Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Generic Drug User Fee Cover Sheet, 2532-2533 [2019-01477]
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Federal Register / Vol. 84, No. 26 / Thursday, February 7, 2019 / Notices
meetings. Please visit our website at
https://www.fda.gov/Advisory
Committees/AboutAdvisoryCommittees/
ucm111462.htm for procedures on
public conduct during advisory
committee meetings.
Notice of this meeting is given under
the Federal Advisory Committee Act (5
U.S.C. app. 2).
Dated: February 1, 2019.
Lowell J. Schiller,
Acting Associate Commissioner for Policy.
[FR Doc. 2019–01481 Filed 2–6–19; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
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: In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
OMB Control Number 0910–0727—
Extension
[Docket No. FDA–2018–N–3404]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Generic Drug User
Fee Cover Sheet
Food and Drug Administration,
HHS.
ACTION:
FOR FURTHER INFORMATION CONTACT:
Generic Drug User Fee Coversheet
Food and Drug Administration
AGENCY:
OMB control number 0910–0727. Also
include the FDA docket number found
in brackets in the heading of this
document.
Notice.
The Food and Drug
Administration (FDA) is announcing
that a proposed collection of
information has been submitted to the
Office of Management and Budget
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
DATES: Fax written comments on the
collection of information by March 11,
2019.
ADDRESSES: To ensure that comments on
the information collection are received,
OMB recommends that written
comments be faxed to the Office of
Information and Regulatory Affairs,
OMB, Attn: FDA Desk Officer, Fax: 202–
395–7285, or emailed to oira_
submission@omb.eop.gov. All
comments should be identified with the
SUMMARY:
On July 9, 2012, the President signed
the Generic Drug User Fee Amendments
(GDUFA) (Pub. L. 112–144, Title III)
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-coversheet.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 the collection of
information are 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.
In the Federal Register of September
25, 2018 (83 FR 48430), we published a
60-day notice requesting public
comment on the proposed collection of
information. One comment was received
asking whether the information was
‘‘essential for FDA to conduct its
duties,’’ and whether ‘‘there is a way to
reduce burden’’ on respondents. We
appreciate this feedback. As discussed
in both the 60-day notice and this
notice, the information collection
implements statutory provisions FDA
must fulfill under GDUFA II. The
information requested from respondents
on Form FDA 3794 represents what we
consider to be the minimum necessary
for us to efficiently and electronically
assess, collect, and track user fees
associated with generic drug
applications.
We estimate the burden of the
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Form FDA 3794
Number of
respondents
Number of
responses per
respondent
Total annual
responses
Average burden
per response
Total hours
Generic Drug User Fee Cover Sheet ..........................
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.
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2533
Federal Register / Vol. 84, No. 26 / Thursday, February 7, 2019 / Notices
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: February 4, 2019.
Lowell J. Schiller,
Acting Associate Commissioner for Policy.
[FR Doc. 2019–01477 Filed 2–6–19; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Agency Information Collection
Activities: Submission to OMB for
Review and Approval; Public Comment
Request; Children’s Graduate Medical
Education Quality Bonus System
(QBS) Initiative Response Form, OMB
No. 0906–xxxx–New
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services (HHS).
ACTION: Notice.
AGENCY:
In compliance with the
Paperwork Reduction Act of 1995,
HRSA has submitted an Information
Collection Request (ICR) to the Office of
Management and Budget (OMB) for
review and approval. Comments
submitted during the first public review
of this ICR will be provided to OMB.
OMB will accept further comments from
the public during the review and
approval period.
DATES: Comments on this ICR should be
received no later than March 11, 2019.
ADDRESSES: Submit your comments,
including the ICR Title, to the desk
officer for HRSA either by email to
SUMMARY:
OIRA_submission@omb.eop.gov or by
fax to (202) 395–5806.
FOR FURTHER INFORMATION CONTACT: To
request a copy of the clearance requests
submitted to OMB for review, email Lisa
Wright-Solomon, the HRSA Information
Collection Clearance Officer at
paperwork@hrsa.gov or call (301) 443–
1984.
SUPPLEMENTARY INFORMATION: When
submitting comments or requesting
information, please include the
information request collection title for
reference.
Information Collection Request Title:
Quality Bonus System Initiative
Response Form OMB No. 0906–xxxx
[New].
