Agency Information Collection Activities: Proposed Collection; Comment Request, 66438-66440 [05-21866]

Download as PDF 66438 Federal Register / Vol. 70, No. 211 / Wednesday, November 2, 2005 / Notices statement on the form so that it precedes the signature and date block. Second, OGE proposes modifying the Privacy Act Statement summary of the OGE Form 201. In 2003, OGE updated the OGE/GOVT–1 system of records notice (covering Executive Branch Personnel Public Financial Disclosure Reports and Other Name-Retrieved Ethics Program Records, and in which completed OGE Form 201s are maintained). See 68 FR 3097–3109, at 3100 (January 22, 2003). As a result, OGE is modifying the sixth routine use listed in the Privacy Act Statement summary in part II of the form. Finally, OGE proposes updating the edition date on pages one and two of the form. Reporting Burden OGE estimates that an average of 374 OGE Form 201s will be filed throughout the executive branch each year by members of the public (primarily by news media, public interest groups and private citizens) for the next three years. This figure is based on the number of OGE Form 201s filed at OGE by members of the public (221 for 2003 and 143 for 2004) and responses to OGE’s annual agency ethics program questionnaire (244 for 2003 and 140 for 2004) for a total of 748. That number is then divided by two to give the projected annual average of 374. The estimated average amount of time to complete the form, including review of the instructions, remains at ten minutes. Thus, the estimated annual public burden for the OGE Form 201 (throughout the executive branch) is 63 hours (374 form × 10 minutes per form ¥number rounded up). This is an increase from the current burden of 37 hours. The current burden accounts for filers whose OGE Form 201s were filed each year only with OGE. The proposed estimate of burden hours includes OGE Form 201s or equivalent access forms filed by the public with departments and agencies throughout the executive branch (including OGE). Web Site Distribution of Blank Forms The OGE Form 201 as modified will continue to be made available free-ofcharge as a downloadable and fillable Portable Document Format (PDF) file to the public as well as departments and agencies on OGE’s Internet Web site at http://www.usoge.gov. OGE will continue to permit departments and agencies to use the copy of the OGE Form 201 available on OGE’s Web site or to develop and utilize their own, electronic versions of the OGE form, provided that they precisely duplicate the original to the extent possible. Agencies can also develop VerDate Aug<31>2005 20:22 Nov 01, 2005 Jkt 208001 their own access forms, provided all the information required by the Ethics Act and OGE regulations is placed on such forms, along with the appropriate Privacy Act and paperwork notices with any attendant clearances being obtained by the agencies therefor. For now, OGE itself accepts filing of a completed OGE Form 201 by mail, fax, or in person, but does not permit E-mail or Internet online transmission. Similarly, requested copies of reports or other covered records are supplied by OGE as hard (paper) copies. Consideration of Comments Public comment is invited on each aspect of the proposed modified OGE Form 201 as set forth in this notice, including specifically views on the need for and practical utility of this information collection; the accuracy of OGE’s burden estimate; the enhancement of quality, utility and clarity of the information collected; and the minimization of burden (including the use of information technology). Comments received in response to this notice will be summarized for, and may be included with, the OGE request for OMB paperwork approval for this proposed modified information collection. The comments will also become a matter of public record. public health community, and other stakeholders. Contact Person for More Information: Substantive program information as well as summaries of meetings and a roster of Committee members may be obtained from Anna Poker, Lead Staff Person for the NCVHS Subcommittee on Special Populations, Working Group on Quality, Agency for Healthcare Research and Quality, Center for Quality Improvement and Patient Safety, 540 Gaither Road, Room #3331, Rockville, MD 20850, Phone: 301–427–1802; or Marjorie S. Greenberg, Executive Secretary, NCVHS, NCHS, CDC, 3311 Toledo Road, Hyattsville, Maryland 20782, telephone (301) 458–4245. Information also is available on the NCVHS home page of the HHS Web site: http://aspe.os.dhhs.gov/ncvhs, where an agenda for the meeting will be posted when available. Should you require reasonable accommodation, please contact the CDC Office of Equal