81_FR_60878 81 FR 60707 - Agency Information Collection Activities; Proposed Collection; Comment Request; Animal Generic Drug User Fee Act Cover Sheet

81 FR 60707 - Agency Information Collection Activities; Proposed Collection; Comment Request; Animal Generic Drug User Fee Act Cover Sheet

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 81, Issue 171 (September 2, 2016)

Page Range60707-60708
FR Document2016-21177

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 the information collection requirements of the Animal Generic Drug User Fee Act (AGDUFA) cover sheet.

Federal Register, Volume 81 Issue 171 (Friday, September 2, 2016) 
[Federal Register Volume 81, Number 171 (Friday, September 2, 2016)]
[Notices]
[Pages 60707-60708]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-21177]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0655]


Agency Information Collection Activities; Proposed Collection; 
Comment Request; Animal Generic Drug User Fee Act Cover Sheet

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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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 the information collection 
requirements of the Animal Generic Drug User Fee Act (AGDUFA) cover 
sheet.

DATES: Submit either electronic or written comments on the collection 
of information by November 1, 2016.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to http://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 http://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 submission): 
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-2011-N-0655 for ``Animal Generic Drug User Fee Act Cover Sheet.'' 
Received comments will be placed in the docket and, except for those 
submitted as ``Confidential Submissions,'' publicly viewable at http://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

[[Page 60708]]

claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on http://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: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to http://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, Three White Flint North, 10A63, 11601 
Landsdown St., North Bethesda, MD 20852, [email protected].

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.

Form FDA 3728, Animal Generic User Fee Act Cover Sheet--21 U.S.C. 379j-
21 OMB Control Number 0910-0632--Extension

    Section 741 of the Federal Food, Drug, and Cosmetic Act (the FD&C 
Act) (21 U.S.C. 379j-21) establishes three different kinds of user 
fees: (1) Fees for certain types of abbreviated applications for 
generic new animal drugs; (2) annual fees for certain generic new 
animal drug products; and (3) annual fees for certain sponsors of 
abbreviated applications for generic new animal drugs and/or 
investigational submissions for generic new animal drugs (21 U.S.C. 
379j-21(a)). Because concurrent submission of user fees with 
applications is required, the review of an application cannot begin 
until the fee is submitted. Form FDA 3728 is the AGDUFA Cover Sheet, 
which is designed to provide the minimum necessary information to 
determine whether a fee is required for review of an application, to 
determine the amount of the fee required, and to account for and track 
user fees.
    FDA estimates the burden of this collection of information as 
follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                         Number of
                            Form FDA No.                                Number of      responses per     Total annual    Average burden    Total hours
                                                                       respondents       respondent       responses       per response
--------------------------------------------------------------------------------------------------------------------------------------------------------
3728...............................................................              20                2               40     .08 (5 min.)              3.2
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information

    Respondents to this collection of information are generic animal 
drug applicants. Based on FDA's data base system, there are an 
estimated 20 sponsors of new animal drugs potentially subject to 
AGDUFA.

    Dated: August 29, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-21177 Filed 9-1-16; 8:45 am]
BILLING CODE 4164-01-P

