Agency Information Collection Activities; Proposed Collection; Comment Request; Reporting Associated With New Animal Drug Applications, 10871-10873 [2016-04575]

Download as PDF Federal Register / Vol. 81, No. 41 / Wednesday, March 2, 2016 / Notices 10871 DEPARTMENT OF HEALTH AND HUMAN SERVICES DEPARTMENT OF HEALTH AND HUMAN SERVICES manner detailed (see ‘‘Written/Paper Submissions’’ and ‘‘Instructions’’). Food and Drug Administration Food and Drug Administration Written/Paper Submissions [Docket No FDA–2016–N–0628] [Docket No. FDA–2015–N–1837] Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Electronic User Fee Payment Request Forms AGENCY: Food and Drug Administration, Notice. The Food and Drug Administration (FDA) is announcing that a collection of information entitled ‘‘Electronic User Fee Payment Request Forms’’ has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995. 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: On September 30, 2015, the Agency submitted a proposed collection of information entitled ‘‘Electronic User Fee Payment Request Forms’’ to OMB for review and clearance under 44 U.S.C. 3507. An Agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. OMB has now approved the information collection and has assigned OMB control number 0910–0805. The approval expires on November 20, 2018. A copy of the supporting statement for this information collection is available on the Internet at https:// www.reginfo.gov/public/do/PRAMain. SUPPLEMENTARY INFORMATION: Dated: February 25, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016–04574 Filed 3–1–16; 8:45 am] BILLING CODE 4164–01–P VerDate Sep<11>2014 19:10 Mar 01, 2016 Food and Drug Administration, HHS. Notice. The Food and Drug Administration (FDA, we) 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 the collection of information associated with new animal drug applications. DATES: Submit either electronic or written comments on the collection of information by May 2, 2016. ADDRESSES: You may submit comments as follows: SUMMARY: SUMMARY: mstockstill on DSK4VPTVN1PROD with NOTICES AGENCY: ACTION: HHS. ACTION: Agency Information Collection Activities; Proposed Collection; Comment Request; Reporting Associated With New Animal Drug Applications Jkt 238001 Electronic Submissions Submit electronic comments in the following way: • Federal eRulemaking Portal: https:// www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to https:// 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 https://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 PO 00000 Frm 00045 Fmt 4703 Sfmt 4703 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– 2016–N–0628 for Agency Information Collection Activities; Proposed Collection; Comment Request; Reporting Associated with New Animal Drug Applications. Received comments will be placed in the docket and, except for those submitted as ‘‘Confidential Submissions,’’ publicly viewable at https://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 https:// 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: https://www.fda.gov/ E:\FR\FM\02MRN1.SGM 02MRN1 10872 Federal Register / Vol. 81, No. 41 / Wednesday, March 2, 2016 / Notices regulatoryinformation/dockets/ default.htm. Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to https:// 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. 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. 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 SUPPLEMENTARY INFORMATION: 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. Reporting Associated With New Animal Drug Applications (NADA)—21 CFR 514.1, 514.4, 514.5, 514.6, 514.8, 514.11, 558.5 (OMB Control Number 0910– 0032)—Extension Under Section 512(b)(1) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 360b(b)(1)), any person may file a new animal drug application (NADA) seeking our approval to legally market a new animal drug. Section 512(b)(1) sets forth the information required to be submitted in a NADA. Sections 514.1, 514.4, 514.6, 514.8, and 514.11 of our regulations (21 CFR 514.1, 514.4, 514.6, 514.8, and 514.11) further specify the information that the NADA must contain. 