Employment Opportunity on (301) 458–4EEO (4336) as soon as possible. Dated: October 20, 2005. James Scanlon, Deputy Assistant Secretary for Science and Data Policy, Office of the Assistant Secretary for Planning and Evaluation. [FR Doc. 05–21806 Filed 11–1–05; 8:45 am] Approved: October 27, 2005. Marilyn L. Glynn, General Counsel, Office of Government Ethics. [FR Doc. 05–21834 Filed 11–1–05; 8:45 am] BILLING CODE 4151–05–M BILLING CODE 6345–02–P Agency for Healthcare Research and Quality DEPARTMENT OF HEALTH AND HUMAN SERVICES Agency Information Collection Activities: Proposed Collection; Comment Request National Committee on Vital and Health Statistics: Meeting AGENCY: Pursuant to the Federal Advisory Committee Act, the Department of Health and Human Services announces the following advisory committee meeting: Name: National Committee on Vital and Health Statistics (NCVHS), Subcommittee on Populations— Working Group on Quality. Time and Date: 8:30 a.m.–5 p.m., November 18, 2005. Place: Hubert H. Humphrey Building, 200 Independence Avenue SW., Room 705A, Washington, DC 20201. Status: Open. Purpose: At this meeting the Working Group on Quality will study the expected impact of the electronic health record on health measurement and quality, hearing views from patients, the SUMMARY: This notice announces the intention of the Agency for Healthcare Research and Quality (AHRQ) to request that the Office of Management and Budget (OMB) allow the proposed information collection project: ‘‘Security Checkpoints and Patients With Radiopharmaceuticals.’’ In accordance with the Paperwork Reduction Act of 1995, 44 U.S.C. 3506(c)(2)(A), AHRQ invites the public to comment on this proposed information collection. DATES: Comments on this notice must be received by January 3, 2006. ADDRESSES: Written comments should be submitted to: Cynthia D. McMichael, Reports Clearance Officer, AHRQ, 540 Gaither Road, Suite 5022, Rockville, MD PO 00000 Frm 00092 Fmt 4703 Sfmt 4703 DEPARTMENT OF HEALTH AND HUMAN SERVICES Agency for Healthcare Research and Quality, HHS. ACTION: Notice. E:\FR\FM\02NON1.SGM 02NON1 66439 Federal Register / Vol. 70, No. 211 / Wednesday, November 2, 2005 / Notices 20850. Copies of the proposed collection plan, data collection instrument, and specific details on the estimated burden can be obtained from AHRQ’s Reports Clearance Officer. FOR FURTHER INFORMATION CONTACT: Cynthia D. McMichael, AHRQ, Reports Clearance Officer, (301) 427–1651. SUPPLEMENTARY INFORMATION: Proposed Project ‘‘Security Checkpoints and Patients With Radiopharmaceuticals’’ Patients receiving radioactive therapeutic or diagnostic compounds (called ‘‘radiopharmaceuticals’’) can emit radiation at the time when they are released from a hospital facility and present danger to their families and the public. In addition, these individuals might activate radiation detectors at airports, stadiums, and other public places, and will be stopped for questioning by law enforcement personnel. It is very important that hospitals provide patients with educational materials that explain the unique problems patients may face as a result of receiving this treatment, as well as provide guidance about how to respond to situations where law enforcement questions and other concerns may arise. The goal of the study is to determine what procedures are followed by hospitals when releasing patients treated with radioactive compounds. The study will involve interviewing 60 health care providers who are directly involved in the release of patients treated with radioactive compounds. Specifically, the interview protocol will be centered on the following topics: Methods of Collection (1) How health care providers determine when patients receiving radiopharmaceuticals can be released from care. (2) What type of information is provided to patients to ensure safety to their families and the public. (3) How this information is communicated to patients. (4) What information is (or can be) provided to patients who may activate radiation detectors at security checkpoints so that their processing is facilitated should questions regarding their medical procedures arise. Best practices identified through the analyses of interview data could lead to the development of standardized procedures to: (a) reduce secondary exposure to radiation by members of the patient’s family and by the public; and (b) ensure that patients who activate radiation detectors at security checkpoints understand why they emit radiation and carry the appropriate documentation to validate their statements. The study findings will be disseminated to the health care community through a scholarly publication journal article (title is to be