is filed. The guidance, when finalized, will supplement the guidance entitled ‘‘Guidance for Industry: Environmental Assessment of Human Drug and Biologics Applications,’’ dated July 1998 (1998 Guidance) and will also supersede those recommendations for GTVVs in section IV.B.1 Assessing Toxicity to Environmental Organisms’’ of the guidance. [FR Doc. 2014–14471 Filed 6–19–14; 8:45 am] DATES: The estimate of time required for record preparation and maintenance is based on previous Agency communications with industry. Other information needed to calculate the total burden hours (i.e., manufacturing sites, number of Type A medicated articles being manufactured, etc.) are derived from Agency records and experience. 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comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by September 18, 2014. BILLING CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2014–D–0663] Draft Guidance for Industry: Determining the Need for and Content of Environmental Assessments for Gene Therapies, Vectored Vaccines, and Related Recombinant Viral or Microbial Products; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is announcing the availability of a draft document entitled ‘‘Guidance for Industry: Determining the Need for and Content of Environmental Assessments for Gene Therapies, Vectored Vaccines, and Related Recombinant Viral or Microbial Products’’ dated June 2014. The draft guidance document provides investigational new drug application (IND) sponsors and applicants for a biologics license application (BLA), or a supplement to a BLA, 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 mstockstill on DSK4VPTVN1PROD with NOTICES SUMMARY: VerDate Mar<15>2010 22:31 Jun 19, 2014 Jkt 232001 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 240–402–7800. See the SUPPLEMENTARY INFORMATION section for electronic access to the draft guidance document. Submit electronic comments on the draft guidance to https:// www.regulations.gov. Submit written comments to the Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. ADDRESSES: FOR FURTHER INFORMATION CONTACT: 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: PO 00000 Frm 00052 Fmt 4703 Sfmt 4703 I. Background FDA is announcing the availability of a draft document entitled ‘‘Guidance for Industry: Determining the Need for and Content of Environmental Assessments for Gene Therapies, Vectored Vaccines, and Related Recombinant Viral or Microbial Products’’ dated June 2014. The draft guidance document provides IND sponsors and applicants for a BLA, or a supplement to a BLA, 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 sponsors and applicants can expect once an EA is filed. Products addressed in the guidance include all GTVVs, but not live-attenuated viral or microbial vaccines created by traditional methods such as serial passaging or recombinant protein-based vaccines. The guidance, when finalized, will supplement the 1998 Guidance, and will also supersede those recommendations for GTVVs in section IV.B.1 entitled ‘‘Assessing Toxicity to Environmental Organisms’’ of the 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 this topic. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirement of the applicable statutes and regulations. II. Paperwork Reduction Act of 1995 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 25 have been approved under OMB control number 0910–0322; the collections of E:\FR\FM\20JNN1.SGM 20JNN1 35362 Federal Register / Vol. 79, No. 119 / Friday, June 20, 2014 / Notices 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. DEPARTMENT OF HEALTH AND HUMAN SERVICES III. Comments Canned Tuna Deviating From Identity Standard; Temporary Permit for Market Testing The draft guidance is being distributed for comment purposes only and is not intended for implementation at this time. Interested persons may submit either electronic comments regarding this document to https:// www.regulations.gov or written comments 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 https:// www.regulations.gov. IV. Electronic Access Persons with access to the Internet may obtain the draft guidance at either https://www.fda.gov/BiologicsBlood Vaccines/GuidanceCompliance RegulatoryInformation/Guidances/ default.htm or https:// www.regulations.gov. Dated: June 16, 2014. Leslie Kux, Assistant Commissioner for Policy. [FR Doc. 2014–14470 Filed 6–19–14; 8:45 am] BILLING CODE 4160–01–P Food and Drug Administration [Docket No. FDA–2012–P–1189] AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA or we) received applications for temporary permits from Bumble Bee Foods, LLC; Chicken of the Sea International; and StarKist Seafood Company (the applicants). We are announcing that we have issued temporary permits to the applicants to market test products (designated as ‘‘canned tuna’’ products) that deviate from the U.S. standard of identity for canned tuna. The purpose of the temporary permits is to market test the product throughout the United States and the Commonwealth of Puerto Rico. The permits will allow the applicants to measure consumer acceptance of the products and assess the commercial feasibility of the products. DATES: These permits are effective for 15 months, beginning on the date each applicant introduces or causes the introduction of the test products into interstate commerce, but not later than September 18, 2014. FOR FURTHER INFORMATION CONTACT: Loretta A. Carey, Center for Food Safety and Applied Nutrition (HFS–820), Food SUMMARY: and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, 240–402–2371. We have issued a temporary permit to each of the following applicants: Bumble Bee Foods, LLC; Chicken of the Sea International; and StarKist Seafood Company. We are issuing these temporary permits in accordance with 21 CFR 130.17, which addresses temporary permits for interstate shipment of experimental packs of food varying from the requirements of standards of identity issued under section 401 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 341). These permits cover limited interstate marketing tests of products identified as ‘‘canned tuna.’’ These test products deviate from the U.S. standard of identity for canned tuna (21 CFR 161.190) in that they are labeled without the statement ‘‘Below Standard in Fill’’ as required in § 161.190(c)(4) and 21 CFR 130.14(b). The test products meet all the requirements of the standard with the exception of this deviation. The purpose of these temporary permits is to market test the product throughout the United States and the Commonwealth of Puerto Rico. These permits will allow the applicants to measure customer acceptance of the products and assess commercial feasibility of the products. Table 1 lists the amount of product for distribution and the manufacturers of the products for each of the applicants. The retail cans for the products are of various sizes. SUPPLEMENTARY INFORMATION: TABLE 1—AMOUNT, MANUFACTURER, AND LOCATION BY APPLICANT Amount of canned tuna for distribution Manufacturer and location Bumble Bee Foods, LLC, 9655 Granite Ridge Dr., San Diego, CA 92123. mstockstill on DSK4VPTVN1PROD with NOTICES Applicant 141,000,000 pounds (lbs) (63,800,905 kilograms (kgs)). Asian Alliance, 8/8 Moo 3, Rama 2 Rd., Bunbor, Muang, Samutsakorn 74000, Thailand. Chicken of the Sea Georgia Canning, 129 North Commerce Dr., Lyons, GA 30436. Bumble Bee Seafoods, Inc., 13100 Arctic Circle, Santa Fe Springs, CA 90670. Chotiwat Manufacturing Co., 84/22 Moo 7, Asia Highway Rd. #43, P.O. Box 37, T. Korhong, Hatyai Songkhla, Thailand 90110. Gentuna (GTC/Century), P.O. Tambler, General Santos City, South Cotabato, Philippines 9500. I.S.A. Value Co., Ltd. (Narong), 101/6 Mu 6, Soi Muangsakul Road, Samaedam, Bangkhutien, Bangkok 10150, Thailand. Pataya Foods, 90/6 Tambol Tarsai, Muang, Samutprakarn, Pataya, Thailand. PT Aneka Tuna, Jalan Raya SurabayaMalang Km. 38, Gempol, Pasuruan 67155 Jawa Timur. R.S. Cannery Co., Ltd., 255/1 Industrial Soi 3, Industrial Estate, Samutprakarn 10280, Thailand. VerDate Mar<15>2010 22:31 Jun 19, 2014 Jkt 232001 PO 00000 Frm 00053 Fmt 4703 Sfmt 4703 E:\FR\FM\20JNN1.SGM 20JNN1

