Document ID: FDA-2008-N-0500-0009
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Submission for Office of
Management and Budget Review; Comment Request; General Licensing
Provisions; Requirements on Content and Format of Labeling for Human
Prescription Drug and Biological Products
Posted Date: 2018-11-21T05:00Z

[Federal Register Volume 83, Number 225 (Wednesday, November 21, 2018)]
[Notices]
[Pages 58776-58777]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-25352]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-N-0500]

Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; General Licensing 
Provisions; Requirements on Content and Format of Labeling for Human 
Prescription Drug and Biological Products

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 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 
December 21, 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 0910-0572. 
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, 
[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.

Requirements on Content and Format of Labeling for Human Prescription 
Drug and Biological Products

OMB Control Number 0910-0572--Extension

    FDA's regulations governing the content and format of labeling for 
human prescription drug and biological products were revised in the 
Federal Register of January 24, 2006 (71 FR 3922) (the 2006 labeling 
rule) to require that the labeling of new and recently approved 
products contain highlights of prescribing information, a table of 
contents for prescribing information, reordering of certain sections, 
minor content changes, and minimum graphical requirements. These 
revisions were intended to make it easier for health care practitioners 
to access, read, and use information in prescription drug labeling; to 
enhance the safe and effective use of prescription drug products; and 
to reduce the number of adverse reactions resulting from medication 
errors because of misunderstood or incorrectly applied drug 
information.
    Currently, Sec.  201.56 (21 CFR 201.56) requires that prescription 
drug labeling contain certain information in the format specified in 
either Sec.  201.57 (21 CFR 201.57) or Sec.  201.80 (21 CFR 201.80), 
depending on when the drug was approved for marketing. Section 
201.56(a) sets forth general labeling requirements applicable to all 
prescription drugs. Section 201.56(b) specifies the categories of new 
and more recently approved prescription drugs subject to the revised 
content and format requirements in Sec. Sec.  201.56(d) and 201.57. 
Section 201.56(c) sets forth the schedule for implementing these 
revised content and format requirements. Section 201.56(e) specifies 
the sections and subsections, required and optional, for the labeling 
of older prescription drugs not subject to the revised format and 
content requirements.
    Section 201.57(a) requires that prescription drug labeling for new 
and more recently approved prescription drug products include a 
``Highlights of Prescribing Information'' section. The ``Highlights'' 
section provides a concise extract of the most important information 
required under Sec.  201.57(c) (the Full Prescribing Information 
(FPI)), as well as certain additional information important to 
prescribers. Section 201.57(b) requires a table of contents to

[[Page 58777]]

prescribing information entitled ``Full Prescribing Information: 
Contents,'' consisting of a list of each heading and subheading along 
with its identifying number to facilitate health care practitioners' 
use of labeling information. Section 201.57(c) specifies the contents 
of the FPI. Section 201.57(d) mandates the minimum specifications for 
the format of prescription drug labeling and establishes minimum 
requirements for key graphic elements such as bold type, bullet points, 
type size, and spacing.
    Older drugs not subject to the revised labeling content and format 
requirements in Sec.  201.57 are subject to labeling requirements at 
Sec.  201.80. Section 201.80(f)(2) requires that, within 1 year, any 
FDA-approved patient labeling be referenced in the ``Precautions'' 
section of the labeling of older products and either accompany or be 
reprinted immediately following the labeling.
Annual Burden for Prescription Drug Labeling Design, Testing, and 
Submitting to FDA for New Drug Applications (NDAs) and Biologics 
License Applications (BLAs) (Sec. Sec.  201.56 and 201.57)
    New drug product applicants must: (1) Design and create 
prescription drug labeling containing ``Highlights,'' ``Contents,'' and 
FPI; (2) test the designed labeling (e.g., to ensure that the designed 
labeling fits into carton-enclosed products); and (3) submit it to FDA 
for approval. Based on the projected data used in the January 24, 2006, 
final rule, FDA estimates that it will take applicants approximately 
2,327 hours to design, test, and submit prescription drug labeling to 
FDA as part of a NDA or a BLA under the revised regulations. Currently, 
approximately 406 applicants submit approximately 541 new applications 
(NDAs and BLAs) to FDA annually, totaling 1,258,907 hours.
    In the Federal Register of July 20, 2018 (83 FR 34596), we 
published a 60-day notice requesting public comment on the proposed 
collection of information. We received two comments. One comment 
encouraged the use of ``provider-neutral language'' in specific 
regulations. The second comment discussed the distribution of package 
inserts for prescription drugs via paper labeling. Because these 
comments do not apply to the regulations associated with the 
information collection, we have not addressed them here.
    Our estimate of the burden for the information collection is as 
follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
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                                                                                         Number of
                      21 CFR part and activity                          Number of      responses per     Total annual    Average burden    Total hours
                                                                       respondents     respondent \2\     responses       per response
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Labeling Requirements in Sec.  Sec.   201.56 and 201.57............             406            1.332              541            2,327        1,258,907
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
\2\ Estimates may not sum due to rounding.

    Our estimated burden for the information collection reflects an 
overall increase of 602,503 hours and a corresponding increase of 345 
records. We attribute this adjustment to an increase in the number of 
submissions we received over the last few years.

    Dated: November 14, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-25352 Filed 11-20-18; 8:45 am]
BILLING CODE 4164-01-P