Agency Information Collection Activities; Proposed Collection; Comment Request; Reports of Corrections and Removals, 70327-70328 [E7-23962]

Download as PDF Federal Register / Vol. 72, No. 237 / Tuesday, December 11, 2007 / Notices FOR FURTHER INFORMATION CONTACT: DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2007N–0460] Agency Information Collection Activities; Proposed Collection; Comment Request; Reports of Corrections and Removals AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the agency. Under the Paperwork Reduction Act of 1995 (the 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 information collection requirements for reports of corrections and removal. DATES: Submit written or electronic comments on the collection of information by February 11, 2008. ADDRESSES: Submit electronic comments on the collection of information to: https://www.fda.gov/ dockets/ecomments or https:// www.regulations.gov. Submit written comments on the collection of information to the Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. All comments should be identified with the docket number found in brackets in the heading of this document. Denver Presley, Jr., Office of the Chief Information Officer (HFA–250), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301–827– 1472. SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501–3520), Federal agencies must obtain approval from 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, 70327 when appropriate, and other forms of information technology. Reports of Corrections and Removals— 21 CFR Part 806; (OMB Control Number 0910–0359)—Extension The collection of information required under the reports of corrections and removals, part 806 (21 CFR part 806), implements section 519(f) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 360i(f)), as amended by the Food and Drug Modernization Act of 1997 (FDAMA) (21 U.S.C. 301) (Public Law 105–115). Each device manufacturer or importer under § 806.10 shall submit a written report to FDA of any action initiated to correct or remove a device to reduce a risk to health posed by the device, or to remedy a violation of the act caused by the device which may present a risk to health, within 10 working days of initiating such correction or removal. Each device manufacturer or importer of a device who initiates a correction or removal of a device that is not required to be reported to FDA under § 806.20 shall keep a record of such correction or removal. The information collected in the reports of corrections and removals will be used by FDA to identify marketed devices that have serious problems and to ensure that defective devices are removed from the market. This will assure that FDA has current and complete information regarding these corrections and removals and to determine whether recall action is adequate. Respondents to this collection of information are manufacturers and importers of medical devices. FDA estimates the burden for this collection of information as follows: TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1 No. of Respondents 21 CFR Section 806.10 Annual Frequency per Response 488 1 Total Annual Responses Hours per Response 488 Total Hours 10 TOTAL 1 There 4,880 4,880 are no capital costs or operating and maintenance costs associated with this collection of information. TABLE 2.—ESTIMATED ANNUAL RECORDKEEPING BURDEN1 No. of Recordkeepers pwalker on PROD1PC71 with NOTICES 21 CFR Section 806.20 Annual Frequency of Recordkeeping 132 1 Total Annual Records Hours per Record 132 10 TOTAL 1 There Total Hours 1,320 1,320 are no capital costs or operating and maintenance costs associated with this collection of information. VerDate Aug<31>2005 19:12 Dec 10, 2007 Jkt 214001 PO 00000 Frm 00039 Fmt 4703 Sfmt 4703 E:\FR\FM\11DEN1.SGM 11DEN1 70328 Federal Register / Vol. 72, No. 237 / Tuesday, December 11, 2007 / Notices In preparing the previous clearances for approval of the information collection requirements under §§ 806.10 and 806.20, FDA reviewed the reports of corrections and removals submitted for the previous 3 years under part 7 (21 CFR part 7), the agency’s recall provisions. FDA has determined that estimates of the reporting burden in § 806.10 should be revised to reflect a 1.2 percent increase for reports and records submitted under 21 CFR part 7 due to a decrease in class I and class II recall actions. FDA also estimates the reporting burden in § 806.20 should be revised to reflect a reduction of 8 percent for reports and records submitted under 21 CFR part 7 due to a decrease in class III recall actions. The time needed to collect information has not been changed. Please note that in January 2008, the FDA Web site is expected to transition to the Federal Dockets Management System (FDMS). FDMS is a Government-wide, electronic docket management system. After the transition date, electronic submissions will be accepted by FDA through the FDMS only. When the exact date of the transition to FDMS is known, FDA will publish a Federal Register notice announcing that date. Dated: December 5, 2007. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E7–23962 Filed 12–10–07; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2007N–0461] Agency Information Collection Activities; Proposed Collection; Comment Request; Mental Models Study of Communicating With Health Care Providers About the Risks and Benefits of Prescription Drug Use for Pregnant and Nursing Women With Chronic Conditions AGENCY: Food and Drug Administration, HHS. pwalker on PROD1PC71 with NOTICES ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal agencies are required to publish notice in the Federal Register concerning each proposed collection of VerDate Aug<31>2005 19:12 Dec 10, 2007 Jkt 214001 information and to allow 60 days for public comment in response to the notice. This notice solicits comments on the information collection provisions of the Mental Models Study of Communicating With Health Care Providers About the Risks and Benefits of Prescription Drug Use for Pregnant and Nursing Women With Chronic Conditions. Together with other information being collected, the results from this study will be used to help inform FDA about how health care providers use prescription drug labeling and other available information in making treatment decisions and how that use differs from how agency experts believe such information is used. It will also contribute to FDA’s ability to plan internal and external communications activities that address any misperceptions and gaps in understanding about prescription drug labeling. Submit written or electronic comments on the collection of information by February 11, 2008. ADDRESSES: Submit electronic comments on the collection of information to: https://www.fda.gov/ dockets/ecomments. Submit written comments on the collection of information to the Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. All comments should be identified with the docket number found in brackets in the heading of this document. FOR FURTHER INFORMATION CONTACT: Jonna Capezutto, Office of the Chief Information Officer (HFA–250), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301–827– 4659. DATES: 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 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. SUPPLEMENTARY INFORMATION: PO 00000 Frm 00040 Fmt 4703 Sfmt 4703 With respect to the following collection of information, FDA invites comments on: (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. Mental Models Study of Communicating With Health Care Providers About the Risks and Benefits of Prescription Drug Use for Pregnant and Nursing Women With Chronic Conditions The authority for FDA to collect the information derives from the FDA Commissioner’s authority, as specified in section 903(d)(2) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 393(d)(2)). The proposed information collection will help FDA advance public health by identifying misperceptions and knowledge gaps about how health care providers use information to make decisions about the use of prescription drugs for the targeted patient groups. Knowledge of these misperceptions and gaps provides opportunities for FDA to target its communications more precisely to such gaps and areas of misperception in health care providers’ mental models regarding treatment decisions. FDA engages in various communication activities to ensure that patients and health care providers have the information they need to make informed decisions about treatment options, including the use of prescription drugs. FDA regulations (21 CFR § 201.57) describe the content of required product labeling, and FDA reviewers ensure that labeling contains accurate and complete information about the known risks and benefits of each drug. This data collection and analysis is designed to identify knowledge gaps that FDA could then address, which would ultimately improve decision making and potentially improve health outcomes. The project will use ‘‘mental modeling,’’ a qualitative research method that compares a model of the decision-making processes of a group or groups to a model of the same decision- E:\FR\FM\11DEN1.SGM 11DEN1

