83_FR_48616 83 FR 48430 - Agency Information Collection Activities; Proposed Collection; Comment Request; Generic Drug User Fee Cover Sheet

83 FR 48430 - Agency Information Collection Activities; Proposed Collection; Comment Request; Generic Drug User Fee Cover Sheet

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 83, Issue 186 (September 25, 2018)

Page Range48430-48431
FR Document2018-20765

The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (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 collection of information using Form FDA 3794, entitled ``Generic Drug User Fee Cover Sheet.''

Federal Register, Volume 83 Issue 186 (Tuesday, September 25, 2018)
[Federal Register Volume 83, Number 186 (Tuesday, September 25, 2018)]
[Notices]
[Pages 48430-48431]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-20765]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-N-3404]


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

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
an opportunity for public comment on the proposed collection of certain 
information by the Agency. Under the Paperwork Reduction Act of 1995 
(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 collection of information using Form FDA 
3794, entitled ``Generic Drug User Fee Cover Sheet.''

DATES: Submit either electronic or written comments on the collection 
of information by November 26, 2018.

ADDRESSES: You may submit comments as follows. Please note that late, 
untimely filed comments will not be considered. Electronic comments 
must be submitted on or before November 26, 2018. The https://www.regulations.gov electronic filing system will accept comments until 
11:59 p.m. Eastern Time at the end of November 26, 2018. Comments 
received by mail/hand delivery/courier (for written/paper submissions) 
will be considered timely if they are postmarked or the delivery 
service acceptance receipt is on or before that date.

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): Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets 
Management Staff, 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-2018-N-3404 for ``Agency Information Collection Activities; 
Proposed Collection; Comment Request; Generic Drug User Fee Cover 
Sheet.'' Received comments, those filed in a timely manner (see 
ADDRESSES), will be placed in the docket and, except for those 
submitted as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff 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

[[Page 48431]]

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 Dockets Management Staff. 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.thefederalregister.org/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    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 Dockets Management Staff, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: JonnaLynn Capezzuto, Office of 
Operations, Food and Drug Administration, Three White Flint North, 10A-
12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-3794, 
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.

Generic Drug User Fee Coversheet

OMB Control Number 0910-0727--Extension

    On July 9, 2012, the President signed the Generic Drug User Fee 
Amendments (GDUFA) (Pub. L. 112-144, Title 111) into law. GDUFA is 
designed to speed the delivery of safe and effective generic drugs to 
the public and reduce costs to the industry. Section 744B of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379f, et seq.), as 
added by GDUFA, authorized FDA to assess and collect the fees related 
to generic drugs, beginning fiscal year (FY) 2013 and expiring at the 
close of FY 2017, on September 30, 2017. GDUFA was reauthorized on 
August 18, 2017 (GDUFA II) and is effective beginning October 1, 2017, 
through September 30, 2022. GDUFA II enables FDA to assess industry 
user fees to bring greater predictability and timeliness to the review 
of generic drug applications.
    Form FDA 3794, the Generic Drug User Fee Cover Sheet available at 
https://www.ipqpubs.com/wp-content/uploads/2012/09/GDUFA-cover-sheet.pdf, requests the minimum necessary information from applicants 
to account for and track user fees and to determine the amount of the 
fee required. Applicants complete the cover sheets to accompany 
payments. While applicants may submit payment through multiple means, 
all cover sheets are prepared using FDA's web-based electronic User Fee 
System. Upon submitting the completed cover sheet, the User Fee System 
generates a user fee identification number, which is provided to 
applicants at the bottom of the cover sheet. It also notes the correct 
FY user fee assessment that is due for the submission/program. FDA 
requests that applicants submit a copy of this completed cover sheet 
along with the abbreviated new drug application, and other GDUFA fees, 
so FDA can verify that the applicant has paid the correct user fee.
    Respondents to this proposed collection of information would be 
potential or actual generic drug application holders or related Active 
Pharmaceutical Ingredient and Finished Dosage Form manufacturers. 
Companies with multiple user fee obligations will submit a cover sheet 
for each user fee obligation.
    FDA estimates the burden of this collection of information as 
follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                 Number of
                    Form                         Number of     responses per   Total annual           Average burden per response           Total hours
                                                respondents     respondent       responses
--------------------------------------------------------------------------------------------------------------------------------------------------------
FDA 3794....................................             500           7.616           3,808  0.5 (30 minutes)..........................           1,904
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    The estimated burden for the information collection reflects an 
increase since last OMB approval. This adjustment corresponds with an 
increase in submissions received by the Agency.

