[Federal Register Volume 74, Number 55 (Tuesday, March 24, 2009)]
[Notices]
[Pages 12365-12368]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-6394]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-N-0664]


Agency Information Collection Activities; Proposed Collection; 
Comment Request; Prescription Drug Marketing Act of 1987

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing an

[[Page 12366]]

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 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 reporting and 
recordkeeping requirements contained in the regulations implementing 
the Prescription Drug Marketing Act of 1987 (PDMA) (Public Law 100-
293).

DATES: Submit written or electronic comments on the collection of 
information by May 26, 2009.

ADDRESSES: Submit electronic comments on the collection of information 
to http://www.regulations.gov. Submit written comments on the 
collection of information to the Dockets Management Branch (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: Elizabeth Berbakos, Office of 
Information Management (HFA-710), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-796-3792.

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; 21 CFR Part 203 (OMB Control Number 0910-
0435)--Extension

    FDA is requesting OMB approval under the Paperwork Reduction Act 
(44 USC 3501-3520) for the reporting and recordkeeping requirements 
contained in the regulations implementing the PDMA. PDMA was intended 
to ensure that drug products purchased by consumers are safe and 
effective and to avoid an unacceptable risk that counterfeit, 
adulterated, misbranded, subpotent, or expired drugs are sold.
    PDMA was enacted by Congress because there were insufficient 
safeguards in the drug distribution system to prevent the introduction 
and retail sale of substandard, ineffective, or counterfeit drugs, and 
that a wholesale drug diversion submarket had developed that prevented 
effective control over the true sources of drugs.
    Congress found that large amounts of drugs had been reimported into 
the United States as U.S. goods returned causing a health and safety 
risk to U.S. consumers because the drugs may become subpotent or 
adulterated during foreign handling and shipping. Congress also found 
that a ready market for prescription drug reimports had been the 
catalyst for a continuing series of frauds against U.S. manufacturers 
and had provided the cover for the importation of foreign counterfeit 
drugs.
    Congress also determined that the system of providing drug samples 
to physicians through manufacturers' representatives had resulted in 
the sale to consumers of misbranded, expired, and adulterated 
pharmaceuticals.The bulk resale of below-wholesale priced prescription 
drugs by health care entities for ultimate sale at retail also helped 
to fuel the diversion market and was an unfair form of competition to 
wholesalers and retailers who had to pay otherwise prevailing market 
prices.
    FDA is requesting OMB approval for the following reporting and 
recordkeeping requirements:

                         REPORTING REQUIREMENTS
------------------------------------------------------------------------
 
------------------------------------------------------------------------
21 CFR 203.11         Applications for reimportation to provide
                       emergency medical care.
------------------------------------------------------------------------

21 CFR 203.30(a)(1)   Drug sample requests (drug samples distributed by
 and (b)               mail or common carrier).
------------------------------------------------------------------------
21 CFR                Drug sample receipts (receipts for drug samples
 203.30(a)(3),(a)(4)   distributed by mail or common carrier).
 and (c)
------------------------------------------------------------------------
21 CFR 203.31(a)(1)   Drug sample requests (drug samples distributed by
 and (b)               means other than the mail or a common carrier).
------------------------------------------------------------------------
21 CFR                Drug sample receipts (drug samples distributed by
 203.31(a)(3),(a)(4)   means other than the mail or a common carrier).
 and (c)
------------------------------------------------------------------------
21 CFR 203.37(a)      Investigation of falsification of drug sample
                       records.
------------------------------------------------------------------------
21 CFR 203.37(b)      Investigation of a significant loss or known theft
                       of drug samples.
------------------------------------------------------------------------
21 CFR 203.37(c)      Notification that a representative has been
                       convicted of certain offenses involving drug
                       samples.
------------------------------------------------------------------------
21 CFR 203.37(d)      Notification of the individual responsible for
                       responding to a request for information about
                       drug samples.
------------------------------------------------------------------------
21 CFR 203.39(g)      Preparation by a charitable institution of a
                       reconciliation report for donated drug samples.
------------------------------------------------------------------------


[[Page 12367]]


                       RECORDKEEPING REQUIREMENTS
------------------------------------------------------------------------
 
------------------------------------------------------------------------
21 CFR 203.23(a) and  Credit memo for returned drugs.
 (b)
------------------------------------------------------------------------
21 CFR 203.23(c)      Documentation of proper storage, handling, and
                       shipping conditions for returned drugs.
------------------------------------------------------------------------
21 CFR 203.30(a)(2)   Verification that a practitioner requesting a drug
and 21 CFR             sample is licensed or authorized by the
 203.31(a)(2)          appropriate State authority to prescribe the
                       product.
------------------------------------------------------------------------
21 CFR 203.31(d)(1)   Contents of the inventory record and
 and (d)(2)            reconciliation report required for drug samples
                       distributed by representatives.
------------------------------------------------------------------------
21 CFR 203.31(d)(4)   Investigation of apparent discrepancies and
                       significant losses revealed through the
                       reconciliation report.
------------------------------------------------------------------------
21 CFR 203.31(e)      Lists of manufacturers' and distributors'
                       representatives.
------------------------------------------------------------------------
21 CFR 203.34         Written policies and procedures describing
                       administrative systems.
------------------------------------------------------------------------
21 CFR 203.37(a)      Report of investigation of falsification of drug
                       sample records.
------------------------------------------------------------------------
21 CFR 203.37(b)      Report of investigation of significant loss or
                       known theft of drug samples.
------------------------------------------------------------------------
21 CFR 203.38(b)      Records of drug sample distribution identifying
                       lot or control numbers of samples distributed.
                       (The information collection in 21 CFR 203.38(b)
                       is already approved under OMB Control Number 0910-
                       0139).
------------------------------------------------------------------------
21 CFR 203.39(d)      Records of drug samples destroyed or returned by a
                       charitable institution.
------------------------------------------------------------------------
21 CFR 203.39(e)      Record of drug samples donated to a charitable
                       institution.
------------------------------------------------------------------------
21 CFR 203.39(f)      Records of donation and distribution or other
                       disposition of donated drug samples.
------------------------------------------------------------------------
21 CFR 203.39(g)      Inventory and reconciliation of drug samples
                       donated to charitable institutions.
------------------------------------------------------------------------
21 CFR 203.50(a)      Drug origin statement.
------------------------------------------------------------------------
21 CFR 203.50(b)      Retention of drug origin statement for 3 years.
------------------------------------------------------------------------
21 CFR 203.50(d)      List of authorized distributors of record.
------------------------------------------------------------------------

