Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Guidance for Industry on Postmarketing Adverse Event Reporting for Nonprescription Human Drug Products Marketed Without an Approved Application, 31024-31025 [2012-12589]

Download as PDF 31024 Federal Register / Vol. 77, No. 101 / Thursday, May 24, 2012 / Notices 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 oira_submission@omb.eop.gov. All comments should be identified with the OMB control number 0910–0636. Also include the FDA docket number found in brackets in the heading of this document. FOR FURTHER INFORMATION CONTACT: Juanmanuel Vilela, Office of Information Management, Food and Drug Administration, 1350 Piccard Dr., PI50–400B, Rockville, MD 20850, 301– 796–7651, juanmanuel.vilela@fda.hhs.gov. 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. The estimate of the burden is based on the number of IDEs received in the last 3 years. Dated: May 17, 2012. Leslie Kux, Assistant Commissioner for Policy. [FR Doc. 2012–12590 Filed 5–23–12; 8:45 am] BILLING CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2011–N–0915] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Guidance for Industry on Postmarketing Adverse Event Reporting for Nonprescription Human Drug Products Marketed Without an Approved Application AGENCY: Food and Drug Administration, HHS. ACTION: Notice. 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, 2012. ADDRESSES: To ensure that comments on the information collection are received, SUMMARY: Guidance for Industry on Postmarketing Adverse Event Reporting for Nonprescription Human Drug Products Marketed Without an Approved Application (OMB Control Number 0910–0636)— Extension. Respondents to this collection of information are manufacturers, packers, and distributors whose name (under section 502(b)(1) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act)) appears on the label of a nonprescription drug marketed in the United States. FDA is requesting public comment on estimates of annual submissions from these respondents, as required by Public Law 109–462 and described in the guidance. This guidance document discusses what should be included in a serious adverse drug event report submitted under section 760(b)(1) of the FD&C Act, including follow-up reports under 760(c)(2) of the FD&C Act, and how to submit these reports. The estimates for annual reporting burden and recordkeeping are based on FDA’s knowledge of adverse drug experience reports historically submitted per year for prescription drug products and for nonprescription drug products marketed under an approved application, including knowledge about the time needed to prepare the reports and to maintain records. FDA receives approximately 2,500 serious adverse event reports for nonprescription drug products marketed under approved applications, which comprise approximately 20 percent of the overall nonprescription drug market. Based on this experience, we estimate between 10,000 and 15,000 (i.e., 12,500) total annual responses for nonprescription drugs marketed without an approved application. In the Federal Register of December 27, 2011 (76 FR 80946), FDA published a 60-day notice requesting public comment on the proposed collection of information. FDA received no comments on the information collection. FDA estimates the burden of this collection of information as follows: TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1 Number of respondents Number of responses per respondent Average burden per response Total annual responses Total hours Reports of serious adverse drug events (21 U.S.C. 379aa((b) and (c)) ............................................................ 50 250 12,500 2 25,000 Total .............................................................................. ........................ ........................ ........................ ........................ 25,000 srobinson on DSK4SPTVN1PROD with NOTICES 1 There are no capital costs or operating and maintenance costs associated with this collection of information. Section 760(e) of the FD&C Act also requires that responsible persons maintain records of nonprescription adverse event reports, whether or not the event is serious, for a period of 6 years. The guidance recommends that responsible persons maintain records of efforts to obtain the minimum data elements for a report of a serious adverse drug event and any followup VerDate Mar<15>2010 16:31 May 23, 2012 Jkt 226001 reports. Although the guidance does not provide recommendations on recordkeeping activities generally under section 760(e) of the FD&C Act, FDA is providing an estimate for the burden of this collection. Historically, serious adverse event reports comprise approximately two-thirds and nonserious adverse event reports comprise approximately one-third of the PO 00000 Frm 00032 Fmt 4703 Sfmt 4703 total number of postmarketing adverse event reports associated with drugs and biologic therapeutics (except vaccines) received by FDA. Based on this generalization, FDA estimates the total annual records to be approximately 20,000 records per year. FDA estimates that it takes 5 hours to maintain each record and the recordkeeping burden as follows: E:\FR\FM\24MYN1.SGM 24MYN1 31025 Federal Register / Vol. 77, No. 101 / Thursday, May 24, 2012 / Notices TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1 Number of recordkeepers Number of records per recordkeeper Total annual records Average burden per recordkeeping Total hours Recordkeeping (21 U.S.C. 379aa(e)(1)) .............................. 200 100 20,000 5 100,000 Total .............................................................................. ........................ ........................ ........................ ........................ 