Document ID: FDA-2011-N-0279-0007
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Proposed Collection; Comment Request; Prescription Drug Marketing Act of 1987; Administrative  Procedures, Policies, and Requirements
Posted Date: 2017-12-14T05:00Z

[Federal Register Volume 82, Number 239 (Thursday, December 14, 2017)]
[Notices]
[Pages 58808-58810]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-26933]

=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0279]

Agency Information Collection Activities; Proposed Collection; 
Comment Request; Prescription Drug Marketing Act of 1987; 
Administrative Procedures, Policies, and 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 the information collection in the 
regulations on the Prescription Drug Marketing Act of 1987; 
Administrative Procedures, Policies, and Requirements.

DATES: Submit either electronic or written comments on the collection 
of information by February 12, 2018.

ADDRESSES: You may submit comments as follows. Please note that late, 
untimely filed comments will not be considered. Electronic comments 
must

[[Page 58809]]

be submitted on or before February 12, 2018. The https://www.regulations.gov electronic filing system will accept comments until 
midnight Eastern Time at the end of February 12, 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-0279 for ``Agency Information Collection Activities; 
Proposed Collection; Comment Request; Prescription Drug Marketing Act 
of 1987; Administrative Procedures, Policies, and 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 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: Domini Bean, Office of Operations, 
Food and Drug Administration, Three White Flint North, 10A-12M, 11601 
Landsdown St., North Bethesda, MD 20852, 301-796-5733, 
[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 Marketing Act of 1987--Administrative Procedures, 
Policies, and Requirements

OMB Control Number 0910-0435--Extension

    This information collection supports FDA regulations. Specifically, 
regulations codified at 21 CFR part 203 implement the Prescription Drug 
Marketing Act of 1987 (PDMA). The PDMA was intended to ensure safe and 
effective drug products and to avoid an unacceptable risk that 
counterfeit, adulterated, misbranded, subpotent, or expired drugs are 
sold to consumers. The reporting and recordkeeping requirements found 
in the regulations are intended to help achieve the following goals: 
(1) To ban the reimportation of prescription drugs produced in the 
United States, except when reimported by the manufacturer or under FDA 
authorization for emergency medical care; (2) to ban the sale, 
purchase, or trade, or the offer to sell, purchase, or trade, of any 
prescription drug sample; (3) to limit the distribution of drug samples 
to practitioners licensed or authorized to prescribe such drugs or to 
pharmacies of

[[Page 58810]]

hospitals or other healthcare entities at the request of a licensed or 
authorized practitioner; (4) to require licensed or authorized 
practitioners to request prescription drug samples in writing; (5) to 
mandate storage, handling, and recordkeeping requirements for 
prescription drug samples; (6) to prohibit, with certain exceptions, 
the sale, purchase, or trade, or the offer to sell, purchase, or trade, 
of prescription drugs that were purchased by hospitals or other 
healthcare entities or that were donated or supplied at a reduced price 
to a charitable organization; and (7) to require unauthorized wholesale 
distributors to provide, prior to the wholesale distribution of a 
prescription drug to another wholesale distributor or retail pharmacy, 
a statement identifying each prior sale, purchase, or trade of the 
drug. In the tables below we have listed specific regulatory provisions 
that include information collection.
    We estimate the burden of the information collection as follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                                                      Average
                                     Number of       Number of     Total annual     burden per
     21 CFR section/activity        respondents    responses per     responses     response  (in    Total hours
                                                    respondent                        hours)
----------------------------------------------------------------------------------------------------------------
203.11--Reimportation...........               1               1               1             0.5               1
203.30(a)(1) and (b)--Drug                61,961              12         743,532            0.06          44,612
 sample requests................
203.30(a)(3), (a)(4), and (c)--           61,961              12         743,532            0.06          44,612
 Drug sample receipts...........
203.31(a)(1) and (b)--Drug               232,355             135      31,367,925            0.04       1,254,717
 sample requests................
203.31(a)(3), (a)(4), and (c)--          232,355             135      31,367,925            0.03         941,038
 Drug sample receipts...........
203.37(a)--Falsification of                   50               4             200            0.25              50
 records........................
203.37(b)--Loss or theft of                   50              40           2,000            0.25             500
 samples........................
203.37(c)--Convictions..........               1               1               1               1               1
203.37(d)--Contact person.......              50               1              50            0.08               4
203.39(g)--Reconciliation report               1               1               1               1               1
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............       2,285,536
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

                               Table 2--Estimated Annual Recordkeeping Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                                                  Average burden
                                     Number of       Number of     Total annual         per
     21 CFR section/activity       recordkeepers    records per       records      recordkeeping    Total hours
                                                   recordkeeper                     (in hours)
----------------------------------------------------------------------------------------------------------------
203.23(a) and (b)--Returned               31,676               5         158,380            0.25          39,595
 drugs..........................
203.23(c)--Returned drugs                 31,676               5         158,380            0.08          12,670
 documentation..................
203.30(a)(2) and 203.31(a)(2)--            2,208             100         220,800             0.5         110,400
 Practitioner verification......
203.31(d)(1) and (d)(2)--                  2,208               1           2,208              40          88,320
 Inventory record and
 reconciliation report..........
203.31(d)(4)--Investigation of               442               1             442              24          10,608
 discrepancies and losses.......
203.31(e)--Representatives lists           2,208               1           2,208               1           2,208
203.34--Administrative systems..              90               1              90              40           3,600
203.37(a)--Falsification of drug              50               4             200               6           1,200
 sample records.................
203.37(b)--Loss or theft of drug              50              40           2,000               6          12,000
 samples........................
203.39(d)--Destroyed or returned              65               1              65               1              65
 drug samples...................
203.39(e)--Donated drug samples.           3,221               1           3,221             0.5           1,611
203.39(f)--Distribution of                 3,221               1           3,221               8          25,768
 donated drug samples...........
203.39(g)--Drug samples donated            3,221               1           3,221               8          25,768
 to charitable institutions.....
203.50(a)--Drug origin statement             125             100          12,500            0.17           2,125
203.50(b)--Drug origin statement             125             100          12,500             0.5           6,250
 retention......................
203.50(d)--Authorized                        691               1             691               2           1,382
 distributors of record.........
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............         343,570
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    Based on a review of the information collection, we have retained 
the currently approved estimated burden.

    Dated: December 8, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-26933 Filed 12-13-17; 8:45 am]
 BILLING CODE 4164-01-P