[Federal Register Volume 80, Number 13 (Wednesday, January 21, 2015)]
[Notices]
[Pages 2943-2945]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-00761]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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, [email protected].
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\
----------------------------------------------------------------------------------------------------------------
Number of
21 CFR Part Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
----------------------------------------------------------------------------------------------------------------
Labeling Requirements in Sec. 131 1.5 196 3,349 656,404
Sec. 201.56 and 201.57.......
----------------------------------------------------------------------------------------------------------------
---------------------------------------------------------------------------
\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