Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Generic Food and Drug Administration Rapid Response Surveys, 78251-78252 [2010-31381]

Download as PDF Federal Register / Vol. 75, No. 240 / Wednesday, December 15, 2010 / Notices Dated: December 8, 2010. Leslie Kux, Acting Assistant, Commissioner for Policy. 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: [FR Doc. 2010–31380 Filed 12–14–10; 8:45 am] BILLING CODE P Generic Food and Drug Administration Rapid Response Surveys—(OMB Control Number 0910–0500)—Extension DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2010–N–0380] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Generic Food and Drug Administration Rapid Response Surveys 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 January 14, 2011. 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 e-mailed to oira_ submission@omb.eop.gov. All comments should be identified with the OMB control number 0910–0500. Also include the FDA docket number found in brackets in the heading of this document. 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. SUMMARY: Section 505 of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 355), requires that important safety information relating to all human prescription drug products be made available to FDA so that it can take appropriate action to protect the public health when necessary. Section 702 of the FD&C Act (21 U.S.C. 372) authorizes investigational powers to FDA for enforcement of the FD&C Act. Under section 519 of the FD&C Act (21 U.S.C. 360i), FDA is authorized to require manufacturers to report medical devicerelated deaths, serious injuries, and malfunctions to FDA; to require user facilities to report device-related deaths directly to FDA and to manufacturers; and to report serious injuries to the manufacturer. Section 522 of the FD&C Act (21 U.S.C. 360l) authorizes FDA to require manufacturers to conduct postmarket surveillance of medical devices. Section 705(b) of the FD&C Act (21 U.S.C. 375(b)) authorizes FDA to collect and disseminate information regarding medical products or cosmetics in situations involving imminent danger to health or gross deception of the consumer. Section 903(d)(2) of the FD&C Act (21 U.S.C. 393(d)(2)) authorizes the Commissioner of Food and Drugs to implement general powers (including conducting research) to carry out effectively the mission of FDA. These sections of the FD&C Act enable FDA to enhance consumer protection from risks associated with medical products usage that are not foreseen or apparent during the premarket notification and review process. FDA’s regulations governing application for Agency approval to market a new drug (21 CFR part 314) and regulations 78251 governing biological products (21 CFR part 600) implement these statutory provisions. Currently, FDA monitors medical product related postmarket adverse events via both the mandatory and voluntary MedWatch reporting systems using FDA Forms 3500 and 3500A (OMB control number 0910– 0291) and the vaccine adverse event reporting system. FDA is seeking OMB clearance to collect vital information via a series of rapid response surveys. Participation in these surveys will be voluntary. This request covers rapid response surveys for community based health care professionals, general type medical facilities, specialized medical facilities (those known for cardiac surgery, obstetrics/gynecology services, pediatric services, etc.), other health care professionals, patients, consumers, and risk managers working in medical facilities. FDA will use the information gathered from these surveys to obtain quickly vital information about medical product risks and interventions to reduce risks so the Agency may take appropriate public health or regulatory action including dissemination of this information as necessary and appropriate. FDA projects 6 emergency risk related surveys per year with a sample of between 50 and 10,000 respondents per survey. FDA also projects a response time of 0.5 hours per response. These estimates are based on the maximum sample size per questionnaire that FDA may be able to obtain by working with health care professional organizations. The annual number of surveys was determined by the maximum number of surveys per year FDA has ever conducted under this collection. In the Federal Register of August 6, 2010 (75 FR 47599), FDA published a 60-day notice requesting public comment on the proposed collection of information. No comments were received. FDA estimates the burden of this collection of information as follows: TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1 Annual frequency per response Total annual responses Hours per response Total hours 10,000 .............................................................................................................. hsrobinson on DSK69SOYB1PROD with NOTICES Number of respondents 26 60,000 .5 30,000 1 There are no capital costs or operating and maintenance costs associated with this collection of information. 