Agency Information Collection Activities; Proposed Collection; Comment Request; Safety Labeling Changes-Implementation of Section 505(o)(4) of the Federal Food, Drug, and Cosmetic Act, 3460-3462 [2019-01918]
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3460
Federal Register / Vol. 84, No. 29 / Tuesday, February 12, 2019 / Notices
20852, 301–796–7726, 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.
Assessment of Combination Product
Review Practices
OMB Control Number 0910–NEW
In 1991, FDA’s Center for Biologics
Evaluation and Research (CBER), Center
for Drug Evaluation and Research
(CDER), and Center for Devices and
Radiological Health entered into
‘‘Intercenter Agreements’’ to provide
guidance on the classification and
assignment of medical products and to
clarify jurisdiction over combination
product reviews. With the enactment of
the Medical Device User Fee and
Modernization Act of 2002, FDA aimed
to achieve prompt assignment of
combination products, timely and
effective premarket reviews, and
consistent and appropriate postmarket
regulation through the establishment of
the Office of Combination Products
(OCP). Since then, OCP has operated to
further standardize combination
product guidance to FDA and industry
and facilitate coordination between
FDA’s medical product review Centers.
As part of the 2017 reauthorization of
the Prescription Drug User Fee Act
(PDUFA), FDA committed to advance
the development of drug-device and
biologic-device combination products
regulated by CDER and CBER through
modernization of the combination
product review program. To that end,
FDA committed to contracting with an
independent third party to assess
current practices for combination drug
product review, to include interviews
with combination product sponsors and
applicants. The contractor for the
assessment of combination drug product
review practices is Eastern Research
Group, Inc. (ERG).
Therefore, in accordance with the
PDUFA VI Commitment Letter, FDA
proposes to have ERG conduct
independent interviews of combination
product sponsors and applicants during
the data collection period as follows:
• Sponsors with a Request For
Designation (RFD) or pre-RFD submitted
during the data collection period.
• Sponsors with a combination
product Investigational New Drug (IND)
or pre-IND submitted during the data
collection period.
• Applicants with a combination
product New Drug Application (NDA)
or Biologics License Application (BLA)
that receives a first-cycle action from
FDA during the data collection period.
The purpose of these interviews is to
collect voluntary feedback from
combination product sponsors and
applicants on their experience with
FDA during the development and
review of their products, including any
challenges or best practices. ERG will
anonymize and aggregate sponsor/
applicant responses prior to inclusion in
the assessment. ERG will use interview
responses to complement and
supplement data on combination
product review parameters obtained
through other means, such as extraction
of data from FDA corporate databases
and interviews with FDA review staff.
FDA will publish ERG’s assessment
(with interview results and findings) on
the Agency’s public website and a link
to the assessment in the Federal
Register for public comment.
In the Federal Register of September
27, 2018 (83 FR 48822), FDA published
a 60-day notice requesting public
comment on the proposed collection of
information. No comments were
received.
Sponsors submit approximately 150
to 180 RFDs/pre-RFDs and 200 to 240
combination product original INDs/preINDs per year. ERG will interview 1 to
3 sponsor representatives at a time for
up to 35 RFDs/pre-RFDs and 48 INDs
received by FDA—up to 105 RFD/preRFD and 144 IND/pre-IND sponsor
representatives per year. FDA typically
reviews approximately 25 to 30
combination product original NDAs and
original BLAs per year. ERG will
interview 1 to 3 applicant
representatives at a time for each
application that receives a first-cycle
action from FDA—up to 90
representatives per year. Thus, FDA
estimates the burden of this collection
of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
Portion of study
Number of
responses per
respondent
Total annual
responses
Average
burden per
response
Total hours 1
Pretest ..................................................................................
Interviews .............................................................................
5
339
1
1
5
339
1.5
1.5
7.5
508.5
Total ..............................................................................
........................
........................
........................
........................
516
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
ERG will conduct a pretest of the
interview protocol with five
respondents. FDA estimates that it will
take 1 to 1.5 hours to complete the
pretest, for a total of a maximum of 7.5
hours. FDA estimates that up to 339
respondents will take part in the
interviews each year, with each
interview lasting 1 to 1.5 hours, for a
total of a maximum of 508.5 hours.
Thus, the total estimated annual burden
is 516 hours. FDA’s burden estimate is
based on prior experience with similar
interviews with the regulated
community.
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18:30 Feb 11, 2019
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Dated: February 6, 2019.
Lowell J. Schiller,
Acting Associate Commissioner for Policy.
[FR Doc. 2019–01979 Filed 2–11–19; 8:45 am]
Food and Drug Administration
[Docket No. FDA–2018–N–4735]
BILLING CODE 4164–01–P
PO 00000
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Safety Labeling
Changes—Implementation of Section
505(o)(4) of the Federal Food, Drug,
and Cosmetic Act
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
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Notice.
