[Federal Register Volume 83, Number 101 (Thursday, May 24, 2018)]
[Notices]
[Pages 24127-24128]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-11113]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Prescription Drug 
Marketing; Administrative Procedures, Policies, and Requirements

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing that a 
proposed collection of information has been submitted to the Office of 
Management and Budget (OMB) for review and clearance under the 
Paperwork Reduction Act of 1995.

DATES: Fax written comments on the collection of information by June 
25, 2018.

ADDRESSES: To ensure that comments on the information collection are 
received, OMB recommends that written comments be faxed to the Office 
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, 
Fax: 202-395-7285, or emailed to [email protected]. All 
comments should be identified with the OMB control number 0910-0435. 
Also include the FDA docket number found in brackets in the heading of 
this document.

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: In compliance with 44 U.S.C. 3507, FDA has 
submitted the following proposed collection of information to OMB for 
review and clearance.

Prescription Drug Marketing Act of 1987--Administrative Procedures, 
Policies, and Requirements

OMB Control Number 0910-0435--Extension

    This information collection supports FDA regulations codified at 
part 203 (21 CFR part 203) implementing 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 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 Federal Register of December 14, 2017 (82 FR 58808), we 
published a notice soliciting public comment of the information 
collection. One caller responded to the notice asking about the impact 
the Drug Supply Chain Security Act (DSCSA) (Title II of the Drug 
Quality Security Act of 2013) has on the information collection. We 
note that the Agency is currently proposing to amend its regulations at 
part 203 to reflect changes resulting from enactment of the DSCSA (RIN 
0910-AH56). While we expect these changes will result in a reduction of 
burden associated with the information collection, current regulations 
and associated information collection requirements remain in effect. 
Upon finalization of rulemaking, we will revise the information 
collection accordingly.
    We therefore estimate the burden for the information collection as 
follows:

[[Page 24128]]



                                 Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                    Number of
    21 CFR section/a ctivity        Number of     responses per   Total annual    Average burden    Total hours
                                   respondents     respondent       responses      per response
----------------------------------------------------------------------------------------------------------------
203.11--Reimportation..........               1               1               1  0.5 (30                       1
                                                                                  minutes).
203.30(a)(1) and (b)--Drug               61,961              12         743,532  0.06 (4                  44,612
 sample requests.                                                                 minutes).
203.30(a)(3), (a)(4), and (c)--          61,961              12         743,532  0.06 (4                  44,612
 Drug sample receipts.                                                            minutes).
203.31(a)(1) and (b)--Drug              232,355             135      31,367,925  0.04 (2.5             1,254,717
 sample requests.                                                                 minutes).
203.31(a)(3), (a)(4), and (c)--         232,355             135      31,367,925  0.03 (2                 941,038
 Drug sample receipts.                                                            minutes).
203.37(a)--Falsification of                  50               4             200  0.25 (15                     50
 records.                                                                         minutes).
203.37(b)--Loss or theft of                  50              40           2,000  0.25 (15                    500
 samples.                                                                         minutes).
203.37(c)--Convictions.........               1               1               1  1..............               1
203.37(d)--Contact person......              50               1              50  0.08 (5                       4
                                                                                  minutes).
203.39(g)--Reconciliation                     1               1               1  1..............               1
 report.
                                --------------------------------------------------------------------------------
    Total......................  ..............  ..............  ..............  ...............       2,285,536
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.


                               Table 2--Estimated Annual Recordkeeping Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                    Number of                     Average burden
    21 CFR Section/Activity         Number of      records per    Total annual         per          Total hours
                                  recordkeepers   recordkeeper       records      recordkeeping
----------------------------------------------------------------------------------------------------------------
203.23(a) and (b)--Returned              31,676               5         158,380  0.25 (15                 39,595
 drugs.                                                                           minutes).
203.23(c)--Returned drugs                31,676               5         158,380  0.08 (5                  12,670
 documentation.                                                                   minutes).
203.30(a)(2) and 203.31(a)(2)--           2,208             100         220,800  0.5 (30                 110,400
 Practitioner verification.                                                       minutes).
203.31(d)(1) and (2)--Inventory           2,208               1           2,208  40.............          88,320
 record and reconciliation
 report.
203.31(d)(4)--Investigation of              442               1             442  24.............          10,608
 discrepancies and losses.
203.31(e)--Representatives                2,208               1           2,208  1..............           2,208
 lists.
203.34--Administrative systems.              90               1              90  40.............           3,600
203.37(a)--Falsification of                  50               4             200  6..............           1,200
 drug sample records.
203.37(b)--Loss or theft of                  50              40           2,000  6..............          12,000
 drug samples.
203.39(d)--Destroyed or                      65               1              65  1..............              65
 returned drug samples.
203.39(e)--Donated drug samples           3,221               1           3,221  0.5 (30                   1,611
                                                                                  minutes).
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                      125             100          12,500  0.17 (10                  2,125
 statement.                                                                       minutes).
203.50(b)--Drug origin                      125             100          12,500  0.5 (30                   6,250
 statement retention.                                                             minutes).
203.50(d)--Authorized                       691               1             691  2..............           1,382
 distributors of record.
                                --------------------------------------------------------------------------------
    Total......................  ..............  ..............  ..............  ...............         343,570
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    Based on a review of Agency data, we retain the currently approved 
burden estimate for the information collection, as reflected in tables 
1 and 2 above.

    Dated: May 18, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-11113 Filed 5-23-18; 8:45 am]
 BILLING CODE 4164-01-P


