Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Prescription Drug Marketing; Administrative Procedures, Policies, and Requirements
Federal Register, Volume 83 Issue 101 (Thursday, May 24, 2018)
Federal Register Volume 83, Number 101 (Thursday, May 24, 2018)
Notices
Pages 24127-24128
From the Federal Register Online via the Government Publishing Office www.gpo.gov
FR Doc No: 2018-11113
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Docket No. FDA-2011-N-0279
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Prescription Drug Marketing; 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 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 June 25, 2018.
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: 202-395-7285, or emailed 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: Domini Bean, Office of Operations, Food and Drug Administration, Three White Flint North, 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-5733, 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--Administrative Procedures, Policies, and Requirements
OMB Control Number 0910-0435--Extension
This information collection supports FDA regulations codified at part 203 (21 CFR part 203) implementing the Prescription Drug Marketing Act of 1987 (PDMA). The PDMA was intended to ensure safe and effective drug products and to avoid an unacceptable risk that counterfeit, adulterated, misbranded, subpotent, or expired drugs are sold to consumers. The reporting and recordkeeping requirements found in the regulations 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 healthcare 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, or the offer to sell, purchase, or trade, of prescription drugs that were purchased by hospitals or other healthcare entities or that were donated or supplied at a reduced price to a charitable organization; and (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 December 14, 2017 (82 FR 58808), we published a notice soliciting public comment of the information collection. One caller responded to the notice asking about the impact the Drug Supply Chain Security Act (DSCSA) (Title II of the Drug Quality Security Act of 2013) has on the information collection. We note that the Agency is currently proposing to amend its regulations at part 203 to reflect changes resulting from enactment of the DSCSA (RIN 0910-AH56). While we expect these changes will result in a reduction of burden associated with the information collection, current regulations and associated information collection requirements remain in effect. Upon finalization of rulemaking, we will revise the information collection accordingly.
We therefore estimate the burden for the information collection as follows:
Page 24128
Table 1--Estimated Annual Reporting Burden \1\
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Number of
21 CFR section/a ctivity Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
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203.11--Reimportation.......... 1 1 1 0.5 (30 1
minutes).
203.30(a)(1) and (b)--Drug 61,961 12 743,532 0.06 (4 44,612
sample requests. minutes).
203.30(a)(3), (a)(4), and (c)-- 61,961 12 743,532 0.06 (4 44,612
Drug sample receipts. minutes).
203.31(a)(1) and (b)--Drug 232,355 135 31,367,925 0.04 (2.5 1,254,717
sample requests. minutes).
203.31(a)(3), (a)(4), and (c)-- 232,355 135 31,367,925 0.03 (2 941,038
Drug sample receipts. minutes).
203.37(a)--Falsification of 50 4 200 0.25 (15 50
records. minutes).
203.37(b)--Loss or theft of 50 40 2,000 0.25 (15 500
samples. minutes).
203.37(c)--Convictions......... 1 1 1 1.............. 1
203.37(d)--Contact person...... 50 1 50 0.08 (5 4
minutes).
203.39(g)--Reconciliation 1 1 1 1.............. 1
report.
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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 Average burden
21 CFR Section/Activity Number of records per Total annual per Total hours
recordkeepers recordkeeper records recordkeeping
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203.23(a) and (b)--Returned 31,676 5 158,380 0.25 (15 39,595
drugs. minutes).
203.23(c)--Returned drugs 31,676 5 158,380 0.08 (5 12,670
documentation. minutes).
203.30(a)(2) and 203.31(a)(2)-- 2,208 100 220,800 0.5 (30 110,400
Practitioner verification. minutes).
203.31(d)(1) and (2)--Inventory 2,208 1 2,208 40............. 88,320
record and reconciliation
report.
203.31(d)(4)--Investigation of 442 1 442 24............. 10,608
discrepancies and losses.
203.31(e)--Representatives 2,208 1 2,208 1.............. 2,208
lists.
203.34--Administrative systems. 90 1 90 40............. 3,600
203.37(a)--Falsification of 50 4 200 6.............. 1,200
drug sample records.
203.37(b)--Loss or theft of 50 40 2,000 6.............. 12,000
drug samples.
203.39(d)--Destroyed or 65 1 65 1.............. 65
returned drug samples.
203.39(e)--Donated drug samples 3,221 1 3,221 0.5 (30 1,611
minutes).
203.39(f)--Distribution of 3,221 1 3,221 8.............. 25,768
donated drug samples.
203.39(g)--Drug samples donated 3,221 1 3,221 8.............. 25,768
to charitable institutions.
203.50(a)--Drug origin 125 100 12,500 0.17 (10 2,125
statement. minutes).
203.50(b)--Drug origin 125 100 12,500 0.5 (30 6,250
statement retention. minutes).
203.50(d)--Authorized 691 1 691 2.............. 1,382
distributors of record.
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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.
Based on a review of Agency data, we retain the currently approved burden estimate for the information collection, as reflected in tables 1 and 2 above.
Dated: May 18, 2018.
Leslie Kux,
Associate Commissioner for Policy.
FR Doc. 2018-11113 Filed 5-23-18; 8:45 am
BILLING CODE 4164-01-P
