Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Formal Meetings Between the Food and Drug Administration and Sponsors and Applicants of Prescription Drug User Fee Act Products, 71430-71431 [2019-27835]
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Federal Register / Vol. 84, No. 248 / Friday, December 27, 2019 / Notices
ANA plans to modify the description of
program purpose for the SEDS–AK FOA
to expand the program areas of interest
beyond governance. In addition, ANA
wants to provide a competitive
advantage for smaller Alaska Native
villages or organizations that have never
received ANA funding. Therefore, the
FOA will state that reviewers may add
up to 10 bonus points in the scoring
criteria if an eligible entity that has
never received an ANA award. ANA
staff will confirm during the objective
review process whether or not an
applicant organization for SEDS–AK has
received a past ANA award.
a. Changes to EMI FOA—Section 803C
of NAPA, 42 U.S.C. 2991b–3. In
accordance with 42 U.S.C. 2991b–
3(c)(7), applicants for an EMI grant must
provide a certification that the
organization has not less than 3 years of
experience in operating and
administering a Native American
language survival school, a Native
American language nest, or any other
educational program in which
instruction is conducted in a Native
American language. Previously, this
requirement only applied to Native
American language survival schools.
ANA will now require all applicants for
EMI to provide a certification of
operation of not less than 3 years.
b. Clarification to ERE FOA—Section
803 of NAPA, 42 U.S.C. 2991b.
i. Section 803(d)(3) of NAPA (42
U.S.C. 2991b(d)(3)) permits Federal
funds to be used as cost sharing or
matching funds for an ERE project, as
long as they are not provided from other
ANA grants. Therefore, ANA will add
this clarification in the ERE FOA. Before
using Federal grant funds as matching
funds, grantees must make sure that the
authorizing statute for the matching
Federal grant funds specifically allows
its grant funds to be used as cost share
or matching funds.
ii. ANA will also permit entities to
apply for ERE grants even if they do not
own land. There is no requirement
within the provisions for ERE under
NAPA that require the eligible entity to
own land. Applications will be
evaluated in accordance with the
evaluation criteria in the FOA,
including ensuring the purpose of the
ERE program will be met.
jbell on DSKJLSW7X2PROD with NOTICES
Statutory Authority: Section 814 of the
Native American Programs Act of 1974
(NAPA), as amended.
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Jkt 250001
Food and Drug Administration
[Docket No. FDA–2018–N–2434]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Formal Meetings
Between the Food and Drug
Administration and Sponsors and
Applicants of Prescription Drug User
Fee Act Products
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
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 January 27,
2020.
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 0910–0429. Also
include the FDA docket number found
in brackets in the heading of this
document.
SUMMARY:
FOR FURTHER INFORMATION CONTACT:
Domini Bean, Office of Operations,
Food and Drug Administration, Three
White Flint North, 10A–12M, 11601
Landsdown St., North Bethesda, MD
20852, 301–796–5733, PRAStaff@
fda.hhs.gov.
In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
SUPPLEMENTARY INFORMATION:
Formal Meetings Between FDA and
Sponsors and Applicants of
Prescription Drug User Fee Act
Products
OMB Control Number 0910–0429—
Reinstatement
Jean Hovland,
Commissioner, Administration for Native
Americans, Administration for Children and
Families.
[FR Doc. 2019–27916 Filed 12–26–19; 8:45 am]
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
This information collection supports
implementation of the Prescription Drug
User Fee Amendments (PDUFA) of the
FDA Reauthorization Act of 2017
(FDARA). Consistent with Agency
regulations and provisions found in our
PO 00000
Frm 00083
Fmt 4703
Sfmt 4703
‘‘Reauthorization Performance Goals
And Procedures: Fiscal Years 2018
Through 2022,’’ we have established
procedural guidance pertaining to
formal meetings between FDA and
sponsors or applicants of certain drug or
biological drug products regulated by
the Center for Drug Evaluation (CDER)
and Research and the Center for
Biologics Evaluation and Research
(CBER). Because these meetings often
represent critical points in the
regulatory process, we intend these
recommendations to facilitate the timely
and effective scheduling of such
meetings, as well as ensure their
efficiency and appropriate
documentation.
