Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Generic Food and Drug Administration Rapid Response Surveys, 14927-14928 [E6-4262]

Download as PDF 14927 Federal Register / Vol. 71, No. 57 / Friday, March 24, 2006 / Notices of age. Providers in the control group will receive the more general technical assistance and support visits that they currently receive. Impacts on provider behavior and the home environment will be measured through direct observations in the homes. Child assessments will be conducted through provider reports for the younger children and through standardized tests for children 30 months and older. Respondents Illinois. Parents who apply (or reapply) for subsidies and are eligible and agree to be in the study will be interviewed by telephone up to three times in the 24 months after they enter the study. Washington State. Parents who apply (or reapply) for subsidies and are eligible and agree to be in the study will be interviewed by telephone up to three times over the 24 months of the study. Approximately 30 State employees working at the Department of Health and Human Services in the Division of Child Care and Early Learning or the Division of Community Service will be interviewed as part of the implementation study. Massachusetts. Children will be assessed 7 months after implementing the curriculum, after 11 months, and after 23 months. Providers will be asked to respond to a brief survey 7 and 23 months after the study begins. Home visitors, who support providers in the treatment and control groups, will be asked to respond to a brief interview at 23 months. ANNUAL BURDEN ESTIMATES Number of respondents Instrument Illinois parent survey .................................................................................... Washington parent survey ........................................................................... Washington process study interview ........................................................... Massachusetts child assessments .............................................................. Massachusetts provider interview ............................................................... Massachusetts home visitor interview ......................................................... Number of responses per respondent 2,000 2,000 30 700 350 32 Estimated Total Annual Burden Hours: 4,072. DEPARTMENT OF HEALTH AND HUMAN SERVICES Additional Information Food and Drug Administration Copies of the proposed collection may be obtained by writing to the Administration for Children and Families, Office of Administration, Office of Information Services, 370 L’Enfant Promenade, SW., Washington, DC 20447, Attn: ACF Reports Clearance Officer. All requests should be identified by the title of the information collection. E-mail address: infocollection@acf.hhs.gov. [Docket No. 2005N–0414] OMB Comment 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 April 24, 2006. ADDRESSES: OMB is still experiencing significant delays in the regular mail, including first class and express mail, and messenger deliveries are not being accepted. 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: Fumie Yokota, Desk Officer for FDA, FAX: 202–395–6974. FOR FURTHER INFORMATION CONTACT: Jonna Capezzuto, Office of Management wwhite on PROD1PC61 with NOTICES OMB is required to make a decision concerning the collection of information between 30 and 60 days after publication of this document in the Federal Register. Therefore, a comment is best assured of having its full effect if OMB receives it within 30 days of publication. Written comments and recommendations for the proposed information collection should be sent directly to the following: Office of Management and Budget, Paperwork Reduction Project, Attn: Desk Officer for ACF, E-mail address: Katherine_T._Astrich@omb.eop.gov. Dated: March 20, 2006. Robert Sargis, Reports Clearance Officer. [FR Doc. 06–2867 Filed 3–23–06; 8:45 am] BILLING CODE 4184–01–M VerDate Aug<31>2005 18:26 Mar 23, 2006 Jkt 208001 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: PO 00000 Notice. Frm 00096 Fmt 4703 Sfmt 4703 Average burden hours per response 1.5 1.5 .5 1.5 1 .5 .58 .58 .5 .5 .16 .16 Total burden hours 1,740 1,740 8 525 56 3 Programs (HFA–250), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301–827–4659. 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 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 act (21 U.S.C. 372) authorizes investigational powers to FDA for enforcement of the act. Under section 519 of the 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 act (21 U.S.C. 360l) authorizes FDA to require manufacturers to conduct postmarket surveillance of medical devices. Section 705(b) of the act (21 U.S.C. 375(b)) authorizes FDA to collect and disseminate information regarding medical products or cosmetics in E:\FR\FM\24MRN1.SGM 24MRN1 14928 Federal Register / Vol. 71, No. 57 / Friday, March 24, 2006 / Notices situations involving imminent danger to health or gross deception of the consumer. Section 903(d)(2) of the 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 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 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. In theFederal Register of October 25, 2005 (70 FR 61624), FDA published a 60-day notice requesting public comment on the information collection provisions. No comments were received. FDA estimates the burden of the collection of information as follows: 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 TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1 Annual Frequency per Response No. of Respondents 200 1There Total Annual Responses 30 (maximum) 6,000 Total Hours 0.5 3,000 are no capital costs or operating and maintenance costs associated with this collection of information. FDA projects 30 emergency risk related surveys per year with a sample of between 50 and 200 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 can analyze in a timely manner. The annual frequency of response was determined by the maximum number of questionnaires that will be sent to any individual respondent. Some respondents may be contacted only one time per year, while other respondents may be contacted several times annually, depending on the human drug, biologic, or medical device under evaluation. It is estimated that, given the expected type of issues that will be addressed by the surveys, it will take 0.5 hours for a respondent to gather the requested information and fill in the answers. Dated: March 20, 2006. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E6–4262 Filed 3–23–06; 8:45 am] DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration Agency Information Collection Activities: Submission for OMB Review; Comment Request Periodically, the Health Resources and Services Administration (HRSA) publishes abstracts of information collection requests under review by the Office of Management and Budget (OMB), in compliance with the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35). To request a copy of the clearance requests submitted to OMB for review, call the HRSA Reports Clearance Office on (301) 443–1129. The following request has been submitted to the Office of Management and Budget for review under the Paperwork Reduction Act of 1995: Proposed Project: Voluntary Partner Surveys in the Health Resources and Services Administration—(OMB No. 0915–0212)—Extension In response to Executive Order 12862, the Health Resources and Services BILLING CODE 4160–01–S In-class evaluations ......................................................................................................... Surveys ............................................................................................................................ Focus groups ................................................................................................................... VerDate Aug<31>2005 18:26 Mar 23, 2006 Jkt 208001 PO 00000 Administration (HRSA) conducts voluntary customer surveys of its ‘‘partners’’ to assess strengths and weaknesses in program services. An extension of a generic approval is being requested from OMB to conduct these customer or partner satisfaction surveys. HRSA partners are typically State or local governments, health care facilities, health care consortia, health care providers, and researchers. Partner surveys to be conducted by HRSA might include, for example, brief surveys of grantees to determine satisfaction with a technical assistance contractor, or in-class evaluation forms completed by providers who receive training from HRSA grantees, to measure satisfaction with the training experience. Results of these surveys will be used to plan and redirect resources and efforts as needed to improve service. Focus groups may also be used to potential method to obtain input on services and training. Focus groups, inclass evaluation forms, mail surveys, and telephone surveys are expected to be the preferred methodologies. The estimated response burden is as follows: Number of respondents Instrument wwhite on PROD1PC61 with NOTICES Hours per Response Frm 00097 Fmt 4703 Sfmt 4703 Responses per respondent 40,000 12,000 50 1 1 1 E:\FR\FM\24MRN1.SGM 24MRN1 Hours per response .05 .25 1.5 Total hour burden 2,000 3,000 75

