Document ID: FDA-2011-N-0883-0001
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: 2011-12-19T05:00Z

[Federal Register Volume 76, Number 243 (Monday, December 19, 2011)]
[Notices]
[Pages 78668-78669]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-32397]

[[Page 78668]]

-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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, (301) 796-7651, 
Juanmanuel.Vilela@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 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

[[Page 78669]]

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\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                  Number of
                Category (21 CFR section)                      Number of        responses  per      Total annual      Average burden      Total hours
                                                              respondents         respondent         responses         per response
--------------------------------------------------------------------------------------------------------------------------------------------------------
Annual Burden for Labeling Requirements in Sec.  Sec.                    84               1.25                105              3,349            351,645
 201.56 and 201.57.......................................
--------------------------------------------------------------------------------------------------------------------------------------------------------
\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