[Federal Register Volume 74, Number 168 (Tuesday, September 1, 2009)]
[Notices]
[Pages 45216-45219]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-21026]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-N-0131]


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; 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 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 October 
1, 2009.

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: 202-395-6974, or e-mailed 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:  Elizabeth Berbakos, Office of 
Information Management (HFA-710), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-796-3792, 
[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; 21 CFR Part 203 (OMB Control 
Number 0910-0435)--Extension

    FDA is requesting OMB approval under the Paperwork Reduction Act 
(44 U.S.C. 3501-3520) 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 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:

[[Page 45217]]



                                        Table 1.--Reporting Requirements
21 CFR 203.11                                Applications for reimportation to provide emergency medical care.
----------------------------------------------------------------------------------------------------------------
21 CFR 203.30(a)(1) and (b)                  Drug sample requests (drug samples distributed by mail or common
                                              carrier).
----------------------------------------------------------------------------------------------------------------
21 CFR 203.30(a)(3), (a)(4), and (c)         Drug sample receipts (receipts for drug samples distributed by mail
                                              or common carrier).
----------------------------------------------------------------------------------------------------------------
21 CFR 203.31(a)(1) and (b)                  Drug sample requests (drug samples distributed by means other than
                                              the mail or a common carrier).
----------------------------------------------------------------------------------------------------------------
21 CFR 203.31(a)(3), (a)(4), and (c)         Drug sample receipts (drug samples distributed by means other than
                                              the mail or a common carrier).
----------------------------------------------------------------------------------------------------------------
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.
----------------------------------------------------------------------------------------------------------------


                                      Table 2.--Recordkeeping Requirements
21 CFR 203.23(a) and (b)                     Credit memo for returned drugs.
----------------------------------------------------------------------------------------------------------------
21 CFR 203.23(c)                             Documentation of proper storage, handling, and shipping conditions
                                              for returned drugs.
----------------------------------------------------------------------------------------------------------------
21 CFR 203.30(a)(2) and 21 CFR 203.31(a)(2)  Verification that a practitioner requesting a drug sample is
                                              licensed or authorized by the appropriate State authority to
                                              prescribe the product.
----------------------------------------------------------------------------------------------------------------
21 CFR 203.31(d)(1) and (d)(2)               Contents of the inventory record and 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 
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;

[[Page 45218]]

    (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.
    In the Federal Register of March 24, 2009 (74 FR 12365), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. We received one comment.
    Comment Summary: The comment pertained to the recordkeeping 
requirements in Sec.  203.50(a) and (b) (21 CFR 203.50(a) and (b)).
    The comment concluded that FDA's estimate of ``0'' recordkeeping 
hours for these regulations in table 2 of the March 24, 2009, notice 
was in error. In summary, the comment contended: (1) Pedigrees must be 
passed by nonauthorized distributors of record prior to each wholesale 
distribution; (2) all wholesale distributors that provide or receive 
pedigrees after December 1, 2006, must retain copies of the pedigrees 
for 3 years; and (3) those records must include names and addresses of 
all parties to the transaction and the date of the transactions.
    The comment offered no estimates for the recordkeeping provisions 
in Sec.  203.50(a) and (b). The comment explained that it is unable to 
suggest estimates for the burden hours because most of its members 
``have likely received a designation of `ADR' status by most drug 
manufacturers for most of the prescription drug products that they 
purchase, and they provide pedigrees only on a limited basis.'' Thus, 
the comment said, there are a large number of distributors that are not 
members of its organization but are subject to the pedigree 
requirements and, therefore, the burden hours that its members alone 
accrue would not be reflective of the entire population of distributors 
that are affected, and would likely be a minority of the total burden 
hours that all distributors experience.
    The comment recommended that FDA ``conduct a PRA review and 
estimate of the paperwork burden for healthcare distributors to comply 
with these regulations.''
    FDA Response: FDA appreciates the comment and, as requested, we 
plan to conduct research to obtain estimates for the burden hours that 
may be currently incurred by distributors to comply with the 
recordkeeping provisions in Sec.  203.50. We are requesting that 
interested persons submit to the docket (identified in brackets in the 
heading of this document) data on the burden hours currently incurred 
by distributors to comply with the recordkeeping provisions in Sec.  
203.50. In response to the comment, we are also adding to the Estimated 
Annual Recordkeeping Burden (table 4 of this document) recordkeeping 
estimates for Sec.  203.50. We used these estimates in previous Federal 
Register notices based on information we received at that time, and no 
comments were received on these burden hours. If our research results 
in new data that differs from these estimates, we will amend the 
approval for OMB control number 0910-0435 to include revised estimates 
for these provisions.
    FDA estimates the burden of this collection of information as 
follows:

                                 Table 3.--Estimated Annual Reporting Burden\1\
----------------------------------------------------------------------------------------------------------------
                      No. of         Annual Frequency       Total Annual        Hours per
21 CFR Section     Respondents         per Response          Responses           Response        Total Hours\2\
----------------------------------------------------------------------------------------------------------------
203.11                          1                     1                  1                .5                1
----------------------------------------------------------------------------------------------------------------
203.30(a)(1)               61,961                    12            743,532                .06          44,612
 and (b)
----------------------------------------------------------------------------------------------------------------
203.30(a)(3),              61,961                    12            743,532                .06          44,612
 (a)(4), and
 (c)
----------------------------------------------------------------------------------------------------------------
203.31(a)(1)              232,355                   135         31,367,925                .04       1,254,717
 and (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
----------------------------------------------------------------------------------------------------------------
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 Reporting Burden Hours                                                                        2,285,536
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.
\2\ Estimates are not exact due to rounding.


                               Table 4.--Estimated Annual Recordkeeping Burden\1\
----------------------------------------------------------------------------------------------------------------
                      No. of         Annual Frequency       Total Annual        Hours per
21 CFR Section     Respondents       per Recordkeeping       Responses           Response        Total Hours\2\
----------------------------------------------------------------------------------------------------------------
203.23(a) and              31,676                     5            158,380                .25             39,595
 (b)
----------------------------------------------------------------------------------------------------------------
203.23(c)                  31,676                     5            158,380                .08             12,670
----------------------------------------------------------------------------------------------------------------

[[Page 45219]]

 
203.30(a)(2)                2,208                   100            220,800                .50            110,400
 and
 203.31(a)(2)
----------------------------------------------------------------------------------------------------------------
203.31(d)(1)                2,208                     1              2,208              40                88,320
 and (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)                     125                   100             12,500                .17              2,125
----------------------------------------------------------------------------------------------------------------
203.50(b)                     125                   100             12,500                .50              6,250
----------------------------------------------------------------------------------------------------------------
203.50(d)                     691                     1                691               2.0               1,382
----------------------------------------------------------------------------------------------------------------
Total Recordkeeping Burden Hours                                                                         332,769
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.
\2\ Estimates are not exact due to rounding.


    Dated: August 25, 2009.
David Horowitz,
Assistant Commissioner for Policy.
[FR Doc. E9-21026 Filed 8-31-09; 8:45 am]
BILLING CODE 4160-01-S