Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Guidance for Industry: Controlled Correspondence Related to Generic Drug Development, 41077-41078 [2018-17787]
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Federal Register / Vol. 83, No. 160 / Friday, August 17, 2018 / Notices
line: Live Microbiome-Based Products
Workshop).
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
SUPPLEMENTARY INFORMATION:
Food and Drug Administration
I. Background
[Docket No. FDA–2018–D–1592]
Live microbiome-based products used
to prevent, treat, or cure a disease or
condition in humans are biological
products. There is increasing interest in
the use of such products for the
treatment and/or prevention of
conditions such as necrotizing
enterocolitis and diarrhea. Historically,
these products have presented with
unique scientific and regulatory
challenges.
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Guidance for
Industry: Controlled Correspondence
Related to Generic Drug Development
II. Topics for Discussion at the Public
Workshop
The topics for discussion at the public
workshop include the clinical,
manufacturing, and regulatory
considerations for live microbiomebased products to prevent, treat, or cure
a disease or condition in humans, and
the objective is to provide a forum for
the exchange of information and
perspectives on these topics.
amozie on DSK3GDR082PROD with NOTICES1
III. Participating in the Public
Workshop
Registration: To register for the public
workshop, please visit the following
website: https://www.eventbrite.com/e/
science-and-regulation-of-livemicrobiome-based-products-used-toprevent-treat-or-cure-diseases-in-tickets44649072578. Please provide complete
contact information for each attendee,
including name, title, affiliation,
address, email, and telephone.
Registration is free and based on
space availability, with priority given to
early registrants. Persons interested in
attending this public workshop must
register by August 28, 2018, midnight
Eastern Time. Early registration is
recommended because seating is
limited; therefore, FDA may limit the
number of participants from each
organization. There will be no onsite
registration.
If you need special accommodations
due to a disability, please contact Loni
Warren Henderson or Sherri Revell no
later than September 10, 2018 (See FOR
FURTHER INFORMATION CONTACT).
Dated: August 13, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–17732 Filed 8–16–18; 8:45 am]
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AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA, Agency, or we) 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 September
17, 2018.
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 0910–0797. 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.m.–12 midnight,
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:
Guidance for Industry: Controlled
Correspondence Related to Generic
Drug Development
OMB Control Number 0910–0797—
Extension
This information collection supports
the above captioned Agency guidance.
FDA has agreed to specific program
enhancements and performance goals
specified in the Generic Drug User Fee
Reauthorization (GDUFA II)
Commitment Letter. One of the
performance goals applies to controlled
correspondence related to generic drug
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41077
development. The GDUFA II
Commitment Letter includes details on
FDA’s commitment to respond to
questions submitted as controlled
correspondence within certain
timeframes. To support these program
goals, we have developed the guidance
entitled ‘‘Controlled Correspondence
Related to Generic Drug Development.’’
The guidance document is intended to
facilitate FDA’s prompt consideration of
controlled correspondence and to assist
in meeting the prescribed timeframes by
providing procedural recommendations
to include the following information in
the inquiry: (1) Name, title, address,
phone number, and entity of the person
submitting the inquiry; (2) a letter of
authorization, if applicable; (3) the FDAassigned control number and
submission date of any previous, related
controlled correspondence that was
accepted for substantial review and
response, if any, as well as a copy of
that previous controlled correspondence
and FDA’s response, if any; (4) the
relevant reference listed drug(s), as
applicable, including the application
number, proprietary (brand) name,
manufacturer, active ingredient, dosage
form, and strength(s); (5) a statement
that the controlled correspondence is
related to a potential abbreviated new
drug application (ANDA) submission to
the Office of Generic Drugs and the
ANDA number, if applicable; (6) a
concise statement of the inquiry; (7) a
recommendation of the appropriate FDA
review discipline; and (8) relevant prior
research and supporting materials.
