Agency Information Collection Activities; Proposed Collection; Comment Request; New Animal Drug Applications and Supporting Regulations, and Form FDA 356V, 69630-69631 [2012-28199]

Download as PDF 69630 Federal Register / Vol. 77, No. 224 / Tuesday, November 20, 2012 / Notices Dated: November 1, 2012. Bryan Samuels, Commissioner, Administration on Children, Youth and Families. [FR Doc. 2012–28089 Filed 11–19–12; 8:45 am] BILLING CODE 4184–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2012–N–1131] Agency Information Collection Activities; Proposed Collection; Comment Request; New Animal Drug Applications and Supporting Regulations, and Form FDA 356V AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on paperwork associated with applications for new animal drugs. DATES: Submit either electronic or written comments on the collection of information by January 22, 2013. ADDRESSES: Submit electronic comments on the collection of information to https:// www.regulations.gov. Submit written comments on the collection of information to the Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. All comments should be identified with the docket number found in brackets in the heading of this document. FOR FURTHER INFORMATION CONTACT: Jonna Capezzuto, Office of Information Management, Food and Drug Administration, 1350 Piccard Dr., PIFO, Rm. 410B, Rockville, MD 20850, 301– 796–3794. SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501–3520), Federal Agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of wreier-aviles on DSK5TPTVN1PROD with SUMMARY: VerDate Mar<15>2010 15:12 Nov 19, 2012 Jkt 229001 information they conduct or sponsor. ‘‘Collection of information’’ is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes Agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal Agencies to provide a 60-day notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, before submitting the collection to OMB for approval. To comply with this requirement, FDA is publishing notice of the proposed collection of information set forth in this document. With respect to the following collection of information, FDA invites comments on these topics: (1) Whether the proposed collection of information is necessary for the proper performance of FDA’s functions, including whether the information will have practical utility; (2) the accuracy of FDA’s estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology. Presubmission Conferences, New Animal Drug Applications and Supporting Regulations and Guidance #152, and Form FDA 356V—21 CFR 514.5, 514.1, 514.4, and 514.8 (OMB Control Number 0910–0032)—Extension Under section 512(b)(3) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 360b(b)(3)), any person intending to file a new animal drug application (NADA) or supplemental NADA or a request for an investigational exemption under section 512(j) of the FD&C Act is entitled to one or more conferences with FDA to reach an agreement acceptable to FDA establishing a submission or investigational requirement. FDA and industry have found that these meetings have increased the efficiency of the drug development and drug review processes. Section 514.5 of Title 21 of the Code of Federal Regulations describes the procedures for requesting, conducting, and documenting presubmission conferences. Section 514.5(b) describes PO 00000 Frm 00041 Fmt 4703 Sfmt 4703 the information that must be included in a letter submitted by a potential applicant requesting a presubmission conference, including a proposed agenda and a list of expected participants. Section 514.5(d) describes the information that must be provided by the potential applicant to FDA at least 30 days prior to a presubmission conference. This information includes a detailed agenda, a copy of any materials to be presented at the conference, a list of proposed indications and, if available, a copy of the proposed labeling for the product under consideration, and a copy of any background material that provides scientific rationale to support the potential applicant’s position on issues listed in the agenda for the conference. Section 514.5(f) discusses the content of the memorandum of conference that will be prepared by FDA and gives the potential applicant an opportunity to seek correction to or clarification of the memorandum. Under section 512(b)(1) of the FD&C Act, any person may file a NADA seeking approval to legally market a new animal drug. Section 512(b)(1) sets forth the information required to be submitted in a NADA. FDA allows applicants to submit a complete NADA or to submit information in support of a NADA for phased review followed by submission of an administrative NADA when FDA finds all the applicable technical sections are complete. Section 514.1 of Title 21 of the Code of Federal Regulations interprets section 512(b)(1) of the FD&C Act and further describes the information that must be submitted as part of a NADA and the manner and form in which the NADA must be assembled and submitted. The application must include safety and effectiveness data, proposed labeling, product manufacturing information, and where necessary, complete information on food safety (including microbial food safety) and any methods used to determine residues of drug chemicals in edible tissue from food producing animals. Guidance #152 outlines a risk assessment approach for evaluating the microbial food safety of antimicrobial new animal drugs. FDA requests that an applicant accompany NADAs, supplemental NADAs, and requests for phased review of data to support NADAs, with the Form FDA 356V to ensure efficient and accurate processing of information to support new animal drug approval. FDA estimates the burden of the collections of information as follows: E:\FR\FM\20NON1.SGM 20NON1 69631 Federal Register / Vol. 77, No. 224 / Tuesday, November 20, 2012 / Notices TABLE 1—NADAS: ESTIMATED ANNUAL REPORTING BURDEN 1 Number of respondents 21 CFR Section/FDA Form No. 514.5(b), (d), and (f) Requesting presubmission conferences ........................................................................ 