    The reporting and recordkeeping requirements are intended to help 
achieve the following goals:
    (1) To ban the reimportation of prescription drugs produced in the 
U.S., 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 health care 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 of, or the offer to sell, purchase, or trade, prescription drugs 
that were purchased by hospitals or other health care entities, or 
which were donated or supplied at a reduced price to a charitable 
organization;
    (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.
    FDA estimates the burden of this collection of information as 
follows:

                                 Table 1.--Estimated Annual Reporting Burden\1\
----------------------------------------------------------------------------------------------------------------
                         No. of       Annual  Frequency     Total Annual        Hours per
  21 CFR Section      Respondents        per Response        Responses           Response         Total Hours
----------------------------------------------------------------------------------------------------------------
203.11                             1                  1                  1                 .5                0.5
----------------------------------------------------------------------------------------------------------------
203.30(a)(1) and              61,961                 12            743,532                .06             44,612
 (b)
----------------------------------------------------------------------------------------------------------------
203.30(a)(3),                 61,961                 12            743,532                .06             44,612
 (a)(4) and (c)
----------------------------------------------------------------------------------------------------------------
203.31(a)(1) and             232,355                135         31,367,925                .04          1,254,717
 (b)
----------------------------------------------------------------------------------------------------------------
203.31(a)(3),                232,355                135         31,367,925                .03            941,038
 (a)(4) and (c)
----------------------------------------------------------------------------------------------------------------
203.37(a)                         50                  4                200                .25                 50
----------------------------------------------------------------------------------------------------------------

[[Page 12368]]

 
203.37(b)                         50                 40              2,000                .25                500
----------------------------------------------------------------------------------------------------------------
203.37(c)                          1                  1                  1                  1                  1
----------------------------------------------------------------------------------------------------------------
203.37(d)                         50                  1                 50                .08                  4
----------------------------------------------------------------------------------------------------------------
203.39(g)                          1                  1                  1                  1                  1
----------------------------------------------------------------------------------------------------------------
Total              .................  .................  .................  .................       2,285,535.50
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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\
----------------------------------------------------------------------------------------------------------------
                                       Annual Frequency
  21 CFR Section         No. of              per            Total Annual    Hours per  Record     Total Hours
                     Recordkeepers      Recordkeeping         Records
----------------------------------------------------------------------------------------------------------------
203.23(a) and (b)             31,676                  5            158,380                .25             39,595
----------------------------------------------------------------------------------------------------------------
203.23(c)                     31,676                  5            158,380                .08             12,670
----------------------------------------------------------------------------------------------------------------
203.30(a)(2) and               2,208                100            220,800                .50            110,400
 203.31(a)(2)
----------------------------------------------------------------------------------------------------------------
203.31(d)(1) and               2,208                  1              2,208                 40             88,320
 (d)(2)
----------------------------------------------------------------------------------------------------------------
203.31(d)(4)                     442                  1                442                 24             10,608
----------------------------------------------------------------------------------------------------------------
203.31(e)                      2,208                  1              2,208                  1              2,208
----------------------------------------------------------------------------------------------------------------
203.34                            90                  1                 90                 40              3,600
----------------------------------------------------------------------------------------------------------------
203.37(a)                         50                  4                200                  6              1,200
----------------------------------------------------------------------------------------------------------------
203.37(b)                         50                 40              2,000                  6             12,000
----------------------------------------------------------------------------------------------------------------
203.39(d)                         65                  1                 65                  1                 65
----------------------------------------------------------------------------------------------------------------
203.39(e)                      3,221                  1              3,221                .50              1,610
----------------------------------------------------------------------------------------------------------------
203.39(f)                      3,221                  1              3,221                  8             25,768
----------------------------------------------------------------------------------------------------------------
203.39(g)                      3,221                  1              3,221                  8             25,768
----------------------------------------------------------------------------------------------------------------
203.50(a)                          0                  0                  0                  0                  0
----------------------------------------------------------------------------------------------------------------
203.50(b)                          0                  0                  0                  0                  0
----------------------------------------------------------------------------------------------------------------
203.50(d)                          0                  0                  0                  0                  0
----------------------------------------------------------------------------------------------------------------
Total              .................  .................  .................  .................            324,092
----------------------------------------------------------------------------------------------------------------
\1\There are no capital costs or operating and maintenance costs associated with this collection of information.


    Dated: March 17, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E9-6394 Filed 3-23-09; 8:45 am]
BILLING CODE 4160-01-S