determined). The date will be collected using a telephone survey. The contractor will contact each health care provider through appropriate management offices explaining this survey and ask to be directed to the appropriate, knowledgeable staff in their facility. The interviews will be conducted by telephone. If requested, the contractor will provide a copy of the interview questions in advance so that the hospital staff has time to obtain pertinent information. The contractor will also request copies of educational materials provided to patients, any specific tools used to calculate radiation dose to members of the public as well as other pertinent material. The contractor will obtain and evaluate the referenced educational materials qualitatively, describing the content and detail of such materials and reviewing them for clarity. In addition, the contractor will analyze the responses to the interview questions quantitatively and qualitatively as appropriate. To recruit the appropriate interviewees, we will first contact the Chief of Medicine’s office and ask the staff to refer us to the Head of the Department of Radiology/Radiation Oncology/Nuclear Medicine. (Based on our experience surveying health care providers, for smaller hospitals it is sometimes more effective to start with the Hospital Administrator’s office.) We will introduce ourselves, explain the goals of the study, and volunteer to provide a cover letter describing the study and any letters of endorsement. We will then contact the Department Heads and request that they refer us to the appropriate, knowledgeable staff in their departments. Data Confidentiality Provisions Data collected by the contractor and the contractor’s draft analyses will be retained for one year after final acceptance of all contract deliverables, unless, longer retention is requested by the agency for audit purposes. All agency documents pertaining to the contract will be archived after the contract is completed and retained in accordance with a Federal Records Act of 1950 retention schedule. ESTIMATED ANNUAL RESPONDENT BURDEN Number of respondents Type of survey Estimated time per respondent in minutes Estimated total burden hours Estimated annual cost to the respondents Telephone Interviews ....................................................................................... 60 45 45 $4500 Total .......................................................................................................... 60 45 45 4500 Request for Comments In accordance with the above cited legislation, comments on AHRQ’s information collection are requested with regard to any of the following: (a) Whether the proposed collection of information is necessary for the proper performance of functions of AHRQ, including whether the information will have practical utility; (b) the accuracy of VerDate Aug<31>2005 17:22 Nov 01, 2005 Jkt 208001 AHRQ’s estimate of burden (including hours and cost) of the proposed collection of information; (c) ways to enhance the quality, utility and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information upon the respondents, including the use of automated collection techniques or other forms of information technology. PO 00000 Frm 00093 Fmt 4703 Sfmt 4703 Comments submitted in response to this notice will be summarized and included in the request for OMB approval of the proposed information collection. All comments will become a matter of public record. E:\FR\FM\02NON1.SGM 02NON1 66440 Federal Register / Vol. 70, No. 211 / Wednesday, November 2, 2005 / Notices Dated: October 25, 2005. Carolyn M. Clancy, Director. [FR Doc. 05–21866 Filed 11–1–05; 8:45 am] DEPARTMENT OF HEALTH AND HUMAN SERVICES BILLING CODE 4160–90–M [Docket No. 2003N–0502] Food and Drug Administration Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Study to Measure the Compliance of Prescribers With the Contraindication of the Use of Triptans in Migraine Headache Patients With Vascular Disease DEPARTMENT OF HEALTH AND HUMAN SERVICES Administration on Aging 2005 White House Conference on Aging Administration on Aging, HHS. Notice of conference call. AGENCY: AGENCY: ACTION: HHS. Pursuant to section 10(a) of the Federal Advisory Committee Act as amended (5 U.S.C. Appendix 2), notice is hereby given that the Policy Committee of the 2005 White House Conference on Aging will vote on the Annotated Agenda for the WHCoA and may discuss other items related to finalizing the 2005 WHCoA during a conference call. The conference call will be open to the public to listen, with callins limited to the number of telephone lines available. Individuals who plan to call in and need special assistance, such as TTY, should inform the