514.1 and 514.6 Applications and amended applications 514.8(b) Manufacturing changes to an approved application ............................................................................ 514.8(c)(1) Labeling and other changes to an approved application .................................................................... 514.8(c)(2) and (3) Labeling and other changes to an approved application .................................................... 514.11 Submission of data, studies and other information ................................................................................ 558.5(i) Requirements for liquid medicated feed ............ 514.1(b)(8) and 514.8(c)(1) 2 Evidence to establish safety and effectiveness ..................................................... FDA Form 356V ............................................................... Total .......................................................................... Number of responses per respondent Total annual responses Average burden per response Total hours 169 169 0.41 0.07 69 12 50 212 3,450 2,544 169 2.22 375 35 13,125 169 0.06 10 71 710 169 0.72 121 20 2,420 169 169 0.08 0.01 169 169 0.15 4.37 ........................ ........................ 14 1.7 1 5 25 739 .......................... 14 8.5 90 5 2,250 3,695 ........................ 28,217 1 There are no capital costs or operating and maintenance costs associated with this collection of information. and supplements regarding antimicrobial animal drugs that use a recommended approach to assessing antimicrobial concerns as part of the overall preapproval safety evaluation. 2 NADAs Based on the number of sponsors subject to animal drug user fees, FDA estimates that there was an average of 169 annual respondents during the 5 fiscal years, from October 1, 2008 through September 30, 2012, on which these estimates were made. We use this estimate consistently throughout the table and calculate the ‘‘total annual responses’’ by multiplying the number of responses per respondent by number of respondents. Dated: November 15, 2012. Leslie Kux, Assistant Commissioner for Policy. [FR Doc. 2012–28199 Filed 11–19–12; 8:45 am] BILLING CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2012–D–0847] Draft Guidance for IRBs, Clinical Investigators, and Sponsors: IRB Responsibilities for Reviewing the Qualifications of Investigators, Adequacy of Research Sites, and the Determination of Whether an IND/IDE Is Needed; Availability AGENCY: Food and Drug Administration, HHS. wreier-aviles on DSK5TPTVN1PROD with ACTION: Notice. The Food and Drug Administration (FDA) is announcing the availability of a draft guidance entitled ‘‘Guidance for IRBs, Clinical Investigators, and Sponsors: IRB Responsibilities for Reviewing the SUMMARY: VerDate Mar<15>2010 17:49 Nov 19, 2012 Jkt 229001 Qualifications of Investigators, Adequacy of Research Sites, and the Determination of Whether an IND/IDE Is Needed.’’ The draft guidance announced in this notice is intended to assist institutional review boards (IRBs), clinical investigators, and sponsors involved in clinical investigations of FDA-regulated products in fulfilling responsibilities related to reviewing the qualifications of investigators, adequacy of research sites, and the determination of whether an investigational new drug (IND) application or investigational device exemption (IDE) is needed in order to assure the protection of the rights and welfare of human subjects in clinical investigations. 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 January 22, 2013. Submit written requests for single copies of this draft guidance to the Division of Drug Information, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 2201, Silver Spring, MD 20993–0002 (1–888– 463–6332 or 301–796–3400); or the Office of Communication, Outreach and Development (HFM–40), Center for Biologics Evaluation and Research, Food and Drug Administration, 1401 Rockville Pike, Suite 200N, Rockville, MD 20852–1448 (1–800–835–4709 or 301–827–1800); or the Division of Small ADDRESSES: PO 00000 Frm 00042 Fmt 4703 Sfmt 4703 Manufacturers, International and Consumer Assistance, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 4622, Silver Spring, MD 20993 (1–800–638– 2041 or 301–796–7100). Send one selfaddressed adhesive label to assist the office in processing your requests. 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: Doreen Kezer, Office of Good Clinical Practice, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 5109, Silver Spring, MD 20993, 301–796–8524. SUPPLEMENTARY INFORMATION: I. Background FDA is announcing the availability of a draft guidance entitled ‘‘Guidance for IRBs, Clinical Investigators, and Sponsors: IRB Responsibilities for Reviewing the Qualifications of Investigators, Adequacy of Research Sites, and the Determination of Whether an IND/IDE Is Needed.’’ This guidance is intended to assist IRBs, clinical investigators, and sponsors involved in clinical investigations of FDA-regulated E:\FR\FM\20NON1.SGM 20NON1

