82 FR 36799 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Prescription Drug Advertisements
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 82, Issue 150 (August 7, 2017)
Food and Drug Administration
Federal Register Volume 82, Issue 150 (August 7, 2017)
| Page Range | 36799-36801 | |
| FR Document | 2017-16607 |
[Federal Register Volume 82, Number 150 (Monday, August 7, 2017)] [Notices] [Pages 36799-36801] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-16607] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0110] 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: 202-395-7285, or emailed to [email protected]. 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, [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 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 [[Page 36800]] 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. 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\ ---------------------------------------------------------------------------------------------------------------- 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 1 1 1 2 2 advertisement.................. 202.1(j)(1)(iii); assuring that 1 1 1 12 12 adverse information be publicized..................... 202.1(j)(4); voluntary 71 6.97 495 20 9,900 submission of ad to FDA........ ---------------------------------------------------------------------------------------------------------------- CBER ---------------------------------------------------------------------------------------------------------------- 202.1(e)(6); waiver request..... 0 0 0 12 0 202.1(j)(1); submission of 0 0 0 2 0 advertisement.................. 202.1(j)(1)(iii); assuring that 0 0 0 12 0 adverse information be publicized..................... 202.1(j)(4); voluntary 9 8 72 20 1,440 submission of ad to FDA........ ---------------------------------------------------------------------------------------------------------------- CVM ---------------------------------------------------------------------------------------------------------------- 202.1(e)(6); waiver request..... 0 0 0 12 0 202.1(j)(1); submission of 0 0 0 2 0 advertisement.................. [[Page 36801]] 202.1(j)(1)(iii); assuring that 0 0 0 12 0 adverse information be publicized..................... 202.1(j)(4); voluntary 5 1 5 20 100 submission of ad to FDA........ ------------------------------------------------------------------------------- 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 disclosures Total annual Average 21 CFR section or activity respondents per disclosures burden per Total hours respondent disclosure ---------------------------------------------------------------------------------------------------------------- CDER ---------------------------------------------------------------------------------------------------------------- 202.1; ad prepared in accordance 394 105.3 41,494 400 16,597,600 with part 202.................. 202.1(j)(1); info. included re. 1 1 1 40 40 fatalities or serious damage... ---------------------------------------------------------------------------------------------------------------- CBER ---------------------------------------------------------------------------------------------------------------- 202.1; ad prepared in accordance 47 63.4 2,984 400 1,193,600 with part 202.................. 202.1(j)(1); info. included re. 0 0 0 40 0 fatalities or serious damage... ---------------------------------------------------------------------------------------------------------------- CVM ---------------------------------------------------------------------------------------------------------------- 202.1; ad prepared in accordance 25 36 900 400 360,000 with part 202.................. 202.1(j)(1); info. included re. 0 0 0 40 0 fatalities or serious damage... ------------------------------------------------------------------------------- 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. [FR Doc. 2017-16607 Filed 8-4-17; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 82, No. 150 / Monday, August 7, 2017 / Notices 36799
2. Notification of Results of Tests and primary responsibility for providing Dated: August 2, 2017.
Investigations Regarding or Possibly data demonstrating the safety, purity, Anna K. Abram,
Impacting the Product and potency of the final product. We Deputy Commissioner for Policy, Planning,
In the guidance, we recommend the also state that we expect the licensed Legislation, and Analysis.
following for contract manufacturing finished product manufacturer to be [FR Doc. 2017–16564 Filed 8–4–17; 8:45 am]
primarily responsible for any
arrangements: BILLING CODE 4164–01–P
postapproval obligations, such as
• The contract manufacturer should
postmarketing clinical trials, additional
fully inform the license manufacturer of
product stability studies, complaint DEPARTMENT OF HEALTH AND
the results of all tests and investigations
handling, recalls, postmarket reporting HUMAN SERVICES
regarding or possibly having an impact
of the dissemination of advertising and
on the product; and Food and Drug Administration
promotional labeling materials as
• The license manufacturer should
required under § 601.12(f)(4), and [Docket No. FDA–2010–N–0110]
obtain assurance from the contractor
adverse experience reporting. We
that any FDA list of inspectional
recommend that the final product Agency Information Collection
observations will be shared with the manufacturer establish a procedure with
license manufacturer to allow Activities; Submission for Office of
the other participating manufacturer(s) Management and Budget Review;
evaluation of its impact on the purity, to obtain information in these areas.
potency, and safety of the license Comment Request; Prescription Drug
Description of Respondents: Advertisements
manufacturer’s product. Respondents to the information
3. Notification of Products collection are participating licensed AGENCY: Food and Drug Administration,
Manufactured in a Contract Facility manufacturers, final product HHS.
manufacturers, and contract ACTION: Notice.