Federal Register / Vol. 81, No. 171 / Friday, September 2, 2016 / Notices 60707 BSE. This regulation places general protein derived from mammalian tissue changes to an applicable procedure or requirements on persons that from all other protein products from the process the record must be updated. manufacture, blend, process, and time of receipt until the time of Written procedures required by this distribute products that contain, or may shipment. These written procedures are section shall be made available for contain, protein derived from intended to help the firm formalize their inspection and copying by FDA. mammalian tissue, and feeds made from processes, and then to help inspection In the Federal Register of March 15, such products. personnel confirm that the firm is Specifically, this regulation requires operating in compliance with the 2016 (81 FR 13803), FDA published a renderers, feed manufacturers, and regulation. Inspection personnel will 60-day notice requesting public others involved in feed and feed evaluate the written procedure and comment on the proposed collection of ingredient manufacturing and confirm it is being followed when they information. FDA received one distribution to maintain written are conducting an inspection. comment; however, it did not pertain to procedures specifying the cleanout These written procedures must be the information collection. procedures or other means, and maintained as long as the facility is FDA estimates the burden of this specifying the procedures for separating operating in a manner that necessitates collection of information as follows: products that contain or may contain the record, and if the facility makes TABLE 1—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1 Number of Total Average Number of Total 21 CFR Section records per annual burden per recordkeepers hours recordkeeper records recordkeeping 589.2000(e)(1)(iv); written procedures ................................ 320 1 320 14 4,480 1 There are no capital costs or operating and maintenance costs associated with this collection of information. We base our estimate of the number notice. This notice solicits comments on Written/Paper Submissions of recordkeepers on inspectional data, the information collection requirements Submit written/paper submissions as which reflect a decline in the number of of the Animal Generic Drug User Fee follows: recordkeepers. We attribute this decline Act (AGDUFA) cover sheet. • Mail/Hand delivery/Courier (for to a reduction in the number of firms DATES: Submit either electronic or written/paper submission): Division of handling animal protein for use in written comments on the collection of Dockets Management (HFA–305), Food animal feed. information by November 1, 2016. and Drug Administration, 5630 Fishers Dated: August 29, 2016. Lane, Rm. 1061, Rockville, MD 20852. ADDRESSES: You may submit comments Leslie Kux, • For written/paper comments as follows: Associate Commissioner for Policy. submitted to the Division of Dockets [FR Doc. 2016–21157 Filed 9–1–16; 8:45 am] Electronic Submissions Management, FDA will post your comment, as well as any attachments, BILLING CODE 4164–01–P Submit electronic comments in the except for information submitted, following way: marked and identified, as confidential, • Federal eRulemaking Portal: http:// if submitted as detailed in DEPARTMENT OF HEALTH AND www.regulations.gov. Follow the ‘‘Instructions.’’ HUMAN SERVICES instructions for submitting comments. Instructions: All submissions received Food and Drug Administration Comments submitted electronically, must include the Docket No. FDA– including attachments, to http:// 2011–N–0655 for ‘‘Animal Generic Drug [Docket No. FDA–2011–N–0655] www.regulations.gov will be posted to User Fee Act Cover Sheet.’’ Received the docket unchanged. Because your comments will be placed in the docket Agency Information Collection comment will be made public, you are Activities; Proposed Collection; and, except for those submitted as solely responsible for ensuring that your ‘‘Confidential Submissions,’’ publicly Comment Request; Animal Generic comment does not include any Drug User Fee Act Cover Sheet viewable at http://www.regulations.gov confidential information that you or a or at the Division of Dockets AGENCY: Food and Drug Administration, third party may not wish to be posted, Management between 9 a.m. and 4 p.m., HHS. such as medical information, your or Monday through Friday. ACTION: Notice. anyone else’s Social Security number, or • Confidential Submissions—To confidential business information, such submit a comment with confidential SUMMARY: The Food and Drug as a manufacturing process. Please note information that you do not wish to be Administration (FDA) is announcing an that if you include your name, contact made publicly available, submit your opportunity for public comment on the information, or other information that comments only as a written/paper proposed collection of certain identifies you in the body of your submission. You should submit two information by the Agency. Under the comments, that information will be copies total. One copy will include the Paperwork Reduction Act of 1995 (the posted on http://www.regulations.gov. information you claim to be confidential mstockstill on DSK3G9T082PROD with NOTICES PRA), Federal Agencies are required to • If you want to submit a comment with a heading or cover note that states publish notice in the Federal Register with confidential information that you ‘‘THIS DOCUMENT CONTAINS concerning each proposed collection of do not wish to be made available to the CONFIDENTIAL INFORMATION.’’ The information, including each proposed public, submit the comment as a Agency will review this copy, including extension of an existing collection of written/paper submission and in the the claimed confidential information, in information, and to allow 60 days for manner detailed (see ‘‘Written/Paper its consideration of comments. The public comment in response to the Submissions’’ and ‘‘Instructions’’). second copy, which will have the VerDate Sep<11>2014 18:25 Sep 01, 2016 Jkt 238001 PO 00000 Frm 00039 Fmt 4703 Sfmt 4703 E:\FR\FM\02SEN1.SGM 02SEN1