100,000 1 There are no capital costs or operating and maintenance costs associated with this collection of information. Therefore, the estimated annual reporting burden for this information is 25,000 hours and the estimated annual recordkeeping burden is 100,000 hours. Dated: May 17, 2012. Leslie Kux, Assistant Commissioner for Policy. [FR Doc. 2012–12589 Filed 5–23–12; 8:45 am] BILLING CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2012–N–0001] Risk Communication Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. srobinson on DSK4SPTVN1PROD with NOTICES This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration (FDA). The meeting will be open to the public. Name of Committee: Risk Communication Advisory Committee. General Function of the Committee: To provide advice and recommendations to the Agency on FDA’s regulatory issues. Date and Time: The meeting will be held on June 29, 2012, from 8 a.m. to 3 p.m. Location: FDA White Oak Campus, Building 31 Conference Center, Great Room, 10903 New Hampshire Ave., Silver Spring, MD 20993. Information regarding special accommodations due to a disability, visitor parking, and transportation may be accessed at: https://www.fda.gov/AdvisoryCommittees/ default.htm; under the heading ‘‘Resources for You,’’ click on ‘‘Public Meetings at the FDA White Oak Campus.’’ Please note that visitors to the White Oak Campus must enter through Building 1. Contact Person: Lee L. Zwanziger, Risk Communication Staff, Office of Planning, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, rm. 3278, Silver Spring, MD 20993, 301–796–9151, FAX: 301– 847–8611, email: RCAC@fda.hhs.gov, or FDA Advisory Committee Information Line, 1– 800–741–8138 (301–443–0572 in the Washington, DC area), and follow the prompts to the desired center or product area. Please call the Information Line for upto-date information on this meeting. A notice VerDate Mar<15>2010 16:31 May 23, 2012 Jkt 226001 in the Federal Register about last minute modifications that impact a previously announced advisory committee meeting cannot always be published quickly enough to provide timely notice. Therefore, you should always check the Agency’s Web site and call the appropriate advisory committee hot line/phone line to learn about possible modifications before coming to the meeting. Agenda: On June 29, 2011, the Committee will discuss recent research on communicating and understanding uncertainty, and risk perception and information seeking when facing multiple risks. FDA intends to make background material available to the public no later than 2 business days before the meeting. If FDA is unable to post the background material on its Web site prior to the meeting, background material will be made publicly available at the location of the advisory committee meeting, and the background material will be posted on FDA’s Web site after the meeting. Background material is available at https:// www.fda.gov/AdvisoryCommittees/Calendar/ default.htm. Scroll down to the appropriate advisory committee link. Procedure: Interested persons may present data, information, or views, orally or in writing, on issues pending before the committee. Written submissions may be made to the contact person on or before June 21, 2012. Oral presentations from the public will be scheduled between approximately 1 p.m. and 2 p.m. on June 29, 2012. Those individuals interested in making formal oral presentations should notify the contact person and submit a brief statement of the general nature of the evidence or arguments they wish to present, the names and addresses of proposed participants, and an indication of the approximate time requested to make their presentation on or before June 18, 2012. Time allotted for each presentation may be limited. If the number of registrants requesting to speak is greater than can be reasonably accommodated during the scheduled open public hearing session, FDA may conduct a lottery to determine the speakers for the scheduled open public hearing session. The contact person will notify interested persons regarding their request to speak by June 19, 2012. Interested persons can also log on to https:// collaboration.fda.gov/rcac/ to hear and see the proceedings. Persons attending FDA’s advisory committee meetings are advised that the Agency is not responsible for providing access to electrical outlets. FDA welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate PO 00000 Frm 00033 Fmt 4703 Sfmt 4703 persons with physical disabilities or special needs. If you require special accommodations due to a disability, please contact Lee L. Zwanziger at least 7 days in advance of the meeting. FDA is committed to the orderly conduct of its advisory committee meetings. Please visit our Web site at https://www.fda.gov/ AdvisoryCommittees/ AboutAdvisoryCommittees/ucm111462.htm for procedures on public conduct during advisory committee meetings. Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app. 2). Dated: May 17, 2012. Leslie Kux, Assistant Commissioner for Policy. [FR Doc. 2012–12587 Filed 5–23–12; 8:45 am] BILLING CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2012–N–0001] Oncologic Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration (FDA). The meeting will be open to the public. Name of Committee: Oncologic Drugs Advisory Committee. General Function of the Committee: To provide advice and recommendations to the Agency on FDA’s regulatory issues. Date and Time: The meeting will be held on July 25, 2012, from 8 a.m. to 12:30 p.m. Location: FDA White Oak Campus, 10903 New Hampshire Ave., Building 31 Conference Center, the Great Room (Rm. 1503), Silver Spring, MD 20993–0002. Information regarding special accommodations due to a disability, visitor parking, and transportation may be accessed at: https://www.fda.gov/AdvisoryCommittees/ default.htm; under the heading ‘‘Resources for You,’’ click on ‘‘Public Meetings at the FDA White Oak Campus.’’ Please note that visitors to the White Oak Campus must enter through Building 1. E:\FR\FM\24MYN1.SGM 24MYN1

