Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Postmarketing Adverse Drug Experience Reporting, 38303-38305 [2012-15708]

Download as PDF Federal Register / Vol. 77, No. 124 / Wednesday, June 27, 2012 / Notices 38303 DEPARTMENT OF HEALTH AND HUMAN SERVICES DEPARTMENT OF HEALTH AND HUMAN SERVICES DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Food and Drug Administration Food and Drug Administration [Docket No. FDA–2011–N–0793] [Docket No. FDA–2010–N–0465] Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Medical Device Recall Authority Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Experimental Study: Effect of Promotional Offers in Direct-toConsumer Prescription Drug Print Advertisements on Consumer Product Perceptions [Docket No. FDA–2011–N–0797] AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is announcing that a collection of information entitled ‘‘Medical Device Recall Authority’’ has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995. SUMMARY: FOR FURTHER INFORMATION CONTACT: Daniel Gittleson, Office of Information Management, Food and Drug Administration, 1350 Piccard Dr., PI50– 400B, Rockville, MD 20850, 301–796– 5156, Daniel.Gittleson@fda.hhs.gov. On February 13, 2012, the Agency submitted a proposed collection of information entitled ‘‘Medical Device Recall Authority’’ to OMB for review and clearance under 44 U.S.C. 3507. An Agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. OMB has now approved the information collection and has assigned OMB control number 0910–0432. The approval expires on June 30, 2015. A copy of the supporting statement for this information collection is available on the Internet at https://www.reginfo.gov/ public/do/PRAMain. SUPPLEMENTARY INFORMATION: Dated: June 18, 2012. Leslie Kux, Assistant Commissioner for Policy. [FR Doc. 2012–15717 Filed 6–26–12; 8:45 am] srobinson on DSK4SPTVN1PROD with NOTICES BILLING CODE 4160–01–P AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is announcing that a collection of information entitled ‘‘Experimental Study: Effect of Promotional Offers in Direct-toConsumer Prescription Drug Print Advertisements on Consumer Product Perceptions’’ has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995. SUMMARY: 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. On October 14, 2011, the Agency submitted a proposed collection of information entitled ‘‘Experimental Study: Effect of Promotional Offers in Direct-toConsumer Prescription Drug Print Advertisements on Consumer Product Perceptions’’ to OMB for review and clearance under 44 U.S.C. 3507. An Agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. OMB has now approved the information collection and has assigned OMB control number 0910–0713. The approval expires on June 30, 2015. A copy of the supporting statement for this information collection is available on the Internet at https://www.reginfo.gov/ public/do/PRAMain. SUPPLEMENTARY INFORMATION: Dated: June 18, 2012. Leslie Kux, Assistant Commissioner for Policy. [FR Doc. 2012–15715 Filed 6–26–12; 8:45 am] BILLING CODE 4160–01–P VerDate Mar<15>2010 19:05 Jun 26, 2012 Jkt 226001 PO 00000 Frm 00037 Fmt 4703 Sfmt 4703 Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; State Enforcement Notifications AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is announcing that a collection of information entitled ‘‘State Enforcement Notifications’’ has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995. FOR FURTHER INFORMATION CONTACT: Denver Presley, II, Office of Information Management, Food and Drug Administration, 1350 Piccard Dr., PI50– 400B, Rockville, MD 20850, 301–796– 3793. SUPPLEMENTARY INFORMATION: On March 19, 2012, the Agency submitted a proposed collection of information entitled ‘‘State Enforcement Notifications’’ to OMB for review and clearance under 44 U.S.C. 3507. An Agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. OMB has now approved the information collection and has assigned OMB control number 0910–0275. The approval expires on June 30, 2015. A copy of the supporting statement for this information collection is available on the Internet at https://www.reginfo.gov/ public/do/PRAMain. SUMMARY: Dated: June 18, 2012. Leslie Kux, Assistant Commissioner for Policy. [FR Doc. 2012–15707 Filed 6–26–12; 8:45 am] BILLING CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2012–N–0253] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Postmarketing Adverse Drug Experience Reporting AGENCY: Food and Drug Administration, HHS. ACTION: E:\FR\FM\27JNN1.SGM Notice. 