
[Federal Register Volume 80, Number 13 (Wednesday, January 21, 2015)]
[Notices]
[Pages 2943-2945]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2015-00761]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


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

[[Page 2944]]

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 March 23, 2015.

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: 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: 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 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.
    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:

[[Page 2945]]



                                 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.                131             1.5             196           3,349         656,404
 Sec.   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: January 13, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-00761 Filed 1-20-15; 8:45 am]
BILLING CODE 4164-01-P