Agencies

[Federal Register Volume 79, Number 119 (Friday, June 20, 2014)]
[Notices]
[Pages 35361-35362]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-14470]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-D-0663]


Draft Guidance for Industry: Determining the Need for and Content 
of Environmental Assessments for Gene Therapies, Vectored Vaccines, and 
Related Recombinant Viral or Microbial Products; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a draft document entitled ``Guidance for Industry: 
Determining the Need for and Content of Environmental Assessments for 
Gene Therapies, Vectored Vaccines, and Related Recombinant Viral or 
Microbial Products'' dated June 2014. The draft guidance document 
provides investigational new drug application (IND) sponsors and 
applicants for a biologics license application (BLA), or a supplement 
to a BLA, 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 sponsors and applicants can expect 
once an EA is filed. The guidance, when finalized, will supplement the 
guidance entitled ``Guidance for Industry: Environmental Assessment of 
Human Drug and Biologics Applications,'' dated July 1998 (1998 
Guidance) and will also supersede those recommendations for GTVVs in 
section IV.B.1 Assessing Toxicity to Environmental Organisms'' of the 
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 September 18, 2014.

ADDRESSES: 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 240-402-7800. See 
the SUPPLEMENTARY INFORMATION section for electronic access to the 
draft guidance document.
    Submit electronic comments on the draft guidance to https://www.regulations.gov. Submit written comments to the Division of Dockets 
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: 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 draft document entitled 
``Guidance for Industry: Determining the Need for and Content of 
Environmental Assessments for Gene Therapies, Vectored Vaccines, and 
Related Recombinant Viral or Microbial Products'' dated June 2014. The 
draft guidance document provides IND sponsors and applicants for a BLA, 
or a supplement to a BLA, 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 sponsors and applicants can expect once an EA is filed. Products 
addressed in the guidance include all GTVVs, but not live-attenuated 
viral or microbial vaccines created by traditional methods such as 
serial passaging or recombinant protein-based vaccines. The guidance, 
when finalized, will supplement the 1998 Guidance, and will also 
supersede those recommendations for GTVVs in section IV.B.1 entitled 
``Assessing Toxicity to Environmental Organisms'' of the 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 this topic. It does 
not create or confer any rights for or on any person and does not 
operate to bind FDA or the public. An alternative approach may be used 
if such approach satisfies the requirement of the applicable statutes 
and regulations.

II. Paperwork Reduction Act of 1995

    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 25 have been approved under 
OMB control number 0910-0322; the collections of

[[Page 35362]]

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

    The draft guidance is being distributed for comment purposes only 
and is not intended for implementation at this time. Interested persons 
may submit either electronic comments regarding this document to https://www.regulations.gov or written comments 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 https://www.regulations.gov.

IV. Electronic Access

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

    Dated: June 16, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-14470 Filed 6-19-14; 8:45 am]
BILLING CODE 4160-01-P
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