Agency Information Collection Activities; Proposed Collection; Comment Request; Prescription Drug Marketing Act of 1987; Administrative Procedures, Policies, and Requirements

Federal Register, Volume 79 Issue 220 (Friday, November 14, 2014)

Federal Register Volume 79, Number 220 (Friday, November 14, 2014)

Notices

Pages 68273-68275

From the Federal Register Online via the Government Printing 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, PRAStaff@fda.hhs.gov.

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

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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

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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

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