27JNN1 38304 Federal Register / Vol. 77, No. 124 / Wednesday, June 27, 2012 / Notices 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 July 27, 2012. SUMMARY: 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 0910–0230. Also include the FDA docket number found in brackets in the heading of this document. ADDRESSES: 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. In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance. SUPPLEMENTARY INFORMATION: Postmarketing Adverse Drug Experience Reporting—21 CFR 310.305 and 314.80—(OMB Control Number 0910–0230)—(Extension) Sections 201, 502, 505, and 701 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321, 352, 355, and 371) require that marketed drugs be safe and effective. In order to know whether drugs that are not safe and effective are on the market, FDA must be promptly informed of adverse experiences occasioned by the use of marketed drugs. In order to help ensure this, FDA issued regulations at §§ 310.305 and 314.80 (21 CFR 310.305 and 314.80) to impose reporting and recordkeeping requirements on the drug industry that would enable FDA to take the action necessary to protect the public health from adverse drug experiences. All applicants who have received marketing approval of drug products are required to report to FDA serious, unexpected adverse drug experiences, as well as follow up reports when needed (§ 314.80(c)(1)). This includes reports of all foreign or domestic adverse experiences as well as those based on information from applicable scientific literature and certain reports from postmarketing studies. Section 314.80(c)(1)(iii) pertains to such reports submitted by nonapplicants. Under § 314.80(c)(2) applicants must provide periodic reports of adverse drug experiences. A periodic report includes, for the reporting interval, reports of serious, expected adverse drug experiences and all nonserious adverse drug experiences and an index of these reports, a narrative summary and analysis of adverse drug experiences, and a history of actions taken because of adverse drug experiences. Under § 314.80(i), applicants must keep for 10 years records of all adverse drug experience reports known to the applicant. For marketed prescription drug products without approved new drug applications or abbreviated new drug applications, manufacturers, packers, and distributors are required to report to FDA serious, unexpected adverse drug experiences as well as follow-up reports when needed (§ 310.305(c)). Section 310.305(c)(5) pertains to the submission of follow-up reports to reports forwarded by FDA. Under § 310.305(f), each manufacturer, packer, and distributor shall maintain for 10 years records of all adverse drug experiences required to be reported. The primary purpose of FDA’s adverse drug experience reporting system is to provide a signal for potentially serious safety problems with marketed drugs. Although premarket testing discloses a general safety profile of a new drug’s comparatively common adverse effects, the larger and more diverse patient populations exposed to the marketed drug provide the opportunity to collect information on rare, latent, and long-term effects. Signals are obtained from a variety of sources, including reports from patients, treating physicians, foreign regulatory agencies, and clinical investigators. Information derived from the adverse drug experience reporting system contributes directly to increased public health protection because the information enables FDA to make important changes to the product’s labeling (such as adding a new warning), decisions about risk evaluation and mitigation strategies or the need for postmarket studies or clinical trials, and when necessary, to initiate removal of a drug from the market. Respondents to this collection of information are manufacturers, packers, distributors, and applicants. In the Federal Register of March 20, 2012 (77 FR 16232), FDA published a 60-day notice requesting public comment on the proposed collection of information. FDA received several comments, but they did not pertain to the information collection in 21 CFR 310.305(c)(5) and (f), and 314.80(c)(1)(iii), (c)(2), and (i). FDA estimates the burden of this collection of information as follows: TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1 Number of responses per respondent Number of respondents 21 CFR Section Total annual responses Average burden per response Total hours 310.305(c)(5) .................................................... 314.80(c)(1)(iii) ................................................. 314.80(c)(2) ...................................................... 3 5 665 1 1 22.85 3 5 15,195 1 1 60 3 5 911,700 Total .......................................................... ............................ ............................ ............................ ............................ 911,708 srobinson on DSK4SPTVN1PROD with NOTICES 1 The reporting burden for §§ 310.305(c)(1), (c)(2), and (c)(3), and 314.80(c)(1)(i) and (c)(1)(ii) is reported under OMB No. 0910–0291. The capital costs or operating and maintenance costs associated with this collection of information are approximately $25,000 annually. TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1 Number of recordkeepers 21 CFR Section 310.305(f) ......................................................... VerDate Mar<15>2010 19:05 Jun 26, 2012 Jkt 226001 PO 00000 Number of records per recordkeeper 25 Frm 00038 Fmt 4703 1 Sfmt 4703 Average burden per recordkeeping Total annual records 25 E:\FR\FM\27JNN1.SGM 27JNN1 16 Total hours 400 38305 Federal Register / Vol. 77, No. 124 / Wednesday, June 27, 2012 / Notices TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1—Continued Number of recordkeepers 21 CFR Section Number of records per recordkeeper Average burden per recordkeeping Total annual records Total hours 314.80(i) ........................................................... 