contact person listed below in advance of the conference call. This Notice is being published less than 15 days prior to the conference call due to scheduling problems. SUMMARY: The conference call will be held on Thursday, November 3, 2005, at 5 p.m., eastern standard time. ADDRESSES: The conference call may be accessed by dialing, U.S. toll-free, 1– 800–857–0419, passcode: 6045175, on the date and time indicated above. FOR FURTHER INFORMATION CONTACT: Kim Butcher, (301) 443–2887, or e-mail at Kim.Butcher@whcoa.gov. Registration is not required. Call in is on a first come, first-served basis. SUPPLEMENTARY INFORMATION: Pursuant to the Older Americans Act Amendments of 2000 (Pub. L. 106–501, November 2000), the Policy Committee will hold a meeting by conference call to vote on the Annotated Agenda for the 2005 White House Conference on Aging. The public is invited to listen by dialing the telephone number and using the passcode listed above under the Address section. DATES: Dated: October 28, 2005. Edwin L. Walker, Deputy Assistant Secretary for Policy and Programs. [FR Doc. 05–21823 Filed 11–1–05; 8:45 am] BILLING CODE 4154–01–P VerDate Aug<31>2005 17:22 Nov 01, 2005 Jkt 208001 ACTION: Food and Drug Administration, 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 December 2, 2005. 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: Karen L. Nelson, Office of Management Programs (HFA–250), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301–827–1482. 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. Study to Measure the Compliance of Prescribers With the Contraindication of the Use of Triptans in Migraine Headache Patients With Vascular Disease Migraine headache affects about 20 million Americans. Over the last decade, numerous drugs in a category referred to as ‘‘triptans’’ have been shown to be efficacious in treating migraine headache and have been approved for this condition. Triptan drugs have been prescribed to millions of patients. However, triptans are routinely contraindicated in patients with vascular diseases due to associated rare occurrence of myocardial PO 00000 Frm 00094 Fmt 4703 Sfmt 4703 infarction, stroke, and other ischemic events. In view of the wide use of this class of drugs and the potential impact on public health as a result of this contraindication, FDA believes it would be significantly helpful to better understand the prescribing practices for these drugs. FDA plans to examine the feasibility of using the Internet to recruit triptanuser migraine headache patients to determine whether prescribers follow the labeling recommendation by not prescribing this class of drugs to patients with pre-existing cardiovascular, cerebrovascular, or peripheral vascular syndromes or with cardiac risk factors. FDA intends to solicit patients over the Internet to identify a group of triptan users. FDA will then ask these patients to complete a questionnaire about their medical history with a focus on vascular diseases. Following that, FDA will request medical records from a sample of the patients and review the submitted records to verify the medical history and the presence, if any, of cardiovascular, cerebrovascular, or peripheral vascular ischemic diseases. FDA will also collect information about patients’ demographics, route of administration (oral, injection, intranasal), and duration of exposure to triptans. In the Federal Register of November 17, 2003 (68 FR 64902), FDA published a notice requesting comment on this information collection. Three comments were received in response to the notice, each raising several issues, as follows: (1) One comment contended that the agency has not put forth an adequate foundation for conducting the study. The comment said that no data or other information has been described to justify the expenditure of government resources and the imposition of information collection burdens on the industry. The comment said that the only rationale consists of speculation that ‘‘it would be of great use to better understand the prescribing practices as a result of this contraindication [use of triptans in patients with vascular diseases].’’ The comment contended that this is an insufficient predicate for conducting publicly-funded research that casts a cloud of suspicion over a class of currently marketed drug products that provide great clinical benefit to patients who suffer from migraine headaches. The comment said that the Federal Register notice provides no information about FDA’s view of the relative role of data derived from the survey in relation to data from controlled clinical studies, epidemiology studies, and spontaneous medical event reports. E:\FR\FM\02NON1.SGM 02NON1

