[Federal Register Volume 71, Number 51 (Thursday, March 16, 2006)]
[Notices]
[Pages 13599-13602]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-3818]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2006N-0081]


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 
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).

DATES: Submit written or electronic comments on the collection of 
information by May 15, 2006.

ADDRESSES: Submit electronic comments on the collection of information 
to http://www.fda.gov/dockets/ecomments. Submit written comments on the 
collection of information to the Division of Dockets Management (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: Karen Nelson, Office of Management 
Programs (HFA-250), Food and Drug Administration, 5600 Fishers Lane, 
Rockville, MD 20857, 301-827-1482.

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

[[Page 13600]]

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:

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


                  Table 2.--Recordkeeping Requirements
------------------------------------------------------------------------
           21 CFR Section                 Recordkeeping Requirements
------------------------------------------------------------------------
203.23(a) and (b)                    Credit memo for returned drugs
------------------------------------------------------------------------
203.23(c)                            Documentation of proper storage,
                                      handling, and shipping conditions
                                      for returned drugs
------------------------------------------------------------------------
203.30(a)(2) and 203.31(a)(2)        Verification that a practitioner
                                      requesting a drug sample is
                                      licensed or authorized to
                                      prescribe the product
------------------------------------------------------------------------
203.31(d)(1) and (d)(2)              Contents of the inventory record
                                      and reconciliation report required
                                      for drug samples distributed by
                                      representatives
------------------------------------------------------------------------
203.31(d)(4)                         Investigation of apparent
                                      discrepancies and significant
                                      losses revealed through the
                                      reconciliation report
------------------------------------------------------------------------
203.31(e)                            Lists of manufacturers' and
                                      distributors' representatives
------------------------------------------------------------------------
203.34                               Written policies and procedures
                                      describing administrative systems
------------------------------------------------------------------------
203.37(a)                            Report of investigation of
                                      falsification of drug sample
                                      records
------------------------------------------------------------------------
203.37(b)                            Report of investigation of
                                      significant loss or known theft of
                                      drug samples
------------------------------------------------------------------------
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)
------------------------------------------------------------------------
203.39(d)                            Records of drug samples destroyed
                                      or returned by a charitable
                                      institution
------------------------------------------------------------------------
203.39(e)                            Record of drug samples donated to a
                                      charitable institution
------------------------------------------------------------------------

[[Page 13601]]

 
203.39(f)                            Records of donation and
                                      distribution or other disposition
                                      of donated drug samples
------------------------------------------------------------------------
203.39(g)                            Inventory and reconciliation of
                                      drug samples donated to charitable
                                      institutions
------------------------------------------------------------------------
203.50(a)                            Drug origin statement
------------------------------------------------------------------------
203.50(b)                            Retention of drug origin statement
                                      for 3 years
------------------------------------------------------------------------
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 
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 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 3.--Estimated Annual Reporting Burden\1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                        No. of Responses per      Total Annual          Hours per
                 21 CFR Section                    No. of Respondents        Respondent             Responses            Response         Total Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
203.11                                                              12                     1                    12                 .5                  6
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203.30(a)(1) and (b)                                            61,961                    12               743,532                .06             44,612
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203.30(a)(3), (a)(4), and (c)                                   61,961                    12               743,532                .06             44,612
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203.31(a)(1) and (b)                                           232,355                   135            31,367,925                .04          1,254,717
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203.31(a)(3), (a)(4), and (c)                                  232,355                   135            31,367,925                .03            941,038
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203.37(a)                                                           25                     1                    25               6.00                150
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203.37(b)                                                          200                     1                   200               6.00              1,200
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203.37(c)                                                           50                     1                    50               1.00                 50
--------------------------------------------------------------------------------------------------------------------------------------------------------
203.37(d)                                                        2,208                     1                 2,208                .08                177
--------------------------------------------------------------------------------------------------------------------------------------------------------
203.39(g)                                                        3,221                     1                 3,221               2.00              6,442
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Total Reporting Burden Hours                      ....................  ....................  ....................  .................          2,293,004
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\1\There are no capital costs or operating and maintenance costs associated with this collection of information.


                                                   Table 4.--Estimated Annual Recordkeeping Burden\1\
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                                                                        No. of Responses per
                 21 CFR Section                   No. of Recordkeepers      Recordkeeper      Total Annual Records   Hours per Record     Total Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
203.23(a) and (b)                                               31,676                     5               158,380                .25             39,595
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203.23(c)                                                       31,676                     5               158,380                .08             12,670
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203.30(a)(2) and 203.31(a)(2)                                    2,208                   100               220,800                .50            110,400
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[[Page 13602]]

 
203.31(d)(1) and (d)(2)                                          2,208                     1                 2,208              40.00             88,320
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203.31(d)(4)                                                       442                     1                   442              24.00             10,608
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203.31(e)                                                        2,208                     1                 2,208               1.00              2,208
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203.34                                                           2,208                     1                 2,208              40.00             88,320
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203.37(a)                                                           25                     1                    25              18.00                450
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203.37(b)                                                          200                     1                   200              18.00              3,600
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203.39(d)                                                           65                     1                    65               1.00                 65
--------------------------------------------------------------------------------------------------------------------------------------------------------
203.39(e)                                                        3,221                     1                 3,221                .50              1,610
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203.39(f)                                                        3,221                     1                 3,221               8.00             25,768
--------------------------------------------------------------------------------------------------------------------------------------------------------
203.39(g)                                                        3,221                     1                 3,221               8.00             25,768
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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 Recordkeeping Burden Hours                  ....................  ....................  ....................  .................            409,409
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\There are no capital costs or operating and maintenance costs associated with this collection of information.


    Dated: March 10, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6-3818 Filed 3-15-06; 8:45 am]
BILLING CODE 4160-01-S