665 601.5 399,998 16 6,399,968 Total .......................................................... ............................ ............................ ............................ ............................ 6,400,368 1 There are no capital costs or operating costs associated with this collection of information. There are maintenance costs of $22,000 annually. These estimates are based on FDA’s knowledge of adverse drug experience reporting, including the time needed to prepare the reports, and the number of reports submitted to the Agency. Dated: June 22, 2012. Leslie Kux, Assistant Commissioner for Policy. information collection and has assigned OMB control number 0910–0710. The approval expires on June 30, 2014. A copy of the supporting statement for this information collection is available on the Internet at https://www.reginfo.gov/ public/do/PRAMain. Dated: June 18, 2012. Leslie Kux, Assistant Commissioner for Policy. [FR Doc. 2012–15708 Filed 6–26–12; 8:45 am] BILLING CODE 4160–01–P [FR Doc. 2012–15714 Filed 6–26–12; 8:45 am] BILLING CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2010–N–0640] Food and Drug Administration Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Data To Support Food and Nutrition Product Communications as Used by the Food and Drug Administration Dated: June 20, 2012. Leslie Kux, Assistant Commissioner for Policy. [FR Doc. 2012–15696 Filed 6–26–12; 8:45 am] [Docket No. FDA–2009–N–0535] AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is announcing that a collection of information entitled ‘‘Data to Support Food and Nutrition Product Communications as Used by the Food and Drug Administration’’ has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995. FOR FURTHER INFORMATION CONTACT: Denver Presley II, Office of Information Management, Food and Drug Administration, 1350 Piccard Dr., PI50– 400B, Rockville, MD 20850, 301–796– 3793. SUPPLEMENTARY INFORMATION: On May 27, 2011, the Agency submitted a proposed collection of information entitled ‘‘Data to Support Food and Nutrition Product Communications as Used by the Food and Drug Administration’’ to OMB for review and clearance under 44 U.S.C. 3507. An Agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. OMB has now approved the SUMMARY: srobinson on DSK4SPTVN1PROD with NOTICES Agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. OMB has now approved the information collection and has assigned OMB control number 0910–0711. The approval expires on October 31, 2013. A copy of the supporting statement for this information collection is available on the Internet at https://www.reginfo.gov/ public/do/PRAMain. VerDate Mar<15>2010 19:05 Jun 26, 2012 Jkt 226001 Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; ‘‘Real Time’’ Surveys of Consumers’ Knowledge, Perceptions and Reported Behavior Concerning Foodborne Illness Outbreaks or Food Recalls AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is announcing that a collection of information entitled ‘‘‘Real Time’ Surveys of Consumers’ Knowledge, Perceptions and Reported Behavior Concerning Foodborne Illness Outbreaks or Food Recalls’’ has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995. FOR FURTHER INFORMATION CONTACT: Denver Presley II, Office of Information Management, Food and Drug Administration, 1350 Piccard Dr., PI50– 400B, Rockville, MD 20850, 301–796– 3793. SUPPLEMENTARY INFORMATION: On June 27, 2011, the Agency submitted a proposed collection of information entitled ‘‘‘Real Time’ Surveys of Consumers’ Knowledge, Perceptions and Reported Behavior Concerning Foodborne Illness Outbreaks or Food Recalls’’ to OMB for review and clearance under 44 U.S.C. 3507. An SUMMARY: PO 00000 Frm 00039 Fmt 4703 Sfmt 4703 BILLING CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2010–D–0249] Guidance for Industry on Lupus Nephritis Caused by Systemic Lupus Erythematosus—Developing Medical Products for Treatment; Withdrawal of Guidance AGENCY: Food and Drug Administration, HHS. ACTION: Notice; withdrawal. The Food and Drug Administration (FDA) is announcing the withdrawal of a guidance published in the Federal Register of June 22, 2010. DATES: June 27, 2012. FOR FURTHER INFORMATION CONTACT: Leila P. Hann, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave. Bldg. 22, rm. 3143, Silver Spring, MD 20993–0002, 301– 796–3367; or Philip Desjardins, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave. Bldg. 66, rm. 5437, Silver Spring, MD 20993–0002, 301– 796–5678; or Stephen Ripley, Center for Biologics Evaluation and Research (HFM–17), SUMMARY: E:\FR\FM\27JNN1.SGM 27JNN1