2 Maximum. VerDate Mar<15>2010 19:10 Dec 14, 2010 Jkt 223001 PO 00000 Frm 00049 Fmt 4703 Sfmt 4703 E:\FR\FM\15DEN1.SGM 15DEN1 78252 Federal Register / Vol. 75, No. 240 / Wednesday, December 15, 2010 / Notices Dated: December 8, 2010. Leslie Kux, Acting Assistant Commissioner for Policy. [FR Doc. 2010–31381 Filed 12–14–10; 8:45 am] BILLING CODE P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2010–N–0418] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Institutional Review Boards 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 January 14, 2011. ADDRESSES: To ensure that comments on the information collection are received, OMB recommends that written SUMMARY: comments be faxed to the Office of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, FAX: 202–395–7285, or e-mailed to oira_submission@omb.eop.gov. All comments should be identified with the OMB control number 0910–0130. Also include the FDA docket number found in brackets in the heading of this document. FOR FURTHER INFORMATION CONTACT: Elizabeth Berbakos, Office of Information Management, Food and Drug Administration, 1350 Piccard Dr., PI50–400B, Rockville, MD 20850,. 301– 796–3792. Elizabeth.Berbakos@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. Institutional Review Boards—OMB Control Number 0910–0130—Extension When reviewing clinical research studies regulated by FDA, institutional review boards (IRBs) are required to create and maintain records describing their operations, and make the records available for FDA inspection when requested. These records include: Written procedures describing the structure and membership of the IRB and the methods that the IRB will use in performing its functions; the research protocols, informed consent documents, progress reports, and reports of injuries to subjects submitted by investigators to the IRB; minutes of meetings showing attendance, votes and decisions made by the IRB, the number of votes on each decision for, against, and abstaining, the basis for requiring changes in or disapproving research; records of continuing review activities; copies of all correspondence between investigators and the IRB; statement of significant new findings provided to subjects of the research; and a list of IRB members by name, showing each member’s earned degrees, representative capacity, and experience in sufficient detail to describe each member’s contributions to the IRB’s deliberations, and any employment relationship between each member and the IRB’s institution. This information is used by FDA in conducting audit inspections of IRBs to determine whether IRBs and clinical investigators are providing adequate protections to human subjects participating in clinical research. In the Federal Register of August 17, 2010 (75 FR 50766), FDA published a 60-day notice requesting public comment on the proposed collection of information. No comments were received regarding the information collection. FDA estimates the burden of this collection of information as follows: TABLE 1—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1 Number of recordkeepers 21 CFR section Annual frequency per recordkeeping Total annual records Hours per recordkeeper Total hours 56.115 ........................................................................ 2,500 14.6 36,500 100 3,650,000 Total .................................................................... .......................... .......................... .......................... .......................... 3,650,000 1 There are no capital costs or operating and maintenance costs associated with this collection of information. hsrobinson on DSK69SOYB1PROD with NOTICES The recordkeeping requirement burden is based on the following: The burden for each of the paragraphs under 21 CFR 56.115 has been considered as one estimated burden. FDA estimates that there are approximately 2,500 IRBs. The IRBs meet on an average of 14.6 times annually. The agency estimates that approximately 100 hours of persontime per meeting are required to meet the requirements of the regulation. Dated: December 8, 2010. Leslie Kux, Acting Assistant, Commissioner for Policy. Food and Drug Administration information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995. [Docket No. FDA–2010–N–0184] DATES: DEPARTMENT OF HEALTH AND HUMAN SERVICES Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Experimental Study of Patient Information Prototypes AGENCY: Food and Drug Administration, HHS. Notice. [FR Doc. 2010–31389 Filed 12–14–10; 8:45 am] ACTION: BILLING CODE P SUMMARY: VerDate Mar<15>2010 The Food and Drug Administration (FDA) is announcing that a proposed collection of 19:10 Dec 14, 2010 Jkt 223001 PO 00000 Frm 00050 Fmt 4703 Sfmt 4703 Fax written comments on the collection of information by January 14, 2011. 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 e-mailed to oira_submission@omb.eop.gov. All comments should be identified with the OMB control number 0910–new and title ‘‘Experimental Study of Patient Information Prototypes.’’ Also include ADDRESSES: E:\FR\FM\15DEN1.SGM 15DEN1

Agencies

[Federal Register Volume 75, Number 240 (Wednesday, December 15, 2010)]
[Notices]
[Pages 78251-78252]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-31381]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-N-0380]

Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Generic Food and Drug
Administration Rapid Response Surveys

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 January
14, 2011.