Abstract: The Children’s Hospitals
Graduate Medical Education (CHGME)
Payment Program provides federal
funds to the nation’s freestanding
children’s hospitals to help them
maintain their graduate medical
education programs that train resident
physicians and dentists. CHGME
Support Reauthorization Act of 2013
states that the Secretary may establish a
Quality Bonus System (QBS), whereby
the Secretary distributes bonus
payments to hospitals participating in
the CHGME Payment Program that meet
standards specified by the Secretary. In
order to qualify for the QBS payment in
Fiscal Year (FY) 2019, CHGME award
recipients must submit documentation
as an attachment in the FY 2019
reconciliation application released in
April 2019, describing the hospital’s
initiatives, resident curriculum, and
direct resident involvement in the
following areas:
a. Integrated care models (e.g.,
integrated behavioral and mental health,
care coordination across providers and
settings);
b. Telehealth and/or Health
Information Technology;
c. Population health;
d. Social determinants of health; and
e. Additional initiatives to improve
access and quality of care to rural and/
or underserved communities.
A 60-day notice was published in the
Federal Register on October 23, 2018,
Vol. 83, No. 205.
Need and Proposed Use of the
Information: As specified in the CHGME
statute, the QBS payment shall be
remitted to qualified hospitals
participating in the CHGME program
that meet standards set forth by the
Secretary of HHS. To demonstrate the
fulfillment of such standards, it will be
necessary for applicants to complete the
QBS Response Initiative form and
submit it as an attachment to the FY
2019 reconciliation application released
in April of 2019. This form will be used
to gather information relating to the
hospitals’ engagement in quality
initiatives.
Likely Respondents: CHGME Program
award recipients.
Burden Statement: Burden in this
context means the time expended by
persons to generate, maintain, retain,
disclose or provide the information
requested. This includes the time
needed to review instructions; to
develop, acquire, install and utilize
technology and systems for the purpose
of collecting, validating and verifying
information, processing and
maintaining information, and disclosing
and providing information; to train
personnel and to be able to respond to
a collection of information; to search
data sources; to complete and review
the collection of information; and to
transmit or otherwise disclose the
information. The total annual burden
hours estimated for this ICR are
summarized in the table below.
TOTAL ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents
Form name
Number of
responses per
respondent
Total
responses
Average
burden per
response
(in hours)
Total
burden
hours
QBS Response Initiative Form ............................................
58
1
58
32.41
1,880
Total ..............................................................................
58
........................
58
........................
1,880
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]]>Agencies
[Federal Register Volume 84, Number 26 (Thursday, February 7, 2019)]
[Notices]
[Pages 2532-2533]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-01477]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2018-N-3404]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Generic Drug User Fee
Cover Sheet
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing that a
proposed collection of information has been submitted to the Office of
Management and Budget (OMB) for review and clearance under the
Paperwork Reduction Act of 1995.
DATES: Fax written comments on the collection of information by March
11, 2019.
ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be faxed to the Office
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer,
Fax: 202-395-7285, or emailed to oira_submission@omb.eop.gov. All
comments should be identified with the OMB control number 0910-0727.
Also include the FDA docket number found in brackets in the heading of
this document.
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: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.
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 III) 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 the collection of information are 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.
In the Federal Register of September 25, 2018 (83 FR 48430), we
published a 60-day notice requesting public comment on the proposed
collection of information. One comment was received asking whether the
information was ``essential for FDA to conduct its duties,'' and
whether ``there is a way to reduce burden'' on respondents. We
appreciate this feedback. As discussed in both the 60-day notice and
this notice, the information collection implements statutory provisions
FDA must fulfill under GDUFA II. The information requested from
respondents on Form FDA 3794 represents what we consider to be the
minimum necessary for us to efficiently and electronically assess,
collect, and track user fees associated with generic drug applications.
We estimate the burden of the collection of information as follows:
Table 1--Estimated Annual Reporting Burden 1
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
Form FDA 3794 Number of responses per Total annual Average burden per response Total hours
respondents respondent responses
--------------------------------------------------------------------------------------------------------------------------------------------------------
Generic Drug User Fee Cover Sheet.......... 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.
[[Page 2533]]
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: February 4, 2019.
Lowell J. Schiller,
Acting Associate Commissioner for Policy.
[FR Doc. 2019-01477 Filed 2-6-19; 8:45 am]
BILLING CODE 4164-01-P