Agencies

[Federal Register Volume 77, Number 124 (Wednesday, June 27, 2012)]
[Notices]
[Pages 38303-38305]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-15708]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-N-0253]

Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Postmarketing Adverse
Drug Experience Reporting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

[[Page 38304]]

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 July
27, 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 0910-0230.
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.

Postmarketing Adverse Drug Experience Reporting--21 CFR 310.305 and
314.80--(OMB Control Number 0910-0230)--(Extension)

Sections 201, 502, 505, and 701 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 321, 352, 355, and 371) require that marketed
drugs be safe and effective. In order to know whether drugs that are
not safe and effective are on the market, FDA must be promptly informed
of adverse experiences occasioned by the use of marketed drugs. In
order to help ensure this, FDA issued regulations at Sec. Sec. 310.305
and 314.80 (21 CFR 310.305 and 314.80) to impose reporting and
recordkeeping requirements on the drug industry that would enable FDA
to take the action necessary to protect the public health from adverse
drug experiences.
All applicants who have received marketing approval of drug
products are required to report to FDA serious, unexpected adverse drug
experiences, as well as follow up reports when needed (Sec.
314.80(c)(1)). This includes reports of all foreign or domestic adverse
experiences as well as those based on information from applicable
scientific literature and certain reports from postmarketing studies.
Section 314.80(c)(1)(iii) pertains to such reports submitted by
nonapplicants. Under Sec. 314.80(c)(2) applicants must provide
periodic reports of adverse drug experiences. A periodic report
includes, for the reporting interval, reports of serious, expected
adverse drug experiences and all nonserious adverse drug experiences
and an index of these reports, a narrative summary and analysis of
adverse drug experiences, and a history of actions taken because of
adverse drug experiences. Under Sec. 314.80(i), applicants must keep
for 10 years records of all adverse drug experience reports known to
the applicant.
For marketed prescription drug products without approved new drug
applications or abbreviated new drug applications, manufacturers,
packers, and distributors are required to report to FDA serious,
unexpected adverse drug experiences as well as follow-up reports when
needed (Sec. 310.305(c)). Section 310.305(c)(5) pertains to the
submission of follow-up reports to reports forwarded by FDA. Under
Sec. 310.305(f), each manufacturer, packer, and distributor shall
maintain for 10 years records of all adverse drug experiences required
to be reported.
The primary purpose of FDA's adverse drug experience reporting
system is to provide a signal for potentially serious safety problems
with marketed drugs. Although premarket testing discloses a general
safety profile of a new drug's comparatively common adverse effects,
the larger and more diverse patient populations exposed to the marketed
drug provide the opportunity to collect information on rare, latent,
and long-term effects. Signals are obtained from a variety of sources,
including reports from patients, treating physicians, foreign
regulatory agencies, and clinical investigators. Information derived
from the adverse drug experience reporting system contributes directly
to increased public health protection because the information enables
FDA to make important changes to the product's labeling (such as adding
a new warning), decisions about risk evaluation and mitigation
strategies or the need for postmarket studies or clinical trials, and
when necessary, to initiate removal of a drug from the market.
Respondents to this collection of information are manufacturers,
packers, distributors, and applicants.
In the Federal Register of March 20, 2012 (77 FR 16232), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. FDA received several comments, but they did
not pertain to the information collection in 21 CFR 310.305(c)(5) and
(f), and 314.80(c)(1)(iii), (c)(2), and (i).
FDA estimates the burden of this collection of information as
follows:

Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
21 CFR Section Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
--------------------------------------------------------------------------------------------------------------------------------------------------------
310.305(c)(5)................................................. 3 1 3 1 3
314.80(c)(1)(iii)............................................. 5 1 5 1 5
314.80(c)(2).................................................. 665 22.85 15,195 60 911,700
-----------------------------------------------------------------------------------------
Total..................................................... ................ ................ ................ ................ 911,708
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ The reporting burden for Sec. Sec. 310.305(c)(1), (c)(2), and (c)(3), and 314.80(c)(1)(i) and (c)(1)(ii) is reported under OMB No. 0910-0291. The
capital costs or operating and maintenance costs associated with this collection of information are approximately $25,000 annually.

Table 2--Estimated Annual Recordkeeping Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of Average burden
21 CFR Section Number of records per Total annual per Total hours
recordkeepers recordkeeper records recordkeeping
--------------------------------------------------------------------------------------------------------------------------------------------------------
310.305(f).................................................... 25 1 25 16 400

[[Page 38305]]

314.80(i)..................................................... 665 601.5 399,998 16 6,399,968
-----------------------------------------------------------------------------------------
Total..................................................... ................ ................ ................ ................ 6,400,368
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating costs associated with this collection of information. There are maintenance costs of $22,000 annually.

These estimates are based on FDA's knowledge of adverse drug
experience reporting, including the time needed to prepare the reports,
and the number of reports submitted to the Agency.

Dated: June 22, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-15708 Filed 6-26-12; 8:45 am]
BILLING CODE 4160-01-P

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