Agencies

[Federal Register Volume 71, Number 57 (Friday, March 24, 2006)]
[Notices]
[Pages 14927-14928]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-4262]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2005N-0414]

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 April
24, 2006.

ADDRESSES: OMB is still experiencing significant delays in the regular
mail, including first class and express mail, and messenger deliveries
are not being accepted. 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: Fumie
Yokota, Desk Officer for FDA, FAX: 202-395-6974.

FOR FURTHER INFORMATION CONTACT: Jonna Capezzuto, Office of Management
Programs (HFA-250), Food and Drug Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301-827-4659.

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 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 act (21 U.S.C. 372) authorizes
investigational powers to FDA for enforcement of the act. Under section
519 of the 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 act (21
U.S.C. 360l) authorizes FDA to require manufacturers to conduct
postmarket surveillance of medical devices. Section 705(b) of the act
(21 U.S.C. 375(b)) authorizes FDA to collect and disseminate
information regarding medical products or cosmetics in

[[Page 14928]]

situations involving imminent danger to health or gross deception of
the consumer.
Section 903(d)(2) of the 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 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.
In theFederal Register of October 25, 2005 (70 FR 61624), FDA
published a 60-day notice requesting public comment on the information
collection provisions. No comments were received.
FDA estimates the burden of the collection of information as
follows:

Table 1.--Estimated Annual Reporting Burden\1\
----------------------------------------------------------------------------------------------------------------
Annual Frequency Total Annual Hours per
No. of Respondents per Response Responses Response Total Hours
----------------------------------------------------------------------------------------------------------------
200 30 (maximum) 6,000 0.5 3,000
----------------------------------------------------------------------------------------------------------------
\1\There are no capital costs or operating and maintenance costs associated with this collection of information.

FDA projects 30 emergency risk related surveys per year with a
sample of between 50 and 200 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 can analyze in a
timely manner. The annual frequency of response was determined by the
maximum number of questionnaires that will be sent to any individual
respondent. Some respondents may be contacted only one time per year,
while other respondents may be contacted several times annually,
depending on the human drug, biologic, or medical device under
evaluation. It is estimated that, given the expected type of issues
that will be addressed by the surveys, it will take 0.5 hours for a
respondent to gather the requested information and fill in the answers.

Dated: March 20, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6-4262 Filed 3-23-06; 8:45 am]
BILLING CODE 4160-01-S

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