Document ID: FDA-2011-N-0883-0002
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Proposals, Submissions, and Approvals: Requirements on Content and Format of Labeling for Human Prescription Drug and Biological Products
Posted Date: 2012-03-20T04:00Z

[Federal Register Volume 77, Number 54 (Tuesday, March 20, 2012)]
[Notices]
[Pages 16234-16235]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-6693]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0883]

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 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 April 
19, 2012.

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: Juanmanuel Vilela, Office of 
Information Management, Food and Drug Administration, 1350 Piccard Dr., 
PI50-400B, Rockville, MD 20850, 301-796-7651, 
Juanmanuel.Vilela@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 final rule entitled ``Requirements on Content and Format of 
Labeling for Human Prescription Drug and Biological Products'' (the 
final rule), which published on January 24, 2006 (71 FR 3922), and was 
effective on June 30, 2006, amended FDA's regulations governing the 
format and content of labeling for human prescription drug and 
biological products 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.

A. Summary of Prescription Drug Labeling Content and Format 
Requirements That Contain Collections of Information

    Section 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

[[Page 16235]]

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 remain subject to labeling requirements at 
Sec.  201.80 (in the final rule, former Sec.  201.57 was redesignated 
as 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.

B. Estimates of Reporting Burden

    The PRA information collection analysis in the final rule (71 FR 
3964-3967) (currently approved under OMB control number 0910-0572) 
estimated the reporting burden for a multiyear period. We are 
requesting that OMB extend approval for the information in this 
collection, as described below that will continue to be submitted to 
FDA during this multiyear period.
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) (Table 1)
    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 estimated in the 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. Approximately 84 
applicants submit approximately 105 new applications (NDAs and BLAs) to 
FDA per year, totaling 351,645 hours.
    In the Federal Register of December 19, 2011 (76 FR 78668), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. FDA received no comments.
    FDA estimates the burden of this collection of information as 
follows:

                        Table 1--Estimated Reporting Burden for New Drug Applications \1\
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                                                     Number of                        Average
   Category  (21 CFR section)        Number of     responses per   Total annual     burden per      Total hours
                                    respondents     respondent       responses       response
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Annual Burden for Labeling                    84            1.25             105           3,349         351,645
 Requirements in Sec.  Sec.
 201.56 and 201.57..............
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    Total.......................  ..............  ..............  ..............  ..............         351,645
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    Dated: March 15, 2012.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2012-6693 Filed 3-19-12; 8:45 am]
BILLING CODE 4160-01-P