While FDA regulations in 21 CFR
10.65, 312.47, 314.50, and 314.102
describe general considerations and set
forth certain information collection
elements pertaining to meetings with
FDA, the guidance document entitled,
‘‘Formal Meetings Between the FDA and
Sponsors or Applicants of PDUFA
Products,’’ discusses specific topics for
sponsors of PDUFA products such as
types of meetings, meeting formats,
meetings requests, FDA response, and
meeting packages. The guidance
recommendations do not apply to
abbreviated new drug applications,
applications for biosimilar biological
products, or submissions for medical
devices. Issued consistent with our
Good Guidance Practice regulations in
21 CFR 10.115, we originally developed
the guidance in 1999 and it has since
undergone various revisions to reflect
reauthorization of relevant user fee
legislation. The guidance explains our
recommendations with regard to
PDUFA meetings and that the following
elements be included in a meeting
request to FDA:
• Information identifying and
describing the product;
• the type of meeting being requested;
a brief statement of the purpose of the
meeting;
• a list of objectives and expected
outcomes from the meeting;
• a preliminary proposed agenda; a
draft list of questions to be raised at the
meeting;
• a list of individuals who will
represent the sponsor or applicant at the
meeting;
• a list of Agency staff requested to be
in attendance;
• the approximate date that the
information package will be sent to the
Agency;
• and suggested dates and times for
the meeting.
We use the information to determine
the purpose of the meeting and to
E:\FR\FM\27DEN1.SGM
27DEN1
71431
Federal Register / Vol. 84, No. 248 / Friday, December 27, 2019 / Notices
arrange for scheduling and participation
as appropriate.
Similarly, the guidance explains and
discusses the preparation of an
‘‘information package’’ and recommends
that it include the following
information:
• Identifying information about the
underlying product;
• a brief statement of the purpose of
the meeting; a list of objectives and
expected outcomes of the meeting;
• a proposed agenda for the meeting;
• a list of specific questions to be
addressed at the meeting;
• a summary of clinical data that will
be discussed (as appropriate);
• a summary of preclinical data that
will be discussed (as appropriate); and
• chemistry, manufacturing, and
controls information that may be
discussed (as appropriate).
The information package enables us to
prepare for the meeting and allows
appropriate time for reviewing relevant
product data. Although FDA reviews
similar information in the meeting
request, the information package should
provide updated data reflecting the most
current and accurate information
available to the sponsor or applicant.
In the Federal Register of July 11,
2018 (83 FR 32130) we published a 60day notice under the Paperwork
Reduction Act of 1995 (PRA) requesting
public comment on the proposed
collection of information associated
with meeting requests under PDUFA.
No comments were received in response
to the PRA notice. Separately, in the
Federal Register (December 29, 2017; 82
FR 61763), we published a notice of
availability announcing a 2017 revised
draft version of the subject guidance,
ultimately intending it to replace the
current 2009 version. In the December
2017 notice of availability, the 2009
version was inadvertently withdrawn
and the associated information
collection discontinued. Accordingly,
we are requesting reinstatement of the
information collection. Although the
associated guidance is currently being
revised to reflect 2018–2022 PDUFA
reauthorization goals and is being
issued consistent with our Good
Guidance Practice Regulation at 21 CFR
10.115, no changes have been made to
the information collection elements
recommended, nor have we modified
the burden estimate we ascribe to the
related activities.
We therefore estimate the burden of
the information collection as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
Guidance recommendations
Total annual
responses
Average
burden per
response
Total hours
Meeting Requests:
CDER ............................................................................
CBER ............................................................................
1,319
301
2.31
1.21
3,058
363
10
10
30,580
3,630
Subtotal ..................................................................
........................
........................
........................
........................
34,210
Information Packages:
CDER ............................................................................
CBER ............................................................................
1,149
187
2.19
1.12
2,522
210
18
18
45,396
3,780
Subtotal ..................................................................
........................
........................
........................
........................
49,176
Total ................................................................
........................
........................
........................
........................
83,386
1 There
jbell on DSKJLSW7X2PROD with NOTICES
Number of
responses per
respondent
are no capital costs or operating and maintenance costs associated with this collection of information.
Our estimate reflects an overall
increase since the previous OMB
approval. We attribute this adjustment
to an increase in the number of PDUFArelated meeting requests and
information packages we have received
over the last few years.
Based on Agency data, we estimate
1,319 sponsors and applicants
(respondents) request 3,058 formal
meetings with CDER annually, and 301
respondents request 363 formal
meetings with CBER annually regarding
the development and review of a
PDUFA product. The hours per
response, which is the estimated
number of hours that a respondent
spends preparing the information to be
submitted with a meeting request in
accordance with the guidance, is
estimated to be 10 hours. We expect it
takes this amount of time to gather and
copy brief statements about the product
as well as a description of the purpose
and details of the meeting.
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Also consistent with Agency data, we
estimate 1,149 respondents submitted
2,522 information packages to CDER
annually, and 187 respondents
submitted 210 information packages to
CBER annually, prior to a formal
meeting regarding the development and
review of a PDUFA product. We
estimate 18 hours is needed to prepare
the information package in accordance
with the guidance.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Dated: December 10, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
ACTION:
[FR Doc. 2019–27835 Filed 12–26–19; 8:45 am]
BILLING CODE 4164–01–P
PO 00000
Frm 00084
Fmt 4703
Sfmt 4703
Health Resources and Services
Administration
National Vaccine Injury Compensation
Program: List of Petitions Received
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services (HHS).
AGENCY:
Notice.
HRSA is publishing this
notice of petitions received under the
National Vaccine Injury Compensation
Program (the Program), as required by
Section 2112(b)(2) of the Public Health
Service (PHS) Act, as amended. While
the Secretary of HHS is named as the
respondent in all proceedings brought
by the filing of petitions for
compensation under the Program, the
United States Court of Federal Claims is
charged by statute with responsibility
SUMMARY:
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]]>Agencies
[Federal Register Volume 84, Number 248 (Friday, December 27, 2019)]
[Notices]
[Pages 71430-71431]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-27835]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2018-N-2434]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Formal Meetings
Between the Food and Drug Administration and Sponsors and Applicants of
Prescription Drug User Fee Act Products
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 January
27, 2020.
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 [email protected]. All
comments should be identified with the OMB control number 0910-0429.
Also include the FDA docket number found in brackets in the heading of
this document.
FOR FURTHER INFORMATION CONTACT: Domini Bean, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852, 301-796-5733,
[email protected].
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.
Formal Meetings Between FDA and Sponsors and Applicants of Prescription
Drug User Fee Act Products
OMB Control Number 0910-0429--Reinstatement
This information collection supports implementation of the
Prescription Drug User Fee Amendments (PDUFA) of the FDA
Reauthorization Act of 2017 (FDARA). Consistent with Agency regulations
and provisions found in our ``Reauthorization Performance Goals And
Procedures: Fiscal Years 2018 Through 2022,'' we have established
procedural guidance pertaining to formal meetings between FDA and
sponsors or applicants of certain drug or biological drug products
regulated by the Center for Drug Evaluation (CDER) and Research and the
Center for Biologics Evaluation and Research (CBER). Because these
meetings often represent critical points in the regulatory process, we
intend these recommendations to facilitate the timely and effective
scheduling of such meetings, as well as ensure their efficiency and
appropriate documentation.
While FDA regulations in 21 CFR 10.65, 312.47, 314.50, and 314.102
describe general considerations and set forth certain information
collection elements pertaining to meetings with FDA, the guidance
document entitled, ``Formal Meetings Between the FDA and Sponsors or
Applicants of PDUFA Products,'' discusses specific topics for sponsors
of PDUFA products such as types of meetings, meeting formats, meetings
requests, FDA response, and meeting packages. The guidance
recommendations do not apply to abbreviated new drug applications,
applications for biosimilar biological products, or submissions for
medical devices. Issued consistent with our Good Guidance Practice
regulations in 21 CFR 10.115, we originally developed the guidance in
1999 and it has since undergone various revisions to reflect
reauthorization of relevant user fee legislation. The guidance explains
our recommendations with regard to PDUFA meetings and that the
following elements be included in a meeting request to FDA:
Information identifying and describing the product;
the type of meeting being requested; a brief statement of
the purpose of the meeting;
a list of objectives and expected outcomes from the
meeting;
a preliminary proposed agenda; a draft list of questions
to be raised at the meeting;
a list of individuals who will represent the sponsor or
applicant at the meeting;
a list of Agency staff requested to be in attendance;
the approximate date that the information package will be
sent to the Agency;
and suggested dates and times for the meeting.
