[Federal Register Volume 76, Number 243 (Monday, December 19, 2011)]
[Notices]
[Pages 78668-78669]
[FR Doc No: 2011-32397]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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

Agency Information Collection Activities; Proposed Collection;
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 an
opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(the 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 the information collection
provisions of FDA's requirements on content and format of labeling for
human prescription drug and biological products.

DATES: Submit either electronic or written comments on the collection
of information by February 17, 2012.

ADDRESSES: Submit electronic comments on the collection of information
to http://www.regulations.gov. Submit written comments on the
collection of information to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061,
Rockville, MD 20852. All comments should be identified with the 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,<PHONE_NUMBER>,
<EMAIL_ADDRESS>
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.

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 paragraphs, 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 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 multi-
year period. We are requesting that OMB extend approval for the
information in this collection, as described below, which will continue
to be submitted to FDA during this multi-year 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.
    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
                Category (21 CFR section)                      Number of        responses  per      Total annual      Average burden      Total hours
                                                              respondents         respondent         responses         per response
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Annual Burden for Labeling Requirements in Sec.  Sec.                    84               1.25                105              3,349            351,645
 201.56 and 201.57.......................................
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    Dated: December 14, 2011.
David Dorsey,
Acting Associate Commissioner for Policy and Planning.
[FR Doc. 2011-32397 Filed 12-16-11; 8:45 am]
BILLING CODE 4160-01-P