Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Current Good Manufacturing Practice Regulations for Type A Medicated Articles, 35360-35361 [2014-14471]

Download as PDF 35360 Federal Register / Vol. 79, No. 119 / Friday, June 20, 2014 / Notices TABLE 4—ESTIMATED ANNUAL RECORDKEEPING BURDEN—Continued [Nonregistered unlicensed mixer-feeders] 1 Number of recordkeepers Total ........................................... 1 There Number of records per recordkeeper Total annual records Average burden per recordkeeper ........................ 21 CFR Section ........................ ........................ ........................................................... Dated: June 17, 2014. Leslie Kux, Assistant Commissioner for Policy. [FR Doc. 2014–14472 Filed 6–19–14; 8:45 am] BILLING CODE 4160–01–P OMB, Attn: FDA Desk Officer, FAX: 202–395–7285, or emailed to oira_submission@omb.eop.gov. All comments should be identified with the OMB control number 0910–0154. Also include the FDA docket number found in brackets in the heading of this document. FDA PRA Staff, Office of Operations, Food and Drug Administration, 8455 Colesville Rd., COLE–14526, Silver Spring, MD 20993–0002, PRAStaff@fda.hhs.gov. FOR FURTHER INFORMATION CONTACT: In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance. SUPPLEMENTARY INFORMATION: DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2004–N–0389] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Current Good Manufacturing Practice Regulations for Type A Medicated Articles Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995. DATES: Fax written comments on the collection of information by July 21, 2014. ADDRESSES: To ensure that comments on the information collection are received, OMB recommends that written comments be faxed to the Office of Information and Regulatory Affairs, SUMMARY: mstockstill on DSK4VPTVN1PROD with NOTICES 331,976 are no capital costs or operating and maintenance costs associated with this collection of information. The estimate of time required for record preparation and maintenance is based on Agency communications with industry. Other information needed to finally calculate the total burden hours (i.e., number of recordkeepers, number of medicated feeds being manufactured, etc.) is derived from Agency records and experience. AGENCY: Total hours Current Good Manufacturing Practice Regulations for Type A Medicated Articles—21 CFR Part 226 (OMB Control Number 0910–0154)—Extension Under section 501 of the Federal Food, Drug, and Cosmetic Act (the FD&C Act), FDA has the statutory authority to issue current good manufacturing practice (cGMP) regulations for drugs, including Type A medicated articles. A Type A medicated article is a feed product containing a concentrated drug diluted with a feed carrier substance. A Type A medicated article is intended solely for use in the manufacture of another Type A medicated article or a Type B or Type C medicated feed. Medicated feeds are administered to animals for the prevention, cure, mitigation, or treatment of disease or for growth promotion and feed efficiency. Statutory requirements for cGMPs for Type A medicated articles have been codified in part 226 (21 CFR part 226). Type A medicated articles which are not manufactured in accordance with these regulations are considered adulterated under section 501(a)(2)(B) of the FD&C Act (21 U.S.C. 351(a)(2)(B). Under part 226, a manufacturer is required to establish, maintain, and retain records for Type A medicated articles, including records to document procedures required under the manufacturing process to assure that proper quality control is maintained. Such records would, for example, contain information concerning receipt and inventory of drug components, batch production, laboratory assay results (i.e., batch and stability testing) and product distribution. This information is needed so that FDA can monitor drug usage and possible misformulation of Type A medicated articles. The information could also prove useful to FDA in investigating product defects when a drug is recalled. In addition, FDA will use the cGMP criteria in part 226 to determine whether or not the systems used by manufacturers of Type A medicated articles are adequate to assure that their medicated articles meet the requirements of the FD&C Act as to safety and also meet the article’s claimed identity, strength, quality, and purity, as required by section 501(a)(2)(B) of the FD&C Act. The respondents for Type A medicated articles are pharmaceutical firms that manufacture both human and veterinary drugs, those firms that produce only veterinary drugs, and commercial feed mills. In the Federal Register of April 7, 2014 (79 FR 19093), FDA published a 60-day notice requesting public comment on the proposed collection of information. No comments were received. FDA estimates the burden of this collection of information as follows: TABLE 1—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1 Number of recordkeepers 21 CFR Section 226.42 ............................................... 226.58 ............................................... 226.80 ............................................... VerDate Mar<15>2010 22:31 Jun 19, 2014 Jkt 232001 Number of records per recordkeeper 65 65 65 PO 00000 Frm 00051 Total annual records 260 260 260 Fmt 4703 16,900 16,900 16,900 Sfmt 4703 Average burden per recordkeeper 0.75 (45 minutes) ............................. 1.75 .................................................. 0.75 (45 minutes) ............................. E:\FR\FM\20JNN1.SGM 20JNN1 Total hours 12,675 29,575 12,675 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