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. FDA Guidance #152 outlines a risk assessment approach for evaluating the microbial food safety of antimicrobial new animal drugs. We request that applicants utilize Form FDA 356V, as appropriate, to ensure efficient and accurate processing of information to support new animal drug approval. Under section 512(b)(3) of the FD&C Act, any person intending to file a 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 us prior to making a submission. Section 514.5 of our regulations (21 CFR 514.5) describes the procedures for requesting, conducting, and documenting pre-submission conferences. We have found that these meetings have increased the efficiency of the drug development and drug review processes. We encourage sponsors to submit data for review at the most appropriate and productive times in the drug development process. Rather than submitting all data for review as part of a complete application, we have found that the submission of data supporting discrete technical sections during the investigational phase of the new animal drug is the most appropriate and productive. This ‘‘phased review’’ of data submissions has created efficiencies for both us and the animal pharmaceutical industry. Finally, § 558.5(i) of our regulations (21 CFR 558.5(i)) describes the procedure for requesting a waiver of the labeling requirements of § 558.5(h) in the event that there is evidence to indicate that it is unlikely a new animal drug would be used in the manufacture of a liquid medicated feed. The reporting associated with NADAs and related submissions is necessary to ensure that new animal drugs are in compliance with section 512(b)(1) of the FD&C Act. We use the information collected to review the data, labeling and manufacturing controls and procedures to evaluate the safety and effectiveness of the proposed new animal drug. We estimate the burden of this collection of information as follows: TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1 Number of respondents mstockstill on DSK4VPTVN1PROD with NOTICES 21 CFR Section; activity 514.1 & 514.6; applications and amended applications ...... 514.1(b)(8) and 514.8(c)(1); evidence to establish safety and effectiveness ............................................................. 514.5(b), (d), (f); requesting presubmission conferences ... 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) & (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 ................. Form FDA 356V ................................................................... VerDate Sep<11>2014 19:10 Mar 01, 2016 Jkt 238001 PO 00000 Frm 00046 Number of responses per respondent Average burden per response Total annual responses Total hours 182 9 212 1,908 182 182 .10 .49 19 89 90 50 1,710 4,450 182 1.40 255 35 8,925 182 .05 10 71 710 182 182 182 182 Fmt 4703 .05 .43 .09 .01 2.92 79 16 1 531 20 1 5 5 1,580 16 5 2,655 Sfmt 4703 E:\FR\FM\02MRN1.SGM 02MRN1 Federal Register / Vol. 81, No. 41 / Wednesday, March 2, 2016 / Notices 10873 TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1—Continued Number of respondents 21 CFR Section; activity Total .............................................................................. Number of responses per respondent ........................ ........................ Average burden per response Total annual responses 1009 ........................ Total hours 21,959 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 pre-approval safety evaluation. Based on the number of sponsors subject to animal drug user fees, we estimate an average of 182 annual respondents during the 5 fiscal years, from October 1, 2010 through September 30, 2014, on which these estimates were made. We use this estimate consistently throughout the table and calculate the ‘‘annual frequency per respondent’’ by dividing the total annual responses by the total number of respondents. We base our estimates of the average burden per response on our experience with NADAs and related submissions. Dated: February 25, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016–04575 Filed 3–1–16; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration National Vaccine Injury Compensation Program; List of Petitions Received Health Resources and Services Administration, HHS. ACTION: Notice. AGENCY: The Health Resources and Services Administration (HRSA) is publishing this notice of petitions received under the National Vaccine Injury Compensation Program (the Program), as required by Section 2112(b)(2) of the Public Health Service (PHS) Act, as amended. While the Secretary of Health and Human Services is named as the respondent in all proceedings brought by the filing of petitions for compensation under the Program, the United States Court of Federal Claims is charged by statute with responsibility for considering and acting upon the petitions. FOR FURTHER INFORMATION CONTACT: For