[Federal Register Volume 83, Number 186 (Tuesday, September 25, 2018)]
[Notices]
[Pages 48430-48431]
[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.

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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

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.gpo.gov/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,<PHONE_NUMBER>,
[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.

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\
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                                                                 Number of
                    Form                         Number of     responses per   Total annual           Average burden per response           Total hours
                                                respondents     respondent       responses
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FDA 3794....................................             500           7.616           3,808  0.5 (30 minutes)..........................           1,904
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\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]
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[Federal Register Volume 76, Number 210 (Monday, October 31, 2011)]
[Notices]
[Page 67173]
[FR Doc No: 2011-28098]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project Nos. 14158-000; 14191-000]

Arkansas Electric Cooperative Corp.; FFP Project 1 LLC; Notice of
Competing Preliminary Permit Applications Accepted for Filing and
Soliciting Comments, Motions To Intervene, and Competing Applications

    On May 2, 2011, Arkansas Electric Cooperative Corp. (Arkansas
Electric), and on May 3, 2011, FFP Project 1 LLC (FFP 1) filed
preliminary permit applications, pursuant to section 4(f) of the
Federal Power Act, proposing to study the feasibility of a hydropower
project at the U.S. Army Corps of Engineers' (Corps) Col. Charles D.
Maynard Lock & Dam, located on the Arkansas River in Jefferson County,
Arkansas. The sole purpose of a preliminary permit, if issued, is to
grant the permit holder priority to file a license application during
the permit term. A preliminary permit does not authorize the permit
holder to perform any land-disturbing activities or otherwise enter
upon lands or waters owned by others without the owners' express
permission.
    Arkansas Electric's Project No. 14158-000 would consist of: (1) An
750-foot-long, 400-foot-wide headrace channel; (2) a powerhouse,
located on the right abutment of the dam, containing four generating
units with a total capacity of 36.0 megawatt (MW); (3) a 1,200-foot-
long, 450-foot-wide tailrace; and (4) a proposed 4.0-mile-long, 115
kilo-volt (kV) transmission line to an existing switchyard. The
proposed project would have an average annual generation of 140.0 GWh,
and operate run-of-river utilizing surplus water from the Col. Charles
D. Maynard Lock & Dam, as directed by the Corps.
    Applicant Contact: Mr. Jonathan Oliver, Arkansas Electric
Cooperative Corp., One Cooperative Way, Little Rock, AR 72209. (501)
570-2488.
    FFP 1's Project No. 14191-000 would consist of: (1) An 500-foot-
long, 450-foot-wide approach channel; (2) a powerhouse, located on the
west side of the dam, containing four generating units with a total
capacity of 42.0 MW; (3) a 1,785-foot-long, 315-foot-wide tailrace; (4)
a 7.2/115 KV substation; and (5) a 2.0-mile-long, 115 kV transmission
line. The proposed project would have an average annual generation of
168.0 GWh, and operate run-of-river utilizing surplus water from the
Col. Charles D. Maynard Lock & Dam, as directed by the Corps.
    Applicant Contact: Ms. Ramya Swaminathan, Free Flow Power Corp.,
239 Causeway Street, Suite 300, Boston, MA 02114.<PHONE_NUMBER>.
    FERC Contact: Michael Spencer<EMAIL_ADDRESS>(202) 502-
6093.
    Deadline for filing comments, motions to intervene, competing
applications (without notices of intent), or notices of intent to file
competing applications: 60 days from the issuance of this notice.
Competing applications and notices of intent must meet the requirements
of 18 CFR 4.36. Comments, motions to intervene, notices of intent, and
competing applications may be filed electronically via the Internet.
See 18 CFR 385.2001(a)(1)(iii) and the instructions on the Commission's
Web site http://www.ferc.gov/docs-filing/efiling.asp. Commenters can
submit brief comments up to 6,000 characters, without prior
registration, using the eComment system at http://www.ferc.gov/docs-filing/ecomment.asp. You must include your name and contact information
at the end of your comments. For assistance, please contact FERC Online
Support. Although the Commission strongly encourages electronic filing,
documents may also be paper-filed. To paper-file, mail an original and
seven copies to: Kimberly D. Bose, Secretary, Federal Energy Regulatory
Commission, 888 First Street, NE., Washington, DC 20426.
    More information about this project, including a copy of the
application, can be viewed or printed on the ``eLibrary'' link of the
Commission's Web site at http://www.ferc.gov/docs-filing/elibrary.asp.
Enter the docket number (P-14158-000, or P-14191-000) in the docket
number field to access the document. For assistance, contact FERC
Online Support.

    Dated: October 25, 2011.
Kimberly D. Bose,
Secretary.
[FR Doc. 2011-28098 Filed 10-28-11; 8:45 am]
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[Federal Register: September 7, 2010 (Volume 75, Number 172)]
[Notices]
[Page 54337-54338]
[DOCID:fr07se10-25]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2009-0886; FRL-9196-6]

Agency Information Collection Activities; Submission to OMB for
Review and Approval; Comment Request; Submission of Unreasonable
Adverse Effects Information Under FIFRA Section 6(a)(2); EPA ICR No.
1204.11, OMB Control No. 2070-0039

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: In compliance with the Paperwork Reduction Act (PRA)(44 U.S.C.
3501 et seq.), this document announces that an Information Collection
Request (ICR) has been forwarded to the Office of Management and Budget
(OMB) for review and approval. This is a request to renew an existing
approved collection. The ICR, which is abstracted below, describes the
nature of the information collection and its estimated burden and cost.