60708 Federal Register / Vol. 81, No. 171 / Friday, September 2, 2016 / Notices claimed confidential information St., North Bethesda, MD 20852, the quality, utility, and clarity of the redacted/blacked out, will be available PRAStaff@fda.hhs.gov. information to be collected; and (4) for public viewing and posted on http:// SUPPLEMENTARY INFORMATION: Under the ways to minimize the burden of the www.regulations.gov. Submit both PRA (44 U.S.C. 3501–3520), Federal collection of information on copies to the Division of Dockets Agencies must obtain approval from the respondents, including through the use Management. If you do not wish your Office of Management and Budget of automated collection techniques, name and contact information to be (OMB) for each collection of when appropriate, and other forms of made publicly available, you can information they conduct or sponsor. information technology. provide this information on the cover ‘‘Collection of information’’ is defined Form FDA 3728, Animal Generic User sheet and not in the body of your in 44 U.S.C. 3502(3) and 5 CFR Fee Act Cover Sheet—21 U.S.C. 379j–21 comments and you must identify this 1320.3(c) and includes Agency requests OMB Control Number 0910–0632— information as ‘‘confidential.’’ Any or requirements that members of the Extension information marked as ‘‘confidential’’ public submit reports, keep records, or will not be disclosed except in provide information to a third party. Section 741 of the Federal Food, Drug, accordance with 21 CFR 10.20 and other Section 3506(c)(2)(A) of the PRA (44 and Cosmetic Act (the FD&C Act) (21 applicable disclosure law. For more U.S.C. 3506(c)(2)(A)) requires Federal U.S.C. 379j–21) establishes three information about FDA’s posting of Agencies to provide a 60-day notice in different kinds of user fees: (1) Fees for comments to public dockets, see 80 FR the Federal Register concerning each certain types of abbreviated applications 56469, September 18, 2015, or access proposed collection of information, for generic new animal drugs; (2) annual the information at: http://www.fda.gov/ including each proposed extension of an fees for certain generic new animal drug regulatoryinformation/dockets/ existing collection of information,] products; and (3) annual fees for certain default.htm. before submitting the collection to OMB sponsors of abbreviated applications for for approval. To comply with this generic new animal drugs and/or Docket: For access to the docket to requirement, FDA is publishing notice investigational submissions for generic read background documents or the of the proposed collection of new animal drugs (21 U.S.C. 379j– electronic and written/paper comments information set forth in this document. 21(a)). Because concurrent submission received, go to http:// With respect to the following of user fees with applications is www.regulations.gov and insert the collection of information, FDA invites required, the review of an application docket number, found in brackets in the comments on these topics: (1) Whether cannot begin until the fee is submitted. heading of this document, into the the proposed collection of information Form FDA 3728 is the AGDUFA Cover ‘‘Search’’ box and follow the prompts is necessary for the proper performance Sheet, which is designed to provide the and/or go to the Division of Dockets of FDA’s functions, including whether minimum necessary information to Management, 5630 Fishers Lane, Rm. the information will have practical determine whether a fee is required for 1061, Rockville, MD 20852. utility; (2) the accuracy of FDA’s review of an application, to determine FOR FURTHER INFORMATION CONTACT: FDA estimate of the burden of the proposed the amount of the fee required, and to PRA Staff, Office of Operations, Food collection of information, including the account for and track user fees. and Drug Administration, Three White validity of the methodology and FDA estimates the burden of this Flint North, 10A63, 11601 Landsdown assumptions used; (3) ways to enhance collection of information as follows: TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1 Number of Average Number of Total annual Total Form FDA No. responses per burden per respondents responses hours respondent response 3728 ..................................................................................... 20 2 40 .08 (5 min.) 3.2 1 There are no capital costs or operating and maintenance costs associated with this collection of information Respondents to this collection of DEPARTMENT OF HEALTH AND review and approval. Comments information are generic animal drug HUMAN SERVICES submitted during the first public review applicants. Based on FDA’s data base of this ICR will be provided to OMB. system, there are an estimated 20 Health Resources and Services OMB will accept further comments from sponsors of new animal drugs Administration the public during the review and potentially subject to AGDUFA. approval period. Agency Information Collection Dated: August 29, 2016. Activities: Submission to OMB for DATES: Comments on this ICR should be Leslie Kux, Review and Approval; Public Comment received within 30 days of this notice. Associate Commissioner for Policy. Request; Countermeasures Injury ADDRESSES: Submit your comments, [FR Doc. 2016–21177 Filed 9–1–16; 8:45 am] Compensation Program including the ICR Title, to the desk officer for HRSA, either by email to BILLING CODE 4164–01–P AGENCY: Health Resources and Services OIRA_submission@omb.eop.gov or by mstockstill on DSK3G9T082PROD with NOTICES Administration, HHS. fax to 202–395–5806. ACTION: Notice. FOR FURTHER INFORMATION CONTACT: To SUMMARY: In compliance with the request a copy of the clearance requests Paperwork Reduction Act of 1995, submitted to OMB for review, email the HRSA has submitted an Information HRSA Information Collection Clearance Collection Request (ICR) to the Office of Officer at paperwork@hrsa.gov or call Management and Budget (OMB) for (301) 443–1984. VerDate Sep<11>2014 18:25 Sep 01, 2016 Jkt 238001 PO 00000 Frm 00040 Fmt 4703 Sfmt 4703 E:\FR\FM\02SEN1.SGM 02SEN1


Document Created: 2018-02-09 11:55:25
Document Modified: 2018-02-09 11:55:25
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice.
DatesSubmit either electronic or written comments on the collection of information by November 1, 2016.
ContactFDA PRA Staff, Office of Operations, Food and Drug Administration, Three White Flint North, 10A63, 11601 Landsdown St., North Bethesda, MD 20852, [email protected]
FR Citation81 FR 60707 
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