Document ID: FDA-2018-N-4735-0001
Agency: fda
Document Type: Notice
Title: 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
Posted Date: 2019-02-12T05:00Z

[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]

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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.

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[[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\
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                                                                                         Number of
                              Activity                                  Number of      responses per     Total annual    Average burden    Total hours
                                                                       respondents       respondent       responses       per response
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Rebuttal statement.................................................              36                1               36                6              216
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\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\
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                                                                                         Number of
                         Type of submission                             Number of     disclosures per    Total annual    Average burden    Total hours
                                                                       respondents       respondent      disclosures     per disclosure
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Posting approved labeling on application holder's website..........             351                1              351                4            1,404
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\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