Document ID: FDA-2008-N-0500-0004
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Requirements on Content and Format of Labeling for Human Prescription Drug and 
Biological Products
Posted Date: 2015-05-29T04:00Z

[Federal Register Volume 80, Number 103 (Friday, May 29, 2015)]
[Notices]
[Pages 30686-30688]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-12957]

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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; 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

[[Page 30687]]

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 June 
29, 2015.

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 0910-0572. 
Also include the FDA docket number found in brackets in the heading of 
this document.

FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations, 
Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver 
Spring, MD 20993-0002, 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.

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 format and content of labeling for 
human prescription drug and biological products were revised in the 
Federal Register of January 24, 2006 (71 FR 3922), 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 due to 
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 
``Highlights of Prescribing Information.'' ``Highlights'' 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 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.
    In the Federal Register of January 21, 2015 (80 FR 2943), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. FDA received two comments, however, these 
comments did not address the information collection.
    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 takes applicants approximately 3,349 
hours to design, test, and submit prescription drug labeling to FDA as 
part of an NDA or a BLA under the revised regulations. Currently, 
approximately 131 applicants submit approximately 196 new applications 
(NDAs and BLAs) to FDA annually, totaling 656,404 hours.
    FDA estimates the burden of this collection of information as 
follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
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                                                                                         Number of
                            21 CFR Part                                 Number of      responses per     Total annual   Average  burden    Total hours
                                                                       respondents       respondent       responses      per  response
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Labeling Requirements in Sec.  Sec.   201.56 and 201.57............             131              1.5              196            3,349          656,404
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

[[Page 30688]]

    Dated: May 22, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-12957 Filed 5-28-15; 8:45 am]
 BILLING CODE 4164-01-P