Agencies

[Federal Register Volume 79, Number 119 (Friday, June 20, 2014)]
[Notices]
[Pages 35360-35361]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-14471]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2004-N-0389]

Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Current Good
Manufacturing Practice Regulations for Type A Medicated Articles

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing that a
proposed collection of information has been submitted to the Office of
Management and Budget (OMB) for review and clearance under the
Paperwork Reduction Act of 1995.

DATES: Fax written comments on the collection of information by July
21, 2014.

ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be faxed to the Office
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer,
FAX: 202-395-7285, or emailed to oira_submission@omb.eop.gov. All
comments should be identified with the OMB control number 0910-0154.
Also include the FDA docket number found in brackets in the heading of
this document.

FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations,
Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver
Spring, MD 20993-0002, PRAStaff@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.

Current Good Manufacturing Practice Regulations for Type A Medicated
Articles--21 CFR Part 226 (OMB Control Number 0910-0154)--Extension

Under section 501 of the Federal Food, Drug, and Cosmetic Act (the
FD&C Act), FDA has the statutory authority to issue current good
manufacturing practice (cGMP) regulations for drugs, including Type A
medicated articles. A Type A medicated article is a feed product
containing a concentrated drug diluted with a feed carrier substance. A
Type A medicated article is intended solely for use in the manufacture
of another Type A medicated article or a Type B or Type C medicated
feed. Medicated feeds are administered to animals for the prevention,
cure, mitigation, or treatment of disease or for growth promotion and
feed efficiency.
Statutory requirements for cGMPs for Type A medicated articles have
been codified in part 226 (21 CFR part 226). Type A medicated articles
which are not manufactured in accordance with these regulations are
considered adulterated under section 501(a)(2)(B) of the FD&C Act (21
U.S.C. 351(a)(2)(B). Under part 226, a manufacturer is required to
establish, maintain, and retain records for Type A medicated articles,
including records to document procedures required under the
manufacturing process to assure that proper quality control is
maintained. Such records would, for example, contain information
concerning receipt and inventory of drug components, batch production,
laboratory assay results (i.e., batch and stability testing) and
product distribution.
This information is needed so that FDA can monitor drug usage and
possible misformulation of Type A medicated articles. The information
could also prove useful to FDA in investigating product defects when a
drug is recalled. In addition, FDA will use the cGMP criteria in part
226 to determine whether or not the systems used by manufacturers of
Type A medicated articles are adequate to assure that their medicated
articles meet the requirements of the FD&C Act as to safety and also
meet the article's claimed identity, strength, quality, and purity, as
required by section 501(a)(2)(B) of the FD&C Act. The respondents for
Type A medicated articles are pharmaceutical firms that manufacture
both human and veterinary drugs, those firms that produce only
veterinary drugs, and commercial feed mills.
In the Federal Register of April 7, 2014 (79 FR 19093), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. No comments were received.
FDA estimates the burden of this collection of information as
follows:

Table 1--Estimated Annual Recordkeeping Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of
21 CFR Section Number of records per Total annual Average burden Total hours
recordkeepers recordkeeper records per recordkeeper
----------------------------------------------------------------------------------------------------------------
226.42........................ 65 260 16,900 0.75 (45 12,675
minutes).
226.58........................ 65 260 16,900 1.75............ 29,575
226.80........................ 65 260 16,900 0.75 (45 12,675
minutes).

[[Page 35361]]

226.102....................... 65 260 16,900 1.75............ 29,575
226.110....................... 65 260 16,900 0.25 (15 4,225
minutes).
226.115....................... 65 10 650 0.5 (30 minutes) 325
------------------------------------------------ ---------------
Total................. .............. .............. .............. ................ 89,050
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection.

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.

Dated: June 16, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-14471 Filed 6-19-14; 8:45 am]
BILLING CODE 4160-01-P

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