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 e-mailed to oira_submission@omb.eop.gov. All
comments should be identified with the OMB control number 0910-0500.
Also include the FDA docket number found in brackets in the heading of
this document.

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.

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.
Generic Food and Drug Administration Rapid Response Surveys--(OMB
Control Number 0910-0500)--Extension
Section 505 of the Federal Food, Drug, and Cosmetic Act (the FD&C
Act) (21 U.S.C. 355), requires that important safety information
relating to all human prescription drug products be made available to
FDA so that it can take appropriate action to protect the public health
when necessary. Section 702 of the FD&C Act (21 U.S.C. 372) authorizes
investigational powers to FDA for enforcement of the FD&C Act. Under
section 519 of the FD&C Act (21 U.S.C. 360i), FDA is authorized to
require manufacturers to report medical device-related deaths, serious
injuries, and malfunctions to FDA; to require user facilities to report
device-related deaths directly to FDA and to manufacturers; and to
report serious injuries to the manufacturer. Section 522 of the FD&C
Act (21 U.S.C. 360l) authorizes FDA to require manufacturers to conduct
postmarket surveillance of medical devices. Section 705(b) of the FD&C
Act (21 U.S.C. 375(b)) authorizes FDA to collect and disseminate
information regarding medical products or cosmetics in situations
involving imminent danger to health or gross deception of the consumer.
Section 903(d)(2) of the FD&C Act (21 U.S.C. 393(d)(2)) authorizes the
Commissioner of Food and Drugs to implement general powers (including
conducting research) to carry out effectively the mission of FDA. These
sections of the FD&C Act enable FDA to enhance consumer protection from
risks associated with medical products usage that are not foreseen or
apparent during the premarket notification and review process. FDA's
regulations governing application for Agency approval to market a new
drug (21 CFR part 314) and regulations governing biological products
(21 CFR part 600) implement these statutory provisions. Currently, FDA
monitors medical product related postmarket adverse events via both the
mandatory and voluntary MedWatch reporting systems using FDA Forms 3500
and 3500A (OMB control number 0910-0291) and the vaccine adverse event
reporting system. FDA is seeking OMB clearance to collect vital
information via a series of rapid response surveys. Participation in
these surveys will be voluntary. This request covers rapid response
surveys for community based health care professionals, general type
medical facilities, specialized medical facilities (those known for
cardiac surgery, obstetrics/gynecology services, pediatric services,
etc.), other health care professionals, patients, consumers, and risk
managers working in medical facilities. FDA will use the information
gathered from these surveys to obtain quickly vital information about
medical product risks and interventions to reduce risks so the Agency
may take appropriate public health or regulatory action including
dissemination of this information as necessary and appropriate.
FDA projects 6 emergency risk related surveys per year with a
sample of between 50 and 10,000 respondents per survey. FDA also
projects a response time of 0.5 hours per response. These estimates are
based on the maximum sample size per questionnaire that FDA may be able
to obtain by working with health care professional organizations. The
annual number of surveys was determined by the maximum number of
surveys per year FDA has ever conducted under this collection.
In the Federal Register of August 6, 2010 (75 FR 47599), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. No comments were received.
FDA estimates the burden of this collection of information as
follows:

Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
Annual
Number of respondents frequency per Total annual Hours per Total hours
response responses response
----------------------------------------------------------------------------------------------------------------
10,000...................................... \2\ 6 60,000 .5 30,000
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
\2\ Maximum.

[[Page 78252]]

Dated: December 8, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-31381 Filed 12-14-10; 8:45 am]
BILLING CODE P

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