DATES: Additional comments may be submitted on or before October 7,
2010.

ADDRESSES: Submit your comments, referencing Docket ID No. EPA-HQ-OPP-
2009-0886, to (1) EPA online using http://www.regulations.gov (our
preferred method), or by mail to: EPA Docket Center, Environmental
Protection Agency, Pesticide Public Regulatory Docket at Potomac Yard,
7502P, 1200 Pennsylvania Ave., NW., Washington, DC 20460, and (2) OMB
by mail to: Office of Information and Regulatory Affairs, Office of
Management and Budget (OMB), Attention: Desk Officer for EPA, 725 17th
Street, NW., Washington, DC 20503.

FOR FURTHER INFORMATION CONTACT: Cameo G. Smoot, Field and External
Affairs Division, Office of Pesticide Programs, 7506P, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460;
telephone number:<PHONE_NUMBER>; fax number:<PHONE_NUMBER>; e-mail
address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: EPA has submitted the following ICR to OMB
for review and approval according to the Paperwork Reduction Act
(PRA)(44 U.S.C. 3501 et seq.), and procedures prescribed in 5 CFR
1320.12. On February 24, 2010, EPA sought comments on the renewal ICR,
(75 FR 8336), pursuant to 5 CFR 1320.8(d). EPA received no comments
during the comment period. Any additional comments on this ICR should
be submitted to EPA and OMB within 30 days of this notice.
    EPA has established a public docket for this ICR under Docket ID
No. EPA-OPP-2009-0886, which is available for online viewing at http://
www.regulations.gov, or in person viewing at the Pesticides Public
Regulatory Docket, One Potomac Yard, 2777 S. Crystal Drive, Room S-4400
Arlington, VA, 22202. The Pesticide Public Reading Room is open from 8
a.m. to 4:00 p.m., Monday through Friday, excluding legal holidays. The
telephone number for the Reading Room is<PHONE_NUMBER>.
    Use EPA's electronic docket and comment system at http://
www.regulations.gov, to submit or view public comments, access the
index listing of the contents of the docket, and to access those
documents in the docket that are available electronically. Once in the
system, select ``docket search,'' then key in the docket ID number
identified above. Please note that EPA's policy is that public
comments, whether submitted electronically or in paper, will be made
available for public viewing at http://www.regulations.gov as EPA
receives them and without change, unless the comment contains
copyrighted material, confidential business information (CBI), or other
information whose public disclosure is restricted by statute. For
further information about the electronic docket, go to http://
www.regulations.gov.
    Title: Submission of Unreasonable Adverse Effects Information under
FIFRA Section 6(a)(2).
    ICR numbers: EPA ICR No. 1204.11, OMB Control No. 2070.0039.
    ICR Status: The current OMB approval for this ICR is scheduled to
expire on October 31, 2010. Under OMB regulations, the Agency may
continue to conduct or sponsor the collection of information while this
submission is

pending at OMB. This ICR is for an ongoing information collection
activity. 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. The OMB control numbers for EPA's
regulations in title 40 of the CFR, after appearing in the Final Rule
and in the Federal Register when approved, are listed in 40 CFR part 9
or by other appropriate means, such as on the related collection
instrument or form, if applicable.
    Abstract: Section 6(a)(2) of the Federal Insecticide, Fungicide and
Rodenticide Act (FIFRA), requires pesticide registrants to submit
information to the Agency which may be relevant to the balancing of the
risks and benefits of a pesticide product. The statute requires the
registrant to submit any factual information that it acquires regarding
adverse effects associated with its pesticidal products, and it is up
to the Agency to determine whether or not that factual information
constitutes an unreasonable adverse effect. In order to limit the
amount of less meaningful information that might be submitted to the
Agency, the EPA has limited the scope of factual information that the
registrant must submit. The agency's regulations at 40 CFR part 159
provide a detailed description of the reporting obligations of
registrants under FIFRA section 6(a)(2).
    Burden Statement: The annual public reporting and recordkeeping
burden for this collection of information is estimated to average about
117 hours per respondent. Burden means the total time, effort, or
financial resources expended by persons to generate, maintain, retain,
or disclose or provide information to or for a Federal agency. This
includes the time needed to review instructions; develop, acquire,
install, and utilize technology and systems for the purposes of
collecting, validating, and verifying information, processing and
maintaining information, and disclosing and providing information;
adjust the existing ways to comply with any previously applicable
instructions and requirements which have subsequently changed; train
personnel to be able to respond to a collection of information; search
data sources; complete and review the collection of information; and
transmit or otherwise disclose the information.
    Respondents/Affected Entities: Pesticide Registrants.
    Estimated Total Number of Respondents: 1733.
    Frequency of Response: As necessary.
    Estimated Total Annual Hour Burden: 203,236.
    Estimated Total Annual Cost: $11,793,027.
    Changes in the Estimates: There is an increase of 35,920 hours in
the total estimated burden currently identified in the OMB Inventory of
Approved ICR Burdens. This adjustment reflects the increase of the
number of registrants of active products (1,733 versus 1,720) and an
increase in the estimated burden to account for additional employees
being trained.

    Dated: August 27, 2010.
John Moses,
Director, Collection Strategies Division.
[FR Doc. 2010-22187 Filed 9-3-10; 8:45 am]
BILLING CODE 6560-50-P