Agencies

[Federal Register Volume 77, Number 224 (Tuesday, November 20, 2012)]
[Notices]
[Pages 69630-69631]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-28199]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-N-1131]

Agency Information Collection Activities; Proposed Collection;
Comment Request; New Animal Drug Applications and Supporting
Regulations, and Form FDA 356V

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing an
opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(the PRA), Federal Agencies are required to publish notice in the
Federal Register concerning each proposed collection of information,
including each proposed extension of an existing collection of
information, and to allow 60 days for public comment in response to the
notice. This notice solicits comments on paperwork associated with
applications for new animal drugs.

DATES: Submit either electronic or written comments on the collection
of information by January 22, 2013.

ADDRESSES: Submit electronic comments on the collection of information
to https://www.regulations.gov. Submit written comments on the
collection of information to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852. All comments should be identified with the docket
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Jonna Capezzuto, Office of Information
Management, Food and Drug Administration, 1350 Piccard Dr., PIFO, Rm.
410B, Rockville, MD 20850, 301-796-3794.

SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal
Agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal Agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information,
before submitting the collection to OMB for approval. To comply with
this requirement, FDA is publishing notice of the proposed collection
of information set forth in this document.
With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.

Presubmission Conferences, New Animal Drug Applications and Supporting
Regulations and Guidance 152, and Form FDA 356V--21 CFR 514.5,
514.1, 514.4, and 514.8 (OMB Control Number 0910-0032)--Extension

Under section 512(b)(3) of the Federal Food, Drug, and Cosmetic Act
(the FD&C Act) (21 U.S.C. 360b(b)(3)), any person intending to file a
new animal drug application (NADA) or supplemental NADA or a request
for an investigational exemption under section 512(j) of the FD&C Act
is entitled to one or more conferences with FDA to reach an agreement
acceptable to FDA establishing a submission or investigational
requirement. FDA and industry have found that these meetings have
increased the efficiency of the drug development and drug review
processes.
Section 514.5 of Title 21 of the Code of Federal Regulations
describes the procedures for requesting, conducting, and documenting
presubmission conferences. Section 514.5(b) describes the information
that must be included in a letter submitted by a potential applicant
requesting a presubmission conference, including a proposed agenda and
a list of expected participants. Section 514.5(d) describes the
information that must be provided by the potential applicant to FDA at
least 30 days prior to a presubmission conference. This information
includes a detailed agenda, a copy of any materials to be presented at
the conference, a list of proposed indications and, if available, a
copy of the proposed labeling for the product under consideration, and
a copy of any background material that provides scientific rationale to
support the potential applicant's position on issues listed in the
agenda for the conference. Section 514.5(f) discusses the content of
the memorandum of conference that will be prepared by FDA and gives the
potential applicant an opportunity to seek correction to or
clarification of the memorandum.
Under section 512(b)(1) of the FD&C Act, any person may file a NADA
seeking approval to legally market a new animal drug. Section 512(b)(1)
sets forth the information required to be submitted in a NADA. FDA
allows applicants to submit a complete NADA or to submit information in
support of a NADA for phased review followed by submission of an
administrative NADA when FDA finds all the applicable technical
sections are complete.
Section 514.1 of Title 21 of the Code of Federal Regulations
interprets section 512(b)(1) of the FD&C Act and further describes the
information that must be submitted as part of a NADA and the manner and
form in which the NADA must be assembled and submitted. The application
must include safety and effectiveness data, proposed labeling, product
manufacturing information, and where necessary, complete information on
food safety (including microbial food safety) and any methods used to
determine residues of drug chemicals in edible tissue from food
producing animals. Guidance 152 outlines a risk assessment
approach for evaluating the microbial food safety of antimicrobial new
animal drugs. FDA requests that an applicant accompany NADAs,
supplemental NADAs, and requests for phased review of data to support
NADAs, with the Form FDA 356V to ensure efficient and accurate
processing of information to support new animal drug approval.
FDA estimates the burden of the collections of information as
follows:

[[Page 69631]]

Table 1--NADAs: Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of
21 CFR Section/FDA Form No. Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
----------------------------------------------------------------------------------------------------------------
514.5(b), (d), and (f) 169 0.41 69 50 3,450
Requesting presubmission
conferences..................
514.1 and 514.6 Applications 169 0.07 12 212 2,544
and amended applications.....
514.8(b) Manufacturing changes 169 2.22 375 35 13,125
to an approved application...
514.8(c)(1) Labeling and other 169 0.06 10 71 710
changes to an approved
application..................
514.8(c)(2) and (3) Labeling 169 0.72 121 20 2,420
and other changes to an
approved application.........
514.11 Submission of data, 169 0.08 14 1 14
studies and other information
558.5(i) Requirements for 169 0.01 1.7 5 8.5
liquid medicated feed........
514.1(b)(8) and 514.8(c)(1) 169 0.15 25 90 2,250
\2\ Evidence to establish
safety and effectiveness.....
FDA Form 356V................. 169 4.37 739 5 3,695
---------------------------------------------------------------------------------
Total..................... .............. .............. ............... .............. 28,217
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
\2\ NADAs and supplements regarding antimicrobial animal drugs that use a recommended approach to assessing
antimicrobial concerns as part of the overall preapproval safety evaluation.

Based on the number of sponsors subject to animal drug user fees,
FDA estimates that there was an average of 169 annual respondents
during the 5 fiscal years, from October 1, 2008 through September 30,
2012, on which these estimates were made. We use this estimate
consistently throughout the table and calculate the ``total annual
responses'' by multiplying the number of responses per respondent by
number of respondents.

Dated: November 15, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-28199 Filed 11-19-12; 8:45 am]
BILLING CODE 4160-01-P

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.