    Dated: September 19, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-20765 Filed 9-24-18; 8:45 am]
 BILLING CODE 4164-01-P



                                               48430                           Federal Register / Vol. 83, No. 186 / Tuesday, September 25, 2018 / Notices

                                                                                                       BACKGROUND AND BRIEF DESCRIPTION—Continued
                                                                                                                                                                                                           Average
                                                                                                                                                                                           Number of
                                                                                                                                                                        Number of                        burden per
                                                           Type of respondent                                                 Form name                                                  responses per
                                                                                                                                                                       respondents                        response
                                                                                                                                                                                           respondent     (in hours)

                                               Responder (FDNY and General Re-                        Decertification Letter and Appeal Notification—                                5               1            1.5
                                                 sponder)/Survivor.                                     Health Condition.
                                               Responder (FDNY and General Re-                        Denial Letter and Appeal Notification—Health Condi-                        60                  1            1.5
                                                 sponder)/Survivor.                                     tion Certification.
                                               Responder (FDNY and General Re-                        Denial Letter and Appeal Notification—Treatment                            26                  1            1.5
                                                 sponder)/Survivor.                                     Authorization.
                                               Responder (FDNY and General Re-                        WTC Health Program Medical Travel Refund Re-                               10                  1          10/60
                                                 sponder)/Survivor.                                     quest.
                                               Program Members ..............................         Designated Representative Form ...............................             30                  1          15/60
                                               Program Member ...............................         HIPAA Release Form to allow the sharing of mem-                            30                  1          15/60
                                                                                                        ber information with a third party.
                                               Pharmacy ...........................................   Outpatient prescription pharmaceuticals ....................             150                261            1/60
                                               Program Medical Provider ..................            Reimbursement Denial Letter and Appeal Notifica-                         600                  1           30/60
                                                                                                        tion—Providers.
                                               Responder/Survivor/Advocate (physi-                    Petition for the addition of health conditions ..............              60                  1                 1
                                                 cian).



                                               Jeffrey M. Zirger,                                               ADDRESSES:   You may submit comments                    manner detailed (see ‘‘Written/Paper
                                               Acting Chief, Information Collection Review                      as follows. Please note that late,                      Submissions’’ and ‘‘Instructions’’).
                                               Office, Office of Scientific Integrity, Office                   untimely filed comments will not be
                                               of the Associate Director for Science, Office                                                                            Written/Paper Submissions
                                                                                                                considered. Electronic comments must
                                               of the Director, Centers for Disease Control                     be submitted on or before November 26,                     Submit written/paper submissions as
                                               and Prevention.                                                  2018. The https://www.regulations.gov                   follows:
                                               [FR Doc. 2018–20807 Filed 9–24–18; 8:45 am]                      electronic filing system will accept                       • Mail/Hand Delivery/Courier (for
                                               BILLING CODE 4163–18–P                                           comments until 11:59 p.m. Eastern Time                  written/paper submissions): Dockets
                                                                                                                at the end of November 26, 2018.                        Management Staff (HFA–305), Food and
                                                                                                                Comments received by mail/hand                          Drug Administration, 5630 Fishers
                                               DEPARTMENT OF HEALTH AND                                         delivery/courier (for written/paper                     Lane, Rm. 1061, Rockville, MD 20852.
                                               HUMAN SERVICES                                                   submissions) will be considered timely                     • For written/paper comments
                                                                                                                if they are postmarked or the delivery                  submitted to the Dockets Management
                                               Food and Drug Administration                                                                                             Staff, FDA will post your comment, as
                                                                                                                service acceptance receipt is on or
                                               [Docket No. FDA–2018–N–3404]                                                                                             well as any attachments, except for
                                                                                                                before that date.
                                                                                                                                                                        information submitted, marked and
                                               Agency Information Collection                                    Electronic Submissions                                  identified, as confidential, if submitted
                                               Activities; Proposed Collection;                                                                                         as detailed in ‘‘Instructions.’’
                                                                                                                  Submit electronic comments in the                        Instructions: All submissions received
                                               Comment Request; Generic Drug User                               following way:
                                               Fee Cover Sheet                                                                                                          must include the Docket No. FDA–
                                                                                                                  • Federal eRulemaking Portal:                         2018–N–3404 for ‘‘Agency Information
                                               AGENCY:      Food and Drug Administration,                       https://www.regulations.gov. Follow the                 Collection Activities; Proposed
                                               HHS.                                                             instructions for submitting comments.                   Collection; Comment Request; Generic
                                               ACTION:     Notice.                                              Comments submitted electronically,                      Drug User Fee Cover Sheet.’’ Received
                                                                                                                including attachments, to https://                      comments, those filed in a timely
                                               SUMMARY:   The Food and Drug                                     www.regulations.gov will be posted to                   manner (see ADDRESSES), will be placed
                                               Administration (FDA or Agency) is                                the docket unchanged. Because your                      in the docket and, except for those
                                               announcing an opportunity for public                             comment will be made public, you are                    submitted as ‘‘Confidential
                                               comment on the proposed collection of                            solely responsible for ensuring that your               Submissions,’’ publicly viewable at
                                               certain information by the Agency.                               comment does not include any                            https://www.regulations.gov or at the
                                               Under the Paperwork Reduction Act of                             confidential information that you or a                  Dockets Management Staff between 9
                                               1995 (PRA), Federal Agencies are                                 third party may not wish to be posted,                  a.m. and 4 p.m., Monday through
                                               required to publish notice in the                                such as medical information, your or                    Friday.
                                               Federal Register concerning each                                 anyone else’s Social Security number, or                   • Confidential Submissions—To
                                               proposed collection of information,                              confidential business information, such                 submit a comment with confidential
                                               including each proposed extension of an                          as a manufacturing process. Please note                 information that you do not wish to be
                                               existing collection of information, and                          that if you include your name, contact                  made publicly available, submit your
                                               to allow 60 days for public comment in                           information, or other information that                  comments only as a written/paper
                                               response to the notice. This notice                              identifies you in the body of your                      submission. You should submit two
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                                               solicits comments on collection of                               comments, that information will be                      copies total. One copy will include the
                                               information using Form FDA 3794,                                 posted on https://www.regulations.gov.                  information you claim to be confidential
                                               entitled ‘‘Generic Drug User Fee Cover                             • If you want to submit a comment                     with a heading or cover note that states
                                               Sheet.’’                                                         with confidential information that you                  ‘‘THIS DOCUMENT CONTAINS
                                               DATES: Submit either electronic or                               do not wish to be made available to the                 CONFIDENTIAL INFORMATION.’’ The
                                               written comments on the collection of                            public, submit the comment as a                         Agency will review this copy, including
                                               information by November 26, 2018.                                written/paper submission and in the                     the claimed confidential information, in