In the guidance, we recommend for manufacturers associated with
contract manufacturing arrangements cooperative manufacturing SUMMARY: The Food and Drug
that a license manufacturer cross arrangements subject to the associated Administration (FDA) is announcing
reference a contract manufacturing regulations discussed in the guidance. that a proposed collection of
facility’s master files only in Burden Estimate: We believe that the information has been submitted to the
circumstances involving certain information collection provisions in the Office of Management and Budget
proprietary information of the contract guidance do not create a new burden for (OMB) for review and clearance under
manufacturer, such as a list of all respondents. We believe the reporting the Paperwork Reduction Act of 1995.
products manufactured in a contract and recordkeeping provisions are part of DATES: Fax written comments on the
facility. In this situation, the license usual and customary business practices. collection of information by September
manufacturer should be kept informed Licensed manufacturers would have 6, 2017.
of the types or categories of all products contractual agreements with ADDRESSES: To ensure that comments on
manufactured in the contract facility. participating licensed manufacturers, the information collection are received,
4. Standard Operating Procedures final product manufacturers, and OMB recommends that written
contract manufacturers, as applicable comments be faxed to the Office of
In the guidance, we remind the for the type of cooperative Information and Regulatory Affairs,
license manufacturer that the license manufacturing arrangement, to address OMB, Attn: FDA Desk Officer, FAX:
manufacturer assumes responsibility for all these information collection 202–395–7285, or emailed to oira_
compliance with the applicable product provisions. submission@omb.eop.gov. All
and establishment standards (21 CFR The guidance also refers to previously comments should be identified with the
600.3(t)). Therefore, if the license approved collections of information OMB control number 0910–0686. Also
manufacturer enters into an agreement found in FDA regulations at parts 201, include the FDA docket number found
with a contract manufacturing facility, 207, 211, 600, 601, 606, 607, 610, 660, in brackets in the heading of this
the license manufacturer must ensure 801, 803, 807, 809, and 820 (21 CFR document.
that the facility complies with the parts 201, 207, 211, 600, 601, 606, 607,
applicable standards. An agreement 610, 660, 801, 803, 807, 809, and 820). FOR FURTHER INFORMATION CONTACT:
between a license manufacturer and a The collections of information in parts Domini Bean, Office of Operations,
contract manufacturing facility normally 606 and 610 have been approved under Food and Drug Administration, Three
includes procedures to regularly assess OMB control numbers 0910–0116, White Flint North, 10A63, 11601
the contract manufacturing facility’s 0910–0458, and 0910–0206; part 600 Landsdown St., North Bethesda, MD
compliance. These procedures may has been approved under OMB control 20852, 301–796–5733, PRAStaff@
include, but are not limited to, review numbers 0910–0308 and 0910–0458; fda.hhs.gov.
of records and manufacturing deviations parts 601 and 660 have been approved SUPPLEMENTARY INFORMATION: In
and defects, and periodic audits. under OMB control number 0910–0338; compliance with 44 U.S.C. 3507, FDA
For shared manufacturing part 803 has been approved under OMB has submitted the following proposed
arrangements, each manufacturer must control number 0910–0437; part 211 has collection of information to OMB for
submit a separate biologics license been approved under OMB control review and clearance.