12FEN1
Federal Register / Vol. 84, No. 29 / Tuesday, February 12, 2019 / Notices
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 safety labeling
changes and the implementation of a
certain section of the Federal Food,
Drug, and Cosmetic Act (FD&C Act).
SUMMARY:
Submit either electronic or
written comments on the collection of
information by April 15, 2019.
DATES:
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 April 15,
2019. The https://www.regulations.gov
electronic filing system will accept
comments until 11:59 p.m. Eastern Time
at the end of April 15, 2019. 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.
ADDRESSES:
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
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18:30 Feb 11, 2019
Jkt 247001
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–4735 for ‘‘Agency Information
Collection Activities; Proposed
Collection; Comment Request; Guidance
for Industry: Safety Labeling Changes—
Implementation of Section 505(o)(4) of
the Federal Food, Drug, and Cosmetic
Act.’’ 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
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3461
the information at: https://www.gpo.gov/
fdsys/pkg/FR-2015-09-18/pdf/201523389.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:
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.
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.
SUPPLEMENTARY INFORMATION:
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.
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3462
Federal Register / Vol. 84, No. 29 / Tuesday, February 12, 2019 / Notices
Safety Labeling Changes—
Implementation of Section 505(o)(4) of
the Federal Food, Drug, and Cosmetic
Act
OMB Control Number 0910–0734—
Extension
Section 505(o)(4) of the FD&C Act (21
U.S.C. 355(o)(4)) authorizes FDA to
require and, if necessary, order labeling
changes if FDA becomes aware of new
safety information that it believes
should be included in the labeling of
certain prescription drug and biological
products approved under section 505 of
the FD&C Act or section 351 of the
Public Health Service Act (PHS Act) (42
U.S.C. 262). Section 505(o)(4) of the
FD&C Act applies to prescription drug
products with an approved new drug
application (NDA) under section 505(b)
of the FD&C Act, biological products
with an approved biologics license
application under section 351 of the
PHS Act, or prescription drug products
with an approved abbreviated new drug
application under section 505(j) of the
FD&C Act if the reference listed drug
with an approved NDA is not currently
marketed. Section 505(o)(4) imposes
time frames for application holders to
submit, and FDA staff to review, such
changes and gives FDA enforcement
tools to bring about timely and
appropriate labeling changes. To
implement these provisions we
developed the guidance entitled
‘‘Guidance for Industry: Safety Labeling
Changes—Implementation of Section
505(o)(4) of the Federal Food, Drug, and
Cosmetic Act,’’ which provides
instruction on: (1) A description of the
types of safety labeling changes that
ordinarily might be required; (2) how
FDA plans to determine what
constitutes new safety information; (3)
the procedures involved in requiring
safety labeling changes, and (4)
enforcement of the requirements for
safety labeling changes. The guidance is
available on our website at https://
www.fda.gov/downloads/drugs/
guidancecomplianceregulatory
information/guidances/ucm250783.pdf.
FDA requires safety labeling changes
by sending a notification letter to the
application holder. Under section
505(o)(4)(B) of the FD&C Act, the
application holder must respond to
FDA’s notification by submitting a
labeling supplement or notifying FDA
that the applicant does not believe the
labeling change is warranted and by
submitting a statement detailing why
the application holder does not believe
a change is warranted (a rebuttal
statement).
Based on our experience to date with
safety labeling changes requirements
under section 505(o)(4) of the FD&C Act,
we estimate that approximately 36
application holders will elect to submit
approximately 1 rebuttal statement each
year and that each rebuttal statement
will take approximately 6 hours to
prepare.
In addition, the guidance explains
that labeling prepared in response to a
safety labeling change notification
should be available on the application
holder’s website within 10 calendar
days of approval. We estimate that
approximately 351 application holders
will post new labeling one time each
year in response to a safety labeling
change notification and that the posting
of the labeling will take approximately
4 hours to prepare.
We estimate the burden of the
information collection as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Activity
Number of
respondents
Number of
responses per
respondent
Total annual
responses
Average
burden per
response
Total hours
Rebuttal statement ...............................................................
36
1
36
6
216
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
TABLE 2—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1
Type of submission
Number of
respondents
Number of
disclosures
per
respondent
Total annual
disclosures
Average
burden per
disclosure
Total hours
Posting approved labeling on application holder’s website
351
1
351
4
1,404
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
We have adjusted our estimated
annual number of respondents
downward by 62 since the last OMB
approval of the information collection.
The decrease reflects that we have
issued fewer safety labeling
notifications, and thus fewer postings
are required and fewer rebuttals are
expected.
Dated: February 6, 2019.