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                                                                                 Federal Register / Vol. 83, No. 186 / Tuesday, September 25, 2018 / Notices                                                         48431

                                               its consideration of comments. The                                    or requirements that members of the                    collect the fees related to generic drugs,
                                               second copy, which will have the                                      public submit reports, keep records, or                beginning fiscal year (FY) 2013 and
                                               claimed confidential information                                      provide information to a third party.                  expiring at the close of FY 2017, on
                                               redacted/blacked out, will be available                               Section 3506(c)(2)(A) of the PRA (44                   September 30, 2017. GDUFA was
                                               for public viewing and posted on                                      U.S.C. 3506(c)(2)(A)) requires Federal                 reauthorized on August 18, 2017
                                               https://www.regulations.gov. Submit                                   Agencies to provide a 60-day notice in                 (GDUFA II) and is effective beginning
                                               both copies to the Dockets Management                                 the Federal Register concerning each                   October 1, 2017, through September 30,
                                               Staff. If you do not wish your name and                               proposed collection of information,                    2022. GDUFA II enables FDA to assess
                                               contact information to be made publicly                               including each proposed extension of an                industry user fees to bring greater
                                               available, you can provide this                                       existing collection of information,                    predictability and timeliness to the
                                               information on the cover sheet and not                                before submitting the collection to OMB                review of generic drug applications.
                                               in the body of your comments and you                                  for approval. To comply with this                        Form FDA 3794, the Generic Drug
                                               must identify this information as                                     requirement, FDA is publishing notice                  User Fee Cover Sheet available at
                                               ‘‘confidential.’’ Any information marked                              of the proposed collection of                          https://www.ipqpubs.com/wp-content/
                                               as ‘‘confidential’’ will not be disclosed                             information set forth in this document.                uploads/2012/09/GDUFA-cover-
                                               except in accordance with 21 CFR 10.20                                   With respect to the following                       sheet.pdf, requests the minimum
                                               and other applicable disclosure law. For                              collection of information, FDA invites                 necessary information from applicants
                                               more information about FDA’s posting                                  comments on these topics: (1) Whether                  to account for and track user fees and to
                                               of comments to public dockets, see 80                                 the proposed collection of information                 determine the amount of the fee
                                               FR 56469, September 18, 2015, or access                               is necessary for the proper performance                required. Applicants complete the cover
                                               the information at: https://www.gpo.gov/                              of FDA’s functions, including whether                  sheets to accompany payments. While
                                               fdsys/pkg/FR-2015-09-18/pdf/2015-                                     the information will have practical                    applicants may submit payment through
                                               23389.pdf.                                                            utility; (2) the accuracy of FDA’s                     multiple means, all cover sheets are
                                                  Docket: For access to the docket to                                estimate of the burden of the proposed                 prepared using FDA’s web-based
                                               read background documents or the
                                                                                                                     collection of information, including the               electronic User Fee System. Upon
                                               electronic and written/paper comments
                                                                                                                     validity of the methodology and                        submitting the completed cover sheet,
                                               received, go to https://
                                                                                                                     assumptions used; (3) ways to enhance                  the User Fee System generates a user fee
                                               www.regulations.gov and insert the
                                                                                                                     the quality, utility, and clarity of the               identification number, which is
                                               docket number, found in brackets in the
                                                                                                                     information to be collected; and (4)                   provided to applicants at the bottom of
                                               heading of this document, into the
                                                                                                                     ways to minimize the burden of the                     the cover sheet. It also notes the correct
                                               ‘‘Search’’ box and follow the prompts
                                                                                                                     collection of information on                           FY user fee assessment that is due for
                                               and/or go to the Dockets Management
