[Federal Register Volume 83, Number 208 (Friday, October 26, 2018)]
[Notices]
[Pages 54110-54112]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-23422]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0902]


Agency Information Collection Activities; Proposed Collection; 
Comment Request; Prescription Drug Product Labeling; Medication Guide 
Requirements

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

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 regulations requiring distribution of 
patient labeling, called Medication Guides, for certain products that 
pose a serious and significant public health concern.

DATES: Submit either electronic or written comments on the collection 
of information by December 26, 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 December 26, 2018. The https://www.regulations.gov electronic filing system will accept comments until 
11:59 p.m. Eastern Time at the end of December 26, 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-2011-N-0902 for ``Agency Information Collection Activities; 
Proposed Collection; Comment Request; Prescription Drug Product 
Labeling; Medication Guide Requirements.'' 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 both copies to the Dockets Management Staff. If you do not wish 
your name and

[[Page 54111]]

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.

Prescription Drug Product Labeling; Medication Guide Requirements

OMB Control Number 0910-0393-Extension

    FDA regulations require the distribution of patient labeling, 
called Medication Guides, for certain prescription human drug and 
biological products used primarily on an outpatient basis that pose a 
serious and significant public health concern. Medication Guides 
provide patients the most important information about drug products, 
including the drugs' approved uses, contraindications, adverse drug 
reactions, and cautions for specific populations. These regulations are 
intended to improve the public health by providing information 
necessary for patients to use certain medications safely and 
effectively.
    The regulations contain the following reporting requirements that 
are subject to the PRA:
     21 CFR 208.20--Applicants must submit draft Medication 
Guides for FDA approval according to the prescribed content and format.
     21 CFR 314.70(b)(3)(ii) and 21 CFR 601.12(f)--Application 
holders must submit changes to Medication Guides as supplements to 
their applications to FDA for approval.
     21 CFR 208.24(c)--Each distributor or packer who receives 
Medication Guides, or the means to produce Medication Guides, from a 
manufacturer under paragraph (b) of this section shall provide those 
Medication Guides to each authorized dispenser to whom it ships a drug 
product.
     21 CFR 208.24(e)--Each authorized dispenser of a 
prescription drug product for which a Medication Guide is required must 
provide a Medication Guide directly to each patient when dispensing the 
product to the patient or to the patient's agent, unless an exemption 
applies under 21 CFR 208.26.
     21 CFR 208.26(a)--Requests may be submitted for an 
exemption or a deferral from particular Medication Guide content or 
format requirements.
    FDA estimates the burden of this collection of information as 
follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                     Number of
         21 CFR section              Number of     responses per   Total annual   Average burden    Total hours
                                    respondents     respondent       responses     per response
----------------------------------------------------------------------------------------------------------------
Content and Format of a                       61               1              61             320          19,520
 Medication Guide--Sec.   208.20
Supplements and Other Changes to             155               1             155              72          11,160
 an Approved Application--Sec.
 Sec.   314.70(b)(3)(ii) and
 601.12(f)......................
Exemptions and Deferrals--Sec.                 1               1               1               4               4
 208.26(a)......................
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............          30,684
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.


                           Table 2--Estimated Annual Third-Party Disclosure Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                    Number of
        21 CFR section             Number of     disclosures per   Total annual   Average burden    Total hours
                                  respondents      respondent       disclosures   per disclosure
----------------------------------------------------------------------------------------------------------------
Distributing Medication Guide              191             9,000       1,719,000            1.25       2,148,750
 to Authorized Dispenser--Sec.
   208.24(c)..................

[[Page 54112]]

 
Distributing and Dispensing a           88,736             5,705     506,238,880          * 0.05      25,311,944
 Medication Guide to Patient--
 Sec.   208.24(e).............
                               ---------------------------------------------------------------------------------
    Total.....................  ..............  ................  ..............  ..............      27,460,694
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.
* 3 minutes.

    Our estimated annual reporting burden for the information 
collection reflects an increase of 51 respondents and responses and a 
corresponding overall increase of 4,664 total hours. We attribute this 
adjustment to an increase in the number of submissions we received over 
the last few years. Based on a review of the information collection 
since our last request for OMB approval, we have made no adjustments to 
our annual third-party disclosure burden estimate, except for 
correction in calculations.

    Dated: October 22, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-23422 Filed 10-25-18; 8:45 am]
 BILLING CODE 4164-01-P