2017-16607. Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Prescription Drug Advertisements

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

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 September 6, 2017.

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: [phone], or emailed to [e-mail]. All comments should be identified with the OMB control number 0910-0686. 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, 10A63, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-5733, [e-mail].

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 Advertisements (OMB Control Number 0910-0686—Extension)

This information collection supports Agency regulations. Section 502(n) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 352(n)) requires that manufacturers, packers, and distributors (sponsors) who advertise prescription human and animal drugs, including biological products for humans, disclose in advertisements certain information about the advertised product's uses and risks. For prescription drugs and biologics, section 502(n) of the FD&C Act requires advertisements to contain “a true statement . . .” of certain information including “. . . information in brief summary relating to side effects, contraindications, and effectiveness . . .” as required by regulations issued by FDA.

FDA's prescription drug advertising regulations at § 202.1 (21 CFR 202.1) describe requirements and standards for print and broadcast advertisements. Section 202.1 applies to advertisements published in journals, magazines, other periodicals, and newspapers, and advertisements broadcast through media such as radio, television, and telephone communication systems. Print advertisements must include a brief summary of each of the risk concepts from the product's approved package labeling (§ 202.1(e)(1)). Advertisements that are broadcast through media such as television, radio, or telephone communications systems must disclose the major risks from the product's package labeling in either the audio or audio and visual parts of the presentation (§ 202.1(e)(1)); this disclosure is known as the “major statement.” If a broadcast advertisement omits the major statement, or if the major statement minimizes the risks associated with the use of the drug, the advertisement could render the drug misbranded in violation of section 502(n) of the FD&C Act, section 201(n) of the FD&C Act (21 U.S.C. 321(n)), and FDA's implementing regulations at § 202.1(e).

Advertisements subject to the requirements at § 202.1 are subject to the PRA because these advertisements disclose information to the public. In addition, § 202.1(e)(6) and (j) include provisions that are subject to OMB approval under the PRA.

Reporting to FDA

Section 202.1(e)(6) permits a person who would be adversely affected by the enforcement of a provision of § 202.1(e)(6) to request a waiver from FDA for that provision. The waiver request must set forth clearly and concisely the petitioner's interest in the advertisement, the specific provision of § 202.1(e)(6) from which a waiver is sought, a complete copy of the advertisement, and a showing that the advertisement is not false, lacking in fair balance, misleading, or otherwise violative of section 502(n) of the FD&C Act.

Section 202.1(j), which sets forth requirements for the dissemination of advertisements subject to the standards in § 202.1(e), contains the following information collection that is subject to the PRA:

Under § 202.1(j)(1), a sponsor must submit advertisements to FDA for prior approval before dissemination if: (1) The sponsor or FDA has received information that has not been widely publicized in medical literature that the use of the drug may cause fatalities or serious damage; (2) FDA has notified the sponsor that the information must be part of the advertisements for the drug; and (3) the sponsor has failed to present to FDA a program for assuring that such information will be publicized promptly and adequately to the medical profession in subsequent advertisements, or if such a program has been presented to FDA but is not being followed by the sponsor.

Under § 202.1(j)(1)(iii), a sponsor must provide to FDA a program for assuring that significant new adverse information about the drug that becomes known (i.e., use of drug may cause fatalities or serious damage) will be publicized promptly and adequately to the medical profession in any subsequent advertisements.

Under § 202.1(j)(4), a sponsor may voluntarily submit advertisements to FDA for comment prior to publication.

Disclosures to the Public

Under § 202.1, advertisements for human and animal prescription drug and biological products must comply with the standards described in that section.

Under § 202.1(j)(1), if information that the use of a prescription drug may cause fatalities or serious damage has not been widely publicized in the medical literature, a sponsor must include such information in the advertisements for that drug.

In the Federal Register of May 23, 2017 (82 FR 23574), we published a 60-day notice requesting public comment on the proposed extension of this collection of information. One comment was received but did not respond to the information collection topics solicited in the notice and therefore we do not discuss it here.

FDA estimates the burden of this collection of information as follows:

Table 1—Estimated Annual Reporting Burden ¹

21 CFR section or activity	Number of respondents	Number of responses per respondent	Total annual responses	Hours per response	Total hours
CDER
202.1(e)(6); waiver request	1	1	1	12	12
202.1(j)(1); submission of advertisement	1	1	1	2	2
202.1(j)(1)(iii); assuring that adverse information be publicized	1	1	1	12	12
202.1(j)(4); voluntary submission of ad to FDA	71	6.97	495	20	9,900
CBER
202.1(e)(6); waiver request	0	0	0	12	0
202.1(j)(1); submission of advertisement	0	0	0	2	0
202.1(j)(1)(iii); assuring that adverse information be publicized	0	0	0	12	0
202.1(j)(4); voluntary submission of ad to FDA	9	8	72	20	1,440
CVM
202.1(e)(6); waiver request	0	0	0	12	0
202.1(j)(1); submission of advertisement	0	0	0	2	0
202.1(j)(1)(iii); assuring that adverse information be publicized	0	0	0	12	0
202.1(j)(4); voluntary submission of ad to FDA	5	1	5	20	100
Total					11,466
1 There are no capital costs or operating and maintenance costs associated with this collection.

Table 2—Estimated Annual Third-Party Disclosure Burden ¹

21 CFR section or activity	Number of respondents	Number of disclosures per respondent	Total annual disclosures	Average burden per disclosure	Total hours
CDER
202.1; ad prepared in accordance with part 202	394	105.3	41,494	400	16,597,600
202.1(j)(1); info. included re. fatalities or serious damage	1	1	1	40	40
CBER
202.1; ad prepared in accordance with part 202	47	63.4	2,984	400	1,193,600
202.1(j)(1); info. included re. fatalities or serious damage	0	0	0	40	0
CVM
202.1; ad prepared in accordance with part 202	25	36	900	400	360,000
202.1(j)(1); info. included re. fatalities or serious damage	0	0	0	40	0
Total					18,151,240
1 There are no capital costs or operating and maintenance costs associated with this collection.

Dated: August 2, 2017.

Anna K. Abram,

Deputy Commissioner for Policy, Planning, Legislation, and Analysis.