The GDUFA II Commitment Letter
also includes details on FDA’s
commitment to respond to requests to
clarify ambiguities in FDA’s controlled
correspondence response within certain
timeframes. To facilitate FDA’s prompt
consideration of the request and to
assist in meeting the prescribed
timeframes, the guidance document
recommends including the following
information in the inquiry: (1) Name,
title, address, phone number, and entity
of the person submitting the inquiry; (2)
a letter of authorization, if applicable;
(3) the FDA-assigned control number,
submission date of the controlled
correspondence on which the requestor
is seeking clarification, a copy of that
previous controlled correspondence,
and FDA’s response to the controlled
correspondence; and (4) the clarifying
questions and the corresponding
section(s) of FDA’s controlled
correspondence response on which the
requestor is seeking clarification.
In the Federal Register of May 22,
2018, (83 FR 23692), we published a 60day notice requesting public comment
on the proposed collection of
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41078
Federal Register / Vol. 83, No. 160 / Friday, August 17, 2018 / Notices
information. No comments were
received.
We estimate the burden of the
information collection as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Submission of controlled correspondence
Number of
respondents
Number of
responses per
respondent
Total
annual
responses
Average
burden per
response
Total
hours
Generic drug manufacturers, related industry, and representatives ......................................................................
390
3.8
1,496
5
7,480
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
This is the first extension of the
information collection. We base our
estimate on a review of Agency data of
Fiscal Year submissions for 2014, 2015,
and 2016, which reflects an increase in
submissions that we attribute to an
increase in generic drug development.
Accordingly, we estimate 390 generic
drug manufacturers and related industry
(e.g., contract research organizations
conducting bioanalytical or
bioequivalence clinical trials) or their
representatives will each submit an
average of 3.8 inquiries annually for a
total of 1,496 inquiries [1,496 ÷ 390 =
3.8]. Information submitted with each
inquiry varies widely in content,
depending on the complexity of the
request. Inquiries that are defined as
controlled correspondence may range
from a simple inquiry on generic drug
labeling to a more complex inquiry for
a formulation assessment for a specific
proposed generic drug product. As a
result, these inquiries can vary between
1 and 10 burden hours.
Because the content of inquiries
considered controlled correspondence is
widely varied, we are providing an
average burden hour for each inquiry.
We estimate that it will take an average
of 5 hours per inquiry for industry to
gather necessary information, prepare
the request, and submit the request to
FDA. As a result, we estimate that it will
take an average of 7,480 hours annually
for industry to prepare and submit
inquiries considered controlled
correspondence.
Dated: August 10, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–17787 Filed 8–16–18; 8:45 am]
amozie on DSK3GDR082PROD with NOTICES1
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2018–D–2310]
Process To Request a Review of Food
and Drug Administration’s Decision
Not To Issue Certain Export
Certificates for Devices; Draft
Guidance for Industry and Food and
Drug Administration Staff; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of the draft
guidance entitled ‘‘Process to Request a
Review of FDA’s Decision Not to Issue
Certain Export Certificates for Devices;
Draft Guidance for Industry and Food
and Drug Administration Staff.’’ FDA is
issuing this draft guidance to comply
with changes to the Federal Food, Drug,
and Cosmetic Act (FD&C Act) as
amended by the FDA Reauthorization
Act of 2017 (FDARA), to specify the
process afforded to persons denied a
Certificate to Foreign Government (CFG)
for a device. This draft guidance
describes the information that the
Center for Devices and Radiological
Health (CDRH) and the Center for
Biologics Evaluation and Research
(CBER) will provide to a person whose
request for a CFG for a device is denied,
and the process for seeking review of
such a denial. This draft guidance is not
final nor is it in effect at this time.
DATES: Submit either electronic or
written comments on the draft guidance
by October 16, 2018 to ensure that the
Agency considers your comment on this
draft guidance before it begins work on
the final version of the guidance.
ADDRESSES: You may submit comments
on any guidance at any time as follows:
SUMMARY:
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
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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–D–2310 for ‘‘Process to Request a
Review of FDA’s Decision Not to Issue
Certain Export Certificates for Devices;
Draft Guidance for Industry and Food
and Drug Administration Staff.’’
Received comments 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
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]]>Agencies
[Federal Register Volume 83, Number 160 (Friday, August 17, 2018)]
[Notices]
[Pages 41077-41078]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-17787]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2018-D-1592]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Guidance for
Industry: Controlled Correspondence Related to Generic Drug Development
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA, Agency, or we) 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
September 17, 2018.
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 0910-0797.
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.m.-12
midnight, 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.
Guidance for Industry: Controlled Correspondence Related to Generic
Drug Development
OMB Control Number 0910-0797--Extension
This information collection supports the above captioned Agency
guidance. FDA has agreed to specific program enhancements and
performance goals specified in the Generic Drug User Fee
Reauthorization (GDUFA II) Commitment Letter. One of the performance
goals applies to controlled correspondence related to generic drug
development. The GDUFA II Commitment Letter includes details on FDA's
commitment to respond to questions submitted as controlled
correspondence within certain timeframes. To support these program
goals, we have developed the guidance entitled ``Controlled
Correspondence Related to Generic Drug Development.'' The guidance
document is intended to facilitate FDA's prompt consideration of
controlled correspondence and to assist in meeting the prescribed
timeframes by providing procedural recommendations to include the
following information in the inquiry: (1) Name, title, address, phone
number, and entity of the person submitting the inquiry; (2) a letter
of authorization, if applicable; (3) the FDA-assigned control number
and submission date of any previous, related controlled correspondence
that was accepted for substantial review and response, if any, as well
as a copy of that previous controlled correspondence and FDA's
response, if any; (4) the relevant reference listed drug(s), as
applicable, including the application number, proprietary (brand) name,
manufacturer, active ingredient, dosage form, and strength(s); (5) a
statement that the controlled correspondence is related to a potential
abbreviated new drug application (ANDA) submission to the Office of
Generic Drugs and the ANDA number, if applicable; (6) a concise
statement of the inquiry; (7) a recommendation of the appropriate FDA
review discipline; and (8) relevant prior research and supporting
materials.
The GDUFA II Commitment Letter also includes details on FDA's
commitment to respond to requests to clarify ambiguities in FDA's
controlled correspondence response within certain timeframes. To
facilitate FDA's prompt consideration of the request and to assist in
meeting the prescribed timeframes, the guidance document recommends
including the following information in the inquiry: (1) Name, title,
address, phone number, and entity of the person submitting the inquiry;
(2) a letter of authorization, if applicable; (3) the FDA-assigned
control number, submission date of the controlled correspondence on
which the requestor is seeking clarification, a copy of that previous
controlled correspondence, and FDA's response to the controlled
correspondence; and (4) the clarifying questions and the corresponding
section(s) of FDA's controlled correspondence response on which the
requestor is seeking clarification.
In the Federal Register of May 22, 2018, (83 FR 23692), we
published a 60-day notice requesting public comment on the proposed
collection of
[[Page 41078]]
information. No comments were received.
We estimate the burden of the information collection as follows:
Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
Submission of controlled correspondence Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
--------------------------------------------------------------------------------------------------------------------------------------------------------
Generic drug manufacturers, related industry, and representatives.. 390 3.8 1,496 5 7,480
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
This is the first extension of the information collection. We base
our estimate on a review of Agency data of Fiscal Year submissions for
2014, 2015, and 2016, which reflects an increase in submissions that we
attribute to an increase in generic drug development. Accordingly, we
estimate 390 generic drug manufacturers and related industry (e.g.,
contract research organizations conducting bioanalytical or
bioequivalence clinical trials) or their representatives will each
submit an average of 3.8 inquiries annually for a total of 1,496
inquiries [1,496 / 390 = 3.8]. Information submitted with each inquiry
varies widely in content, depending on the complexity of the request.
Inquiries that are defined as controlled correspondence may range from
a simple inquiry on generic drug labeling to a more complex inquiry for
a formulation assessment for a specific proposed generic drug product.
As a result, these inquiries can vary between 1 and 10 burden hours.
Because the content of inquiries considered controlled
correspondence is widely varied, we are providing an average burden
hour for each inquiry. We estimate that it will take an average of 5
hours per inquiry for industry to gather necessary information, prepare
the request, and submit the request to FDA. As a result, we estimate
that it will take an average of 7,480 hours annually for industry to
prepare and submit inquiries considered controlled correspondence.
Dated: August 10, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-17787 Filed 8-16-18; 8:45 am]
BILLING CODE 4164-01-P