Lowell J. Schiller,
Acting Associate Commissioner for Policy.
[FR Doc. 2019–01918 Filed 2–11–19; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2014–N–1721]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Investigational
New Drug Applications
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing
that a proposed collection of
SUMMARY:
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18:30 Feb 11, 2019
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PO 00000
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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 14,
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 0910–0014. Also
include the FDA docket number found
E:\FR\FM\12FEN1.SGM
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]]>Agencies
[Federal Register Volume 84, Number 29 (Tuesday, February 12, 2019)]
[Notices]
[Pages 3460-3462]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-01918]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2018-N-4735]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Safety Labeling Changes--Implementation of Section
505(o)(4) of the Federal Food, Drug, and Cosmetic Act
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
[[Page 3461]]
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 safety labeling changes and the
implementation of a certain section of the Federal Food, Drug, and
Cosmetic Act (FD&C Act).
DATES: Submit either electronic or written comments on the collection
of information by April 15, 2019.
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 April 15, 2019. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of April 15, 2019. 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-4735 for ``Agency Information Collection Activities;
Proposed Collection; Comment Request; Guidance for Industry: Safety
Labeling Changes--Implementation of Section 505(o)(4) of the Federal
Food, Drug, and Cosmetic Act.'' 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: 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.
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.
[[Page 3462]]
Safety Labeling Changes--Implementation of Section 505(o)(4) of the
Federal Food, Drug, and Cosmetic Act
OMB Control Number 0910-0734--Extension
Section 505(o)(4) of the FD&C Act (21 U.S.C. 355(o)(4)) authorizes
FDA to require and, if necessary, order labeling changes if FDA becomes
aware of new safety information that it believes should be included in
the labeling of certain prescription drug and biological products
approved under section 505 of the FD&C Act or section 351 of the Public
Health Service Act (PHS Act) (42 U.S.C. 262). Section 505(o)(4) of the
FD&C Act applies to prescription drug products with an approved new
drug application (NDA) under section 505(b) of the FD&C Act, biological
products with an approved biologics license application under section
351 of the PHS Act, or prescription drug products with an approved
abbreviated new drug application under section 505(j) of the FD&C Act
if the reference listed drug with an approved NDA is not currently
marketed. Section 505(o)(4) imposes time frames for application holders
to submit, and FDA staff to review, such changes and gives FDA
enforcement tools to bring about timely and appropriate labeling
changes. To implement these provisions we developed the guidance
entitled ``Guidance for Industry: Safety Labeling Changes--
Implementation of Section 505(o)(4) of the Federal Food, Drug, and
Cosmetic Act,'' which provides instruction on: (1) A description of the
types of safety labeling changes that ordinarily might be required; (2)
how FDA plans to determine what constitutes new safety information; (3)
the procedures involved in requiring safety labeling changes, and (4)
enforcement of the requirements for safety labeling changes. The
guidance is available on our website at https://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm250783.pdf.
FDA requires safety labeling changes by sending a notification
letter to the application holder. Under section 505(o)(4)(B) of the
FD&C Act, the application holder must respond to FDA's notification by
submitting a labeling supplement or notifying FDA that the applicant
does not believe the labeling change is warranted and by submitting a
statement detailing why the application holder does not believe a
change is warranted (a rebuttal statement).
Based on our experience to date with safety labeling changes
requirements under section 505(o)(4) of the FD&C Act, we estimate that
approximately 36 application holders will elect to submit approximately
1 rebuttal statement each year and that each rebuttal statement will
take approximately 6 hours to prepare.
In addition, the guidance explains that labeling prepared in
response to a safety labeling change notification should be available
on the application holder's website within 10 calendar days of
approval. We estimate that approximately 351 application holders will
post new labeling one time each year in response to a safety labeling
change notification and that the posting of the labeling will take
approximately 4 hours to prepare.
We estimate the burden of the information collection as follows:
Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
Activity Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
--------------------------------------------------------------------------------------------------------------------------------------------------------
Rebuttal statement................................................. 36 1 36 6 216
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
Table 2--Estimated Annual Third-Party Disclosure Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
Type of submission Number of disclosures per Total annual Average burden Total hours
respondents respondent disclosures per disclosure
--------------------------------------------------------------------------------------------------------------------------------------------------------
Posting approved labeling on application holder's website.......... 351 1 351 4 1,404
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
We have adjusted our estimated annual number of respondents
downward by 62 since the last OMB approval of the information
collection. The decrease reflects that we have issued fewer safety
labeling notifications, and thus fewer postings are required and fewer
rebuttals are expected.
Dated: February 6, 2019.
Lowell J. Schiller,
Acting Associate Commissioner for Policy.
[FR Doc. 2019-01918 Filed 2-11-19; 8:45 am]
BILLING CODE 4164-01-P