                                                                                                                     respondents, including through the use                 the submission/program. FDA requests
                                               Staff, 5630 Fishers Lane, Rm. 1061,
                                                                                                                     of automated collection techniques,                    that applicants submit a copy of this
                                               Rockville, MD 20852.
                                                                                                                     when appropriate, and other forms of                   completed cover sheet along with the
                                               FOR FURTHER INFORMATION CONTACT:
                                                                                                                     information technology.                                abbreviated new drug application, and
                                               JonnaLynn Capezzuto, Office of
                                                                                                                     Generic Drug User Fee Coversheet                       other GDUFA fees, so FDA can verify
                                               Operations, Food and Drug
                                                                                                                                                                            that the applicant has paid the correct
                                               Administration, Three White Flint
                                                                                                                     OMB Control Number 0910–0727—                          user fee.
                                               North, 10A–12M, 11601 Landsdown St.,
                                                                                                                     Extension                                                Respondents to this proposed
                                               North Bethesda, MD 20852, 301–796–
                                               3794, PRAStaff@fda.hhs.gov.                                             On July 9, 2012, the President signed                collection of information would be
                                               SUPPLEMENTARY INFORMATION: Under the                                  the Generic Drug User Fee Amendments                   potential or actual generic drug
                                               PRA (44 U.S.C. 3501–3520), Federal                                    (GDUFA) (Pub. L. 112–144, Title 111)                   application holders or related Active
                                               Agencies must obtain approval from the                                into law. GDUFA is designed to speed                   Pharmaceutical Ingredient and Finished
                                               Office of Management and Budget                                       the delivery of safe and effective generic             Dosage Form manufacturers. Companies
                                               (OMB) for each collection of                                          drugs to the public and reduce costs to                with multiple user fee obligations will
                                               information they conduct or sponsor.                                  the industry. Section 744B of the                      submit a cover sheet for each user fee
                                               ‘‘Collection of information’’ is defined                              Federal Food, Drug, and Cosmetic Act                   obligation.
                                               in 44 U.S.C. 3502(3) and 5 CFR                                        (21 U.S.C. 379f, et seq.), as added by                   FDA estimates the burden of this
                                               1320.3(c) and includes Agency requests                                GDUFA, authorized FDA to assess and                    collection of information as follows:

                                                                                                          TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
                                                                                                                                                Number of
                                                                                                                              Number of                            Total annual         Average burden
                                                                                Form                                                          responses per                                                      Total hours
                                                                                                                             respondents                            responses            per response
                                                                                                                                                respondent

                                               FDA 3794 .................................................................               500              7.616             3,808     0.5 (30 minutes) ........            1,904
                                                  1 There    are no capital costs or operating and maintenance costs associated with this collection of information.


                                                 The estimated burden for the                                        increase in submissions received by the                  Dated: September 19, 2018.
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                                               information collection reflects an                                    Agency.                                                Leslie Kux,
                                               increase since last OMB approval. This                                                                                       Associate Commissioner for Policy.
                                               adjustment corresponds with an                                                                                               [FR Doc. 2018–20765 Filed 9–24–18; 8:45 am]
                                                                                                                                                                            BILLING CODE 4164–01–P




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Document Created: 2018-09-25 00:22:34
Document Modified: 2018-09-25 00:22:34
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 26, 2018.
ContactJonnaLynn Capezzuto, Office of Operations, Food and Drug Administration, Three White Flint North, 10A- 12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-3794, [email protected]
FR Citation83 FR 48430 

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