Agencies

[Federal Register Volume 72, Number 237 (Tuesday, December 11, 2007)]
[Notices]
[Pages 70327-70328]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-23962]

[[Page 70327]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2007N-0460]

Agency Information Collection Activities; Proposed Collection;
Comment Request; Reports of Corrections and Removals

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing an
opportunity for public comment on the proposed collection of certain
information by the agency. Under the Paperwork Reduction Act of 1995
(the 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 information collection
requirements for reports of corrections and removal.

DATES: Submit written or electronic comments on the collection of
information by February 11, 2008.

ADDRESSES: Submit electronic comments on the collection of information
to: https://www.fda.gov/dockets/ecomments or https://www.regulations.gov.
Submit written comments on the collection of information to the
Division of Dockets Management (HFA-305), Food and Drug Administration,
5630 Fishers Lane, rm. 1061, Rockville, MD 20852. All comments should
be identified with the docket number found in brackets in the heading
of this document.

FOR FURTHER INFORMATION CONTACT: Denver Presley, Jr., Office of the
Chief Information Officer (HFA-250), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857, 301-827-1472.

SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal
agencies must obtain approval from 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.

Reports of Corrections and Removals--21 CFR Part 806; (OMB Control
Number 0910-0359)--Extension

The collection of information required under the reports of
corrections and removals, part 806 (21 CFR part 806), implements
section 519(f) of the Federal Food, Drug, and Cosmetic Act (the act)
(21 U.S.C. 360i(f)), as amended by the Food and Drug Modernization Act
of 1997 (FDAMA) (21 U.S.C. 301) (Public Law 105-115). Each device
manufacturer or importer under Sec. 806.10 shall submit a written
report to FDA of any action initiated to correct or remove a device to
reduce a risk to health posed by the device, or to remedy a violation
of the act caused by the device which may present a risk to health,
within 10 working days of initiating such correction or removal. Each
device manufacturer or importer of a device who initiates a correction
or removal of a device that is not required to be reported to FDA under
Sec. 806.20 shall keep a record of such correction or removal.
The information collected in the reports of corrections and
removals will be used by FDA to identify marketed devices that have
serious problems and to ensure that defective devices are removed from
the market. This will assure that FDA has current and complete
information regarding these corrections and removals and to determine
whether recall action is adequate.
Respondents to this collection of information are manufacturers and
importers of medical devices.
FDA estimates the burden for this collection of information as
follows:

Table 1.--Estimated Annual Reporting Burden\1\
----------------------------------------------------------------------------------------------------------------
No. of Annual Frequency Total Annual Hours per
21 CFR Section Respondents per Response Responses Response Total Hours
----------------------------------------------------------------------------------------------------------------
806.10 488 1 488 10 4,880
----------------------------------------------------------------------------------------------------------------
Total ................. ................. ................. ................. 4,880
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.

Table 2.--Estimated Annual Recordkeeping Burden\1\
----------------------------------------------------------------------------------------------------------------
No. of Annual Frequency Total Annual
21 CFR Section Recordkeepers of Recordkeeping Records Hours per Record Total Hours
----------------------------------------------------------------------------------------------------------------
806.20 132 1 132 10 1,320
----------------------------------------------------------------------------------------------------------------
Total ................. ................. ................. ................. 1,320
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.

[[Page 70328]]

In preparing the previous clearances for approval of the
information collection requirements under Sec. Sec. 806.10 and 806.20,
FDA reviewed the reports of corrections and removals submitted for the
previous 3 years under part 7 (21 CFR part 7), the agency's recall
provisions. FDA has determined that estimates of the reporting burden
in Sec. 806.10 should be revised to reflect a 1.2 percent increase for
reports and records submitted under 21 CFR part 7 due to a decrease in
class I and class II recall actions. FDA also estimates the reporting
burden in Sec. 806.20 should be revised to reflect a reduction of 8
percent for reports and records submitted under 21 CFR part 7 due to a
decrease in class III recall actions. The time needed to collect
information has not been changed.
Please note that in January 2008, the FDA Web site is expected to
transition to the Federal Dockets Management System (FDMS). FDMS is a
Government-wide, electronic docket management system. After the
transition date, electronic submissions will be accepted by FDA through
the FDMS only. When the exact date of the transition to FDMS is known,
FDA will publish a Federal Register notice announcing that date.

Dated: December 5, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7-23962 Filed 12-10-07; 8:45 am]
BILLING CODE 4160-01-S

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