[Federal Register Volume 79, Number 220 (Friday, November 14, 2014)]
[Notices]
[Pages 68273-68275]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-26917]
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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.
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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 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 January 13, 2015.
ADDRESSES: Submit electronic comments on the collection of information
to: http://www.regulations.gov. 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: FDA PRA Staff, Office of Operations,
Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver
Spring, MD 20993-0002, [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--21 CFR Part 203--(OMB Control Number 0910-
0435)--Extension
FDA is requesting OMB approval under the PRA (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). 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
[[Page 68274]]
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 existing reporting
and recordkeeping requirements:
Table 1--Reporting Requirements
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21 CFR section Requirement
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203.11............................ Applications for re-importation 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.
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Table 2--Recordkeeping Requirements
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21 CFR section Requirement
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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 by the
appropriate State authority 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.
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.
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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 1--Estimated Annual Reporting Burden 1
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Number of
21 CFR section Number of responses per Total annual Average burden per response Total hours
respondents respondent respondents
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203.11 Re-importation....................... 1 1 1 .50 (30 minutes).......................... 1
203.30(a)(1) and (b) Drug sample requests... 61,961 12 743,532 .06 (4 minutes)........................... 44,612
[[Page 68275]]
203.30(a)(3), (a)(4), (c) Drug sample 61,961 12 743,532 .06 (4 minutes)........................... 44,612
receipts.
203.31(a)(1) and (b) Drug sample requests... 232,355 135 31,367,925 .04 (2 minutes)........................... 1,254,717
203.31(a)(3), (a)(4),(c) Drug sample 232,355 135 31,367,925 .03 (2 minutes)........................... 941,038
receipts.
203.37(a) Falsification of records.......... 50 4 200 .25 (15 minutes).......................... 50
203.37(b) Loss or theft of samples.......... 50 40 2000 .25 (15 minutes).......................... 500
203.37(c) Convictions....................... 1 1 1 1......................................... 1
203.37(d) Contact person.................... 50 1 50 .08 (5 minutes)........................... 4
203.39(g) Reconciliation report............. 1 1 1 1......................................... 1
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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
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Number of
21 CFR section Number of records per Total annual Average burden per record-keeping Total hours
recordkeepers recordkeeper records
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203.23(a) and (b) Returned drugs............ 31,676 5 158,380 .25 (15 minutes).......................... 39,595
203.23(c) Returned drugs documentation...... 31,676 5 158,380 .08 (5 minutes)........................... 12,670
203.30(a)(2) and 203.31(a)(2) Practitioner 2,208 100 220,800 .50 (30 minutes).......................... 110,400
verification.
203.31(d)(1) and (d)(2) Inventory record and 2,208 1 2,208 40........................................ 88,320
reconciliation report.
203.31(d)(4) Investigation of discrepancies 442 1 442 24........................................ 10,608
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 sample 50 4 200 6......................................... 1200
records.
203.37(b) Loss or theft of drug samples..... 50 40 2000 6......................................... 12,000
203.39(d) Destroyed or returned drug samples 65 1 65 1......................................... 65
203.39(e) Donated drug samples.............. 3,221 1 3,221 .50 (30 minutes).......................... 1,611
203.39(f) Distribution of donated drug 3,221 1 3,221 8......................................... 25,768
samples.
203.39(g) Drug samples donated to charitable 3,221 1 3,221 8......................................... 25,768
institutions.
203.50(a) Drug origin statement............. 125 100 12,500 .17 (10 minutes).......................... 2,125
203.50(b) Drug origin statement retention... 125 100 12,500 .50 (30 minutes).......................... 6,250
203.50(d) Authorized distributors of record. 691 1 691 2......................................... 1,382
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Total................................... .............. .............. .............. .......................................... 343,570
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: November 7, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-26917 Filed 11-13-14; 8:45 am]
BILLING CODE 4164-01-P