We use the information to determine the purpose of the meeting and
to
[[Page 71431]]
arrange for scheduling and participation as appropriate.
Similarly, the guidance explains and discusses the preparation of
an ``information package'' and recommends that it include the following
information:
Identifying information about the underlying product;
a brief statement of the purpose of the meeting; a list of
objectives and expected outcomes of the meeting;
a proposed agenda for the meeting;
a list of specific questions to be addressed at the
meeting;
a summary of clinical data that will be discussed (as
appropriate);
a summary of preclinical data that will be discussed (as
appropriate); and
chemistry, manufacturing, and controls information that
may be discussed (as appropriate).
The information package enables us to prepare for the meeting and
allows appropriate time for reviewing relevant product data. Although
FDA reviews similar information in the meeting request, the information
package should provide updated data reflecting the most current and
accurate information available to the sponsor or applicant.
In the Federal Register of July 11, 2018 (83 FR 32130) we published
a 60-day notice under the Paperwork Reduction Act of 1995 (PRA)
requesting public comment on the proposed collection of information
associated with meeting requests under PDUFA. No comments were received
in response to the PRA notice. Separately, in the Federal Register
(December 29, 2017; 82 FR 61763), we published a notice of availability
announcing a 2017 revised draft version of the subject guidance,
ultimately intending it to replace the current 2009 version. In the
December 2017 notice of availability, the 2009 version was
inadvertently withdrawn and the associated information collection
discontinued. Accordingly, we are requesting reinstatement of the
information collection. Although the associated guidance is currently
being revised to reflect 2018-2022 PDUFA reauthorization goals and is
being issued consistent with our Good Guidance Practice Regulation at
21 CFR 10.115, no changes have been made to the information collection
elements recommended, nor have we modified the burden estimate we
ascribe to the related activities.
We therefore estimate the burden of the information collection as
follows:
Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of
Guidance recommendations Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
----------------------------------------------------------------------------------------------------------------
Meeting Requests:
CDER........................ 1,319 2.31 3,058 10 30,580
CBER........................ 301 1.21 363 10 3,630
-------------------------------------------------------------------------------
Subtotal................ .............. .............. .............. .............. 34,210
-------------------------------------------------------------------------------
Information Packages:
CDER........................ 1,149 2.19 2,522 18 45,396
CBER........................ 187 1.12 210 18 3,780
-------------------------------------------------------------------------------
Subtotal................ .............. .............. .............. .............. 49,176
-------------------------------------------------------------------------------
Total............... .............. .............. .............. .............. 83,386
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Our estimate reflects an overall increase since the previous OMB
approval. We attribute this adjustment to an increase in the number of
PDUFA-related meeting requests and information packages we have
received over the last few years.
Based on Agency data, we estimate 1,319 sponsors and applicants
(respondents) request 3,058 formal meetings with CDER annually, and 301
respondents request 363 formal meetings with CBER annually regarding
the development and review of a PDUFA product. The hours per response,
which is the estimated number of hours that a respondent spends
preparing the information to be submitted with a meeting request in
accordance with the guidance, is estimated to be 10 hours. We expect it
takes this amount of time to gather and copy brief statements about the
product as well as a description of the purpose and details of the
meeting.
Also consistent with Agency data, we estimate 1,149 respondents
submitted 2,522 information packages to CDER annually, and 187
respondents submitted 210 information packages to CBER annually, prior
to a formal meeting regarding the development and review of a PDUFA
product. We estimate 18 hours is needed to prepare the information
package in accordance with the guidance.
Dated: December 10, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-27835 Filed 12-26-19; 8:45 am]
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