application describing the number 0910–0139; part 820 has been
manufacturing facilities and operations approved under OMB control number Prescription Drug Advertisements (OMB
mstockstill on DSK30JT082PROD with NOTICES
applicable to the preparation of that 0910–0073; parts 207, 607, and 807 have Control Number 0910–0686—Extension)
manufacturer’s biological substance or been approved under OMB control This information collection supports
product (§ 601.2(a)). In the guidance, we numbers 0910–0045, 0910–0052, and Agency regulations. Section 502(n) of
state that we expect the manufacturer 0910–0625; and parts 201, 801, and 809 the Federal Food, Drug, and Cosmetic
that prepares, or is responsible for the have been approved under OMB control Act (the FD&C Act) (21 U.S.C. 352(n))
preparation of, the product in final form numbers 0910–0537, 0910–0572, and requires that manufacturers, packers,
for commercial distribution to assume 0910–0485. and distributors (sponsors) who
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![Federal Register / Vol. 82, No. 150 / Monday, August 7, 2017 / Notices 36801
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1—Continued
Number of
Number of responses Total annual Hours per Total
21 CFR section or activity respondents per responses response hours
respondent
202.1(j)(1)(iii); assuring that adverse information be pub-
licized ................................................................................ 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 Average
Number of disclosures Total annual Total
21 CFR section or activity burden per
respondents per disclosures hours
disclosure
respondent
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. review and approval. Comments Abstract: HRSA’s AIDS Drug
Anna K. Abram, submitted during the first public review Assistance Program (ADAP) is funded
Deputy Commissioner for Policy, Planning, of this ICR will be provided to OMB. through the Ryan White HIV/AIDS
Legislation, and Analysis. OMB will accept further comments from Program (RWHAP), Part B, Title XXVI of
[FR Doc. 2017–16607 Filed 8–4–17; 8:45 am] the public during the review and the Public Health Service Act, which
BILLING CODE 4164–01–P approval period. provides grants to states and territories.
DATES: Comments on this ICR should be The ADAP provides medications for the
received no later than September 6, treatment of HIV. Program funds may
DEPARTMENT OF HEALTH AND 2017. also be used to purchase health
HUMAN SERVICES ADDRESSES: Submit your comments, insurance for eligible clients and for
including the ICR Title, to the desk services that enhance access, adherence,
Health Resources and Services and monitoring of HIV drug treatments.
Administration officer for HRSA, either by email to
OIRA_submission@omb.eop.gov or by The following states, territories, and
Agency Information Collection fax to 202–395–5806. Pacific Island jurisdictions are eligible
Activities: Submission to OMB for FOR FURTHER INFORMATION CONTACT: To to apply for RWHAP ADAP funding: All
Review and Approval; Public Comment request a copy of the clearance requests 50 states, the District of Columbia, the
Request; Information Collection submitted to OMB for review, email the Commonwealth of Puerto Rico, the U.S.
Request Title: AIDS Drug Assistance HRSA Information Collection Clearance Virgin Islands, Guam, American Samoa,
Program Data Report, OMB No. 0915– Officer at paperwork@hrsa.gov or call the Commonwealth of the Northern
0345—Extension (301) 443–1984. Mariana Islands, the Republic of Palau,
SUPPLEMENTARY INFORMATION: When the Federated States of Micronesia, and
AGENCY: Health Resources and Services submitting comments or requesting the Republic of the Marshall Islands. As
Administration (HRSA), Department of information, please include the part of the funding requirements, ADAP
Health and Human Services (HHS). information request collection title for grant recipients submit reports
mstockstill on DSK30JT082PROD with NOTICES
ACTION: Notice reference, in compliance with Section concerning information on patients
3506(c)(2)(A) of the Paperwork served, eligibility requirements,
SUMMARY: In compliance with the Reduction Act of 1995. pharmaceuticals prescribed, pricing and
Paperwork Reduction Act of 1995, Information Collection Request Title: other sources of support to provide HIV
HRSA has submitted an Information AIDS Drug Assistance Program Data medication treatment, cost data, and
Collection Request (ICR) to the Office of Report OMB No. 0915–0345— coordination with Medicaid. The ADAP
Management and Budget (OMB) for Extension. Data Report (ADR) will be submitted
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Document Created: 2017-08-05 03:00:13
Document Modified: 2017-08-05 03:00:13
| 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 | Fax written comments on the collection of information by September 6, 2017. | |
| 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, [email protected] | |
| FR Citation | 82 FR 36799 |
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