information about requirements for filing petitions, and the Program in general, contact the Clerk, United States Court of Federal Claims, 717 Madison Place NW., Washington, DC 20005, (202) 357–6400. For information on mstockstill on DSK4VPTVN1PROD with NOTICES SUMMARY: VerDate Sep<11>2014 19:10 Mar 01, 2016 Jkt 238001 HRSA’s role in the Program, contact the Director, National Vaccine Injury Compensation Program, 5600 Fishers Lane, Room 11C–26, Rockville, MD 20857; (301) 443–6593, or visit our Web site at: https://www.hrsa.gov/ vaccinecompensation/. SUPPLEMENTARY INFORMATION: The Program provides a system of no-fault compensation for certain individuals who have been injured by specified childhood vaccines. Subtitle 2 of Title XXI of the PHS Act, 42 U.S.C. 300aa– 10 et seq., provides that those seeking compensation are to file a petition with the U.S. Court of Federal Claims and to serve a copy of the petition on the Secretary of Health and Human Services, who is named as the respondent in each proceeding. The Secretary has delegated this responsibility under the Program to HRSA. The Court is directed by statute to appoint special masters who take evidence, conduct hearings as appropriate, and make initial decisions as to eligibility for, and amount of, compensation. A petition may be filed with respect to injuries, disabilities, illnesses, conditions, and deaths resulting from vaccines described in the Vaccine Injury Table (the Table) set forth at 42 CFR 100.3. This Table lists for each covered childhood vaccine the conditions that may lead to compensation and, for each condition, the time period for occurrence of the first symptom or manifestation of onset or of significant aggravation after vaccine administration. Compensation may also be awarded for conditions not listed in the Table and for conditions that are manifested outside the time periods specified in the Table, but only if the petitioner shows that the condition was caused by one of the listed vaccines. Section 2112(b)(2) of the PHS Act, 42 U.S.C. 300aa–12(b)(2), requires that ‘‘[w]ithin 30 days after the Secretary receives service of any petition filed under section 2111 the Secretary shall publish notice of such petition in the Federal Register.’’ Set forth below is a list of petitions received by HRSA on January 1, 2016, through January 31, 2016. This list provides the name of PO 00000 Frm 00047 Fmt 4703 Sfmt 4703 petitioner, city and state of vaccination (if unknown then city and state of person or attorney filing claim), and case number. In cases where the Court has redacted the name of a petitioner and/or the case number, the list reflects such redaction. Section 2112(b)(2) also provides that the special master ‘‘shall afford all interested persons an opportunity to submit relevant, written information’’ relating to the following: 1. The existence of evidence ‘‘that there is not a preponderance of the evidence that the illness, disability, injury, condition, or death described in the petition is due to factors unrelated to the administration of the vaccine described in the petition,’’ and 2. Any allegation in a petition that the petitioner either: a. ‘‘[S]ustained, or had significantly aggravated, any illness, disability, injury, or condition not set forth in the Vaccine Injury Table but which was caused by’’ one of the vaccines referred to in the Table, or b. ‘‘[S]ustained, or had significantly aggravated, any illness, disability, injury, or condition set forth in the Vaccine Injury Table the first symptom or manifestation of the onset or significant aggravation of which did not occur within the time period set forth in the Table but which was caused by a vaccine’’ referred to in the Table. In accordance with Section 2112(b)(2), all interested persons may submit written information relevant to the issues described above in the case of the petitions listed below. Any person choosing to do so should file an original and three (3) copies of the information with the Clerk of the U.S. Court of Federal Claims at the address listed above (under the heading FOR FURTHER INFORMATION CONTACT), with a copy to HRSA addressed to Director, Division of Injury Compensation Programs, Healthcare Systems Bureau, 5600 Fishers Lane, 08N146B, Rockville, MD 20857. The Court’s caption (Petitioner’s Name v. Secretary of Health and Human Services) and the docket number assigned to the petition should be used as the caption for the written submission. Chapter 35 of title 44, United States Code, related to E:\FR\FM\02MRN1.SGM 02MRN1

Agencies

[Federal Register Volume 81, Number 41 (Wednesday, March 2, 2016)]
[Notices]
[Pages 10871-10873]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-04575]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No FDA-2016-N-0628]

Agency Information Collection Activities; Proposed Collection;
Comment Request; Reporting Associated With New Animal Drug Applications

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA, we) 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 the collection of information
associated with new animal drug applications.

DATES: Submit either electronic or written comments on the collection
of information by May 2, 2016.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

Submit electronic comments in the following way:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://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 https://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-2016-N-0628 for Agency Information Collection Activities; Proposed
Collection; Comment Request; Reporting Associated with New Animal Drug
Applications. Received comments will be placed in the docket and,
except for those submitted as ``Confidential Submissions,'' publicly
viewable at https://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 https://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: https://www.fda.gov/

[[Page 10872]]

regulatoryinformation/dockets/default.htm.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://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.

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: 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.

Reporting Associated With New Animal Drug Applications (NADA)--21 CFR
514.1, 514.4, 514.5, 514.6, 514.8, 514.11, 558.5 (OMB Control Number
0910-0032)--Extension

Under Section 512(b)(1) of the Federal Food, Drug, and Cosmetic Act
(the FD&C Act) (21 U.S.C. 360b(b)(1)), any person may file a new animal
drug application (NADA) seeking our approval to legally market a new
animal drug. Section 512(b)(1) sets forth the information required to
be submitted in a NADA. Sections 514.1, 514.4, 514.6, 514.8, and 514.11
of our regulations (21 CFR 514.1, 514.4, 514.6, 514.8, and 514.11)
further specify the information that the NADA must contain. 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. FDA Guidance #152 outlines a risk
assessment approach for evaluating the microbial food safety of
antimicrobial new animal drugs. We request that applicants utilize Form
FDA 356V, as appropriate, to ensure efficient and accurate processing
of information to support new animal drug approval.
Under section 512(b)(3) of the FD&C Act, any person intending to
file a 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 us prior to making a submission. Section 514.5 of
our regulations (21 CFR 514.5) describes the procedures for requesting,
conducting, and documenting pre-submission conferences. We have found
that these meetings have increased the efficiency of the drug
development and drug review processes. We encourage sponsors to submit
data for review at the most appropriate and productive times in the
drug development process. Rather than submitting all data for review as
part of a complete application, we have found that the submission of
data supporting discrete technical sections during the investigational
phase of the new animal drug is the most appropriate and productive.
This ``phased review'' of data submissions has created efficiencies for
both us and the animal pharmaceutical industry.
Finally, Sec. 558.5(i) of our regulations (21 CFR 558.5(i))
describes the procedure for requesting a waiver of the labeling
requirements of Sec. 558.5(h) in the event that there is evidence to
indicate that it is unlikely a new animal drug would be used in the
manufacture of a liquid medicated feed.
The reporting associated with NADAs and related submissions is
necessary to ensure that new animal drugs are in compliance with
section 512(b)(1) of the FD&C Act. We use the information collected to
review the data, labeling and manufacturing controls and procedures to
evaluate the safety and effectiveness of the proposed new animal drug.
We estimate the burden of this collection of information as
follows:

Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of
21 CFR Section; activity Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
----------------------------------------------------------------------------------------------------------------
514.1 & 514.6; applications and 182 .05 9 212 1,908
amended applications...........
514.1(b)(8) and 514.8(c)(1); 182 .10 19 90 1,710
evidence to establish safety
and effectiveness..............
514.5(b), (d), (f); requesting 182 .49 89 50 4,450
presubmission conferences......
514.8(b); manufacturing changes 182 1.40 255 35 8,925
to an approved application.....
514.8(c)(1); labeling and other 182 .05 10 71 710
changes to an approved
application....................
514.8(c)(2) & (3); labeling and 182 .43 79 20 1,580
other changes to an approved
application....................
514.11; submission of data, 182 .09 16 1 16
studies and other information..
558.5(i); requirements for 182 .01 1 5 5
liquid medicated feed..........
Form FDA 356V................... 182 2.92 531 5 2,655
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[[Page 10873]]

Total....................... .............. .............. 1009 .............. 21,959
----------------------------------------------------------------------------------------------------------------
\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 pre-approval safety evaluation.

Based on the number of sponsors subject to animal drug user fees,
we estimate an average of 182 annual respondents during the 5 fiscal
years, from October 1, 2010 through September 30, 2014, on which these
estimates were made. We use this estimate consistently throughout the
table and calculate the ``annual frequency per respondent'' by dividing
the total annual responses by the total number of respondents. We base
our estimates of the average burden per response on our experience with
NADAs and related submissions.

Dated: February 25, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-04575 Filed 3-1-16; 8:45 am]
BILLING CODE 4164-01-P

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