Document ID: FDA-2018-N-4735-0005
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Safety Labeling Changes—Implementation of Section 505(o)(4) of the Federal Food, Drug, and Cosmetic Act
Posted Date: 2019-06-10T04:00Z

[Federal Register Volume 84, Number 111 (Monday, June 10, 2019)]
[Notices]
[Pages 26880-26882]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-12109]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-N-4735]

Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; 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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SUMMARY: The Food and Drug Administration (FDA) is announcing that a 
proposed collection of information has been submitted to the

[[Page 26881]]

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 July 
10, 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 0910-0734. 
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.

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 Federal Food, Drug, and Cosmetic Act (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) establishes time frames by which application holders must 
submit, and FDA staff must review, information necessary to ensure 
timely and appropriate labeling changes. To communicate how we 
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 currently posted to the docket and available on FDA's 
website at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/safety-labeling-changes-implementation-section-505o4-federal-food-drug-and-cosmetic-act.
    As explained in the guidance, we send application holders a 
notification letter when safety labeling changes are required. Under 
section 505(o)(4)(B) of the FD&C Act, the application holder must 
respond to our notification by either submitting a labeling supplement, 
or a rebuttal statement explaining why it believes the labeling change 
is unwarranted. Based on our experience to date with safety labeling 
changes requirements under section 505(o)(4) of the FD&C Act, we 
estimate that 36 application holders will elect to submit 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 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.
    In the Federal Register of February 12, 2019 (84 FR 3461), we 
published a 60-day notice requesting public comment on the proposed 
collection of information. One comment was received. The comment 
offered general support for the information collection, provided 
certain statistical details regarding potential respondents, encouraged 
utilization of electronic and/or digital technology where possible, and 
offered a related topic for which additional guidance might be useful. 
We appreciate the comment and will continue to consider the suggestions 
provided. At the same time, it was not suggested that we make changes 
to our burden estimate, which remains 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 approval 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.

    Since last OMB review and approval, we have adjusted our estimated 
annual number of respondents downward by 62. The decrease reflects that 
we have issued fewer safety labeling notifications, and thus fewer 
postings

[[Page 26882]]

are required and fewer rebuttals are expected.

    Dated: June 3, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-12109 Filed 6-7-19; 8:45 am]
 BILLING CODE 4164-01-P