Agencies

[Federal Register Volume 77, Number 101 (Thursday, May 24, 2012)]
[Notices]
[Pages 31024-31025]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-12589]

-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0915]

Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Guidance for Industry
on Postmarketing Adverse Event Reporting for Nonprescription Human Drug
Products Marketed Without an Approved Application

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 June
25, 2012.

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 oira_submission@omb.eop.gov. All
comments should be identified with the OMB control number 0910-0636.
Also include the FDA docket number found in brackets in the heading of
this document.

FOR FURTHER INFORMATION CONTACT: Juanmanuel Vilela, Office of
Information Management, Food and Drug Administration, 1350 Piccard Dr.,
PI50-400B, Rockville, MD 20850, 301-796-7651,
juanmanuel.vilela@fda.hhs.gov.

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.

Guidance for Industry on Postmarketing Adverse Event Reporting for
Nonprescription

Human Drug Products Marketed Without an Approved Application (OMB
Control Number 0910-0636)--Extension.
Respondents to this collection of information are manufacturers,
packers, and distributors whose name (under section 502(b)(1) of the
Federal Food, Drug, and Cosmetic Act (the FD&C Act)) appears on the
label of a nonprescription drug marketed in the United States.
FDA is requesting public comment on estimates of annual submissions
from these respondents, as required by Public Law 109-462 and described
in the guidance. This guidance document discusses what should be
included in a serious adverse drug event report submitted under section
760(b)(1) of the FD&C Act, including follow-up reports under 760(c)(2)
of the FD&C Act, and how to submit these reports. The estimates for
annual reporting burden and recordkeeping are based on FDA's knowledge
of adverse drug experience reports historically submitted per year for
prescription drug products and for nonprescription drug products
marketed under an approved application, including knowledge about the
time needed to prepare the reports and to maintain records.
FDA receives approximately 2,500 serious adverse event reports for
nonprescription drug products marketed under approved applications,
which comprise approximately 20 percent of the overall nonprescription
drug market. Based on this experience, we estimate between 10,000 and
15,000 (i.e., 12,500) total annual responses for nonprescription drugs
marketed without an approved application.
In the Federal Register of December 27, 2011 (76 FR 80946), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. FDA received no comments on the information
collection.
FDA estimates the burden of this collection of information as
follows:

Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of Average
Number of responses per Total annual burden per Total hours
respondents respondent responses response
----------------------------------------------------------------------------------------------------------------
Reports of serious adverse drug 50 250 12,500 2 25,000
events (21 U.S.C. 379aa((b) and
(c))...........................
-------------------------------------------------------------------------------
Total....................... .............. .............. .............. .............. 25,000
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.

Section 760(e) of the FD&C Act also requires that responsible
persons maintain records of nonprescription adverse event reports,
whether or not the event is serious, for a period of 6 years. The
guidance recommends that responsible persons maintain records of
efforts to obtain the minimum data elements for a report of a serious
adverse drug event and any followup reports. Although the guidance does
not provide recommendations on recordkeeping activities generally under
section 760(e) of the FD&C Act, FDA is providing an estimate for the
burden of this collection. Historically, serious adverse event reports
comprise approximately two-thirds and nonserious adverse event reports
comprise approximately one-third of the total number of postmarketing
adverse event reports associated with drugs and biologic therapeutics
(except vaccines) received by FDA. Based on this generalization, FDA
estimates the total annual records to be approximately 20,000 records
per year. FDA estimates that it takes 5 hours to maintain each record
and the recordkeeping burden as follows:

[[Page 31025]]

Table 2--Estimated Annual Recordkeeping Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of Average
Number of records per Total annual burden per Total hours
recordkeepers recordkeeper records recordkeeping
----------------------------------------------------------------------------------------------------------------
Recordkeeping (21 U.S.C. 200 100 20,000 5 100,000
379aa(e)(1))...................
-------------------------------------------------------------------------------
Total....................... .............. .............. .............. .............. 100,000
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.

Therefore, the estimated annual reporting burden for this
information is 25,000 hours and the estimated annual recordkeeping
burden is 100,000 hours.

Dated: May 17, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-12589 Filed 5-23-12; 8:45 am]
BILLING CODE 4160-01-P

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