82 FR 23574 - Agency Information Collection Activities; Proposed Collection; Comment Request; Prescription Drug Advertisements

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 82, Issue 98 (May 23, 2017)

Page Range		23574-23576
FR Document		2017-10533

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 reporting requirements, including third party disclosure, contained in FDA's current regulations on prescription drug advertisements.

Federal Register, Volume 82 Issue 98 (Tuesday, May 23, 2017)

[Federal Register Volume 82, Number 98 (Tuesday, May 23, 2017)]
[Notices]
[Pages 23574-23576]
From the Federal Register Online [www.thefederalregister.org]
[FR Doc No: 2017-10533]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-N-0110]

Agency Information Collection Activities; Proposed Collection;
Comment Request; Prescription Drug Advertisements

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 reporting requirements, including third
party disclosure, contained in FDA's current regulations on
prescription drug advertisements.

DATES: Submit either electronic or written comments on the collection
of information by July 24, 2017.

ADDRESSES: You may submit comments as follows:

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): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For written/paper comments submitted to the Division of
Dockets Management, 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-2010-N-0110 for ``Prescription Drug Advertisements.'' Received
comments will be placed in the docket and, except for those submitted
as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Division of Dockets Management 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 Division of Dockets Management. 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

[[Page 23575]]

information about FDA's posting of comments to public dockets, see 80
FR 56469, September 18, 2015, or access the information at: https://www.thefederalregister.org/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 Division of Dockets Management, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: JonnaLynn Capezzuto, Office of
Operations, Food and Drug Administration, Three White Flint North,
10A63, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-3794.

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 Advertisements; OMB Control Number 0910-0686--
Extension

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 Sec. 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 (Sec. 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 (Sec. 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 Sec. 202.1(e).
Advertisements subject to the requirements at Sec. 202.1 are
subject to the PRA because these advertisements disclose information to
the public. In addition, Sec. 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 Sec. 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 Sec. 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 Sec.
202.1(e), contains the following information collection that is subject
to the PRA:
Under Sec. 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 Sec. 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 Sec. 202.1(j)(4), a sponsor may voluntarily submit
advertisements to FDA for comment prior to publication.

Disclosures to the Public

Under Sec. 202.1, advertisements for human and animal prescription
drug and biological products must comply with the standards described
in that section.
Under Sec. 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.
We estimate the burden of this collection of information as
follows:

[[Page 23576]]

Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
21 CFR section or activity Number of responses per Total annual Hours per Total hours
respondents respondent responses response
--------------------------------------------------------------------------------------------------------------------------------------------------------
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 1 1 1 12 12
publicized...................................................
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 0 0 0 12 0
publicized...................................................
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 0 0 0 12 0
publicized...................................................
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\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
21 CFR section or activity Number of responses per Total annual Hours per Total hours
respondents respondent responses response
--------------------------------------------------------------------------------------------------------------------------------------------------------
CDER:
202.1; ad prepared in accordance with 21 CFR 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 21 CFR 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 21 CFR 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: May 18, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-10533 Filed 5-22-17; 8:45 am]
BILLING CODE 4164-01-P

23576 Federal Register / Vol. 82, No. 98 / Tuesday, May 23, 2017 / Notices

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
Number of Total annual Hours per
21 CFR section or activity responses per Total hours
respondents responses response
respondent

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 informa-
tion 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 informa-
tion 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 informa-
tion 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
Number of
Number of Total annual Hours per
21 CFR section or activity responses per Total hours
respondents responses response
respondent

CDER:
202.1; ad prepared in accordance with 21
CFR Part 202 ................................................ 394 105.3 41,494 400 16,597,600
202.1(j)(1); info. included re. fatalities or seri-
ous damage .................................................. 1 1 1 40 40
CBER:
202.1; ad prepared in accordance with 21
CFR Part 202 ................................................ 47 63.4 2,984 400 1,193,600
202.1(j)(1); info. included re. fatalities or seri-
ous damage .................................................. 0 0 0 40 0
CVM:
202.1; ad prepared in accordance with 21
CFR Part 202 ................................................ 25 36 900 400 360,000
202.1(j)(1); info. included re. fatalities or seri-
ous 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: May 18, 2017. DEPARTMENT OF HEALTH AND certain information by the Agency.
Anna K. Abram, HUMAN SERVICES Under the Paperwork Reduction Act of
Deputy Commissioner for Policy, Planning, 1995 (the PRA), Federal Agencies are
Legislation, and Analysis. Food and Drug Administration required to publish notice in the
[FR Doc. 2017–10533 Filed 5–22–17; 8:45 am] [Docket No. FDA–2017–N–1848] Federal Register concerning each
proposed collection of information,
BILLING CODE 4164–01–P
Agency Information Collection including each proposed extension of an
Activities; Proposed Collection; existing collection of information, and
Comment Request; Cosmetic Labeling to allow 60 days for public comment in
Regulations response to the notice. This notice
solicits comments on information
sradovich on DSK3GMQ082PROD with NOTICES

AGENCY: Food and Drug Administration, collection provisions in FDA’s cosmetic
HHS. labeling regulations.
ACTION: Notice. DATES: Submit either electronic or
SUMMARY: The Food and Drug written comments on the collection of
Administration (FDA or we) is information by July 24, 2017.
announcing an opportunity for public ADDRESSES: You may submit comments
comment on the proposed collection of as follows:

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Document Created: 2017-05-23 02:14:48
Document Modified: 2017-05-23 02:14:48

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Action		Notice.
Dates		Submit either electronic or written comments on the collection of information by July 24, 2017.
Contact		JonnaLynn Capezzuto, Office of Operations, Food and Drug Administration, Three White Flint North, 10A63, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-3794.
FR Citation		82 FR 23574

82 FR 23574 - Agency Information Collection Activities; Proposed Collection; Comment Request; Prescription Drug Advertisements

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 82, Issue 98 (May 23, 2017)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration