2017-26933. 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.

SUMMARY:

The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (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 February 12, 2018.

ADDRESSES:

You may submit comments as follows. Please note that late, untimely filed comments will not be considered. Electronic comments must be submitted on or before February 12, 2018. The https://www.regulations.gov electronic filing system will accept comments until midnight Eastern Time at the end of February 12, 2018. Comments received by mail/hand delivery/courier (for written/paper submissions) will be considered timely if they are postmarked or the delivery service acceptance receipt is on or before that date.

Electronic Submissions

Submit electronic comments in the following way:

• Federal eRulemaking Portal: https://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to https://www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else's Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on https://www.regulations.gov.
• If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”).

Written/Paper Submissions

Submit written/paper submissions as follows:

• Mail/Hand delivery/Courier (for written/paper submissions): Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments submitted to the Dockets Management Staff, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.”

Instructions: All submissions received must include the Docket No. FDA-2011-N-0279 for “Agency Information Collection Activities; Proposed Collection; Comment Request; Prescription Drug Marketing Act of 1987; Administrative Procedures, Policies, and Requirements.” Received comments, those filed in a timely manner (see ADDRESSES), will be placed in the docket and, except for those submitted as “Confidential Submissions,” publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday.

• Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.” The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on https://www.regulations.gov. Submit both copies to the Dockets Management Staff. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as “confidential.” Any information marked as “confidential” will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA's posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: https://www.gpo.gov/​fdsys/​pkg/​FR-2015-09-18/​pdf/​2015-23389.pdf.

Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the “Search” box and follow the prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

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, [e-mail].

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

OMB Control Number 0910-0435—Extension

This information collection supports FDA regulations. Specifically, regulations codified at 21 CFR part 203 implement 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 tables below we have listed specific regulatory provisions that include information collection.

We estimate the burden of the information collection as follows:

Table 1—Estimated Annual Reporting Burden ¹

21 CFR section/activity	Number of respondents	Number of responses per respondent	Total annual responses	Average burden per response (in hours)	Total hours
203.11—Reimportation	1	1	1	0.5	1
203.30(a)(1) and (b)—Drug sample requests	61,961	12	743,532	0.06	44,612
203.30(a)(3), (a)(4), and (c)—Drug sample receipts	61,961	12	743,532	0.06	44,612
203.31(a)(1) and (b)—Drug sample requests	232,355	135	31,367,925	0.04	1,254,717
203.31(a)(3), (a)(4), and (c)—Drug sample receipts	232,355	135	31,367,925	0.03	941,038
203.37(a)—Falsification of records	50	4	200	0.25	50
203.37(b)—Loss or theft of samples	50	40	2,000	0.25	500
203.37(c)—Convictions	1	1	1	1	1
203.37(d)—Contact person	50	1	50	0.08	4
203.39(g)—Reconciliation report	1	1	1	1	1
Total					2,285,536
1 There are no capital costs or operating and maintenance costs associated with this collection of information.

Table 2—Estimated Annual Recordkeeping Burden ¹

21 CFR section/activity	Number of recordkeepers	Number of records per recordkeeper	Total annual records	Average burden per recordkeeping (in hours)	Total hours
203.23(a) and (b)—Returned drugs	31,676	5	158,380	0.25	39,595
203.23(c)—Returned drugs documentation	31,676	5	158,380	0.08	12,670
203.30(a)(2) and 203.31(a)(2)—Practitioner verification	2,208	100	220,800	0.5	110,400
203.31(d)(1) and (d)(2)—Inventory record and reconciliation report	2,208	1	2,208	40	88,320
203.31(d)(4)—Investigation of discrepancies and losses	442	1	442	24	10,608
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 records	50	4	200	6	1,200
203.37(b)—Loss or theft of drug samples	50	40	2,000	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	0.5	1,611
203.39(f)—Distribution of donated drug samples	3,221	1	3,221	8	25,768
203.39(g)—Drug samples donated to charitable institutions	3,221	1	3,221	8	25,768
203.50(a)—Drug origin statement	125	100	12,500	0.17	2,125
203.50(b)—Drug origin statement retention	125	100	12,500	0.5	6,250
203.50(d)—Authorized distributors of record	691	1	691	2	1,382
Total					343,570
1 There are no capital costs or operating and maintenance costs associated with this collection of information.

Based on a review of the information collection, we have retained the currently approved estimated burden.

Dated: December 8, 2017.

Leslie Kux,

Associate Commissioner for Policy.