[Federal Register Volume 83, Number 140 (Friday, July 20, 2018)]
[Notices]
[Pages 34596-34598]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-15512]


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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 or Agency) is announcing 
an opportunity for public comment on the proposed collection of certain 
information by the Agency. Under the Paperwork Reduction Act of 1995 
(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 September 18, 2018.

ADDRESSES: You may submit comments as follows. Please note that late, 
untimely filed comments will not be considered. Electronic comments 
must be submitted on or before September 18, 2018. The https://www.regulations.gov electronic filing system will accept comments until 
midnight Eastern Time at the end of September 18, 2018. Comments 
received by mail/hand delivery/courier (for written/paper submissions) 
will be considered timely if they are postmarked or the delivery 
service acceptance receipt is on or before that date.

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper 
submissions): Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets 
Management Staff, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2008-N-0500 for ``Agency Information Collection Activities; 
Proposed Collection; Comment Request; Requirements on Content and 
Format of Labeling for Human Prescription Drug and Biological 
Products.'' Received comments, those filed in a timely manner (see 
ADDRESSES), will be placed in the docket and, except for those 
submitted as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. 
and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on https://www.regulations.gov. 
Submit

[[Page 34597]]

both copies to the Dockets Management Staff. If you do not wish your 
name and contact information to be made publicly available, you can 
provide this information on the cover sheet and not in the body of your 
comments and you must identify this information as ``confidential.'' 
Any information marked as ``confidential'' will not be disclosed except 
in accordance with 21 CFR 10.20 and other applicable disclosure law. 
For more information about FDA's posting of comments to public dockets, 
see 80 FR 56469, September 18, 2015, or access the information at: 
https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Ila S. Mizrachi, Office of Operations, 
Food and Drug Administration, Three White Flint North, 10A-12M, 11601 
Landsdown St., North Bethesda, MD 20852, 301-796-7726, 
[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 content and format of labeling for 
human prescription drug and biological products were revised in the 
Federal Register of January 24, 2006 (71 FR 3922) (the 2006 labeling 
rule) 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 because of 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 a 
``Highlights of Prescribing Information'' section. The ``Highlights'' 
section 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 will take applicants approximately 
2,327 hours to design, test, and submit prescription drug labeling to 
FDA as part of a NDA or a BLA under the revised regulations. Currently, 
approximately 406 applicants submit approximately 541 new applications 
(NDAs and BLAs) to FDA annually, totaling 1,258,907 hours.
    FDA estimates the burden of this collection of information as 
follows:

[[Page 34598]]



                                                     Table 1--Estimated Annual Reporting Burden \1\
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                                                                                         Number of
                      21 CFR part and activity                          Number of      responses per     Total annual    Average burden    Total hours
                                                                       respondents     respondent \2\     responses       per response
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Labeling Requirements in Sec.  Sec.   201.56 and 201.57............             406            1.332              541            2,327        1,258,907
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
\2\ Estimates may not sum due to rounding.

    Our estimated burden for the information collection reflects an 
overall increase of 602,503 hours and a corresponding increase of 345 
records. We attribute this adjustment to an increase in the number of 
submissions we received over the last few years.

    Dated: July 16, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-15512 Filed 7-19-18; 8:45 am]
 BILLING CODE 4164-01-P