Agencies

[Federal Register Volume 70, Number 211 (Wednesday, November 2, 2005)]
[Notices]
[Pages 66438-66440]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-21866]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Agency for Healthcare Research and Quality


Agency Information Collection Activities: Proposed Collection; 
Comment Request

AGENCY: Agency for Healthcare Research and Quality, HHS.

ACTION: Notice.

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

SUMMARY: This notice announces the intention of the Agency for 
Healthcare Research and Quality (AHRQ) to request that the Office of 
Management and Budget (OMB) allow the proposed information collection 
project: ``Security Checkpoints and Patients With 
Radiopharmaceuticals.'' In accordance with the Paperwork Reduction Act 
of 1995, 44 U.S.C. 3506(c)(2)(A), AHRQ invites the public to comment on 
this proposed information collection.

DATES: Comments on this notice must be received by January 3, 2006.

ADDRESSES: Written comments should be submitted to: Cynthia D. 
McMichael, Reports Clearance Officer, AHRQ, 540 Gaither Road, Suite 
5022, Rockville, MD

[[Page 66439]]

20850. Copies of the proposed collection plan, data collection 
instrument, and specific details on the estimated burden can be 
obtained from AHRQ's Reports Clearance Officer.

FOR FURTHER INFORMATION CONTACT: Cynthia D. McMichael, AHRQ, Reports 
Clearance Officer, (301) 427-1651.

SUPPLEMENTARY INFORMATION:

Proposed Project

``Security Checkpoints and Patients With Radiopharmaceuticals''

    Patients receiving radioactive therapeutic or diagnostic compounds 
(called ``radiopharmaceuticals'') can emit radiation at the time when 
they are released from a hospital facility and present danger to their 
families and the public. In addition, these individuals might activate 
radiation detectors at airports, stadiums, and other public places, and 
will be stopped for questioning by law enforcement personnel. It is 
very important that hospitals provide patients with educational 
materials that explain the unique problems patients may face as a 
result of receiving this treatment, as well as provide guidance about 
how to respond to situations where law enforcement questions and other 
concerns may arise.
    The goal of the study is to determine what procedures are followed 
by hospitals when releasing patients treated with radioactive 
compounds.
    The study will involve interviewing 60 health care providers who 
are directly involved in the release of patients treated with 
radioactive compounds.
    Specifically, the interview protocol will be centered on the 
following topics:
    (1) How health care providers determine when patients receiving 
radiopharmaceuticals can be released from care.
    (2) What type of information is provided to patients to ensure 
safety to their families and the public.
    (3) How this information is communicated to patients.
    (4) What information is (or can be) provided to patients who may 
activate radiation detectors at security checkpoints so that their 
processing is facilitated should questions regarding their medical 
procedures arise.
    Best practices identified through the analyses of interview data 
could lead to the development of standardized procedures to: (a) reduce 
secondary exposure to radiation by members of the patient's family and 
by the public; and (b) ensure that patients who activate radiation 
detectors at security checkpoints understand why they emit radiation 
and carry the appropriate documentation to validate their statements. 
The study findings will be disseminated to the health care community 
through a scholarly publication journal article (title is to be 
determined).

Data Confidentiality Provisions

    Data collected by the contractor and the contractor's draft 
analyses will be retained for one year after final acceptance of all 
contract deliverables, unless, longer retention is requested by the 
agency for audit purposes.
    All agency documents pertaining to the contract will be archived 
after the contract is completed and retained in accordance with a 
Federal Records Act of 1950 retention schedule.

Methods of Collection

    The date will be collected using a telephone survey. The contractor 
will contact each health care provider through appropriate management 
offices explaining this survey and ask to be directed to the 
appropriate, knowledgeable staff in their facility. The interviews will 
be conducted by telephone. If requested, the contractor will provide a 
copy of the interview questions in advance so that the hospital staff 
has time to obtain pertinent information. The contractor will also 
request copies of educational materials provided to patients, any 
specific tools used to calculate radiation dose to members of the 
public as well as other pertinent material. The contractor will obtain 
and evaluate the referenced educational materials qualitatively, 
describing the content and detail of such materials and reviewing them 
for clarity. In addition, the contractor will analyze the responses to 
the interview questions quantitatively and qualitatively as 
appropriate.
    To recruit the appropriate interviewees, we will first contact the 
Chief of Medicine's office and ask the staff to refer us to the Head of 
the Department of Radiology/Radiation Oncology/Nuclear Medicine. (Based 
on our experience surveying health care providers, for smaller 
hospitals it is sometimes more effective to start with the Hospital 
Administrator's office.) We will introduce ourselves, explain the goals 
of the study, and volunteer to provide a cover letter describing the 
study and any letters of endorsement. We will then contact the 
Department Heads and request that they refer us to the appropriate, 
knowledgeable staff in their departments.

                                       Estimated Annual Respondent Burden
----------------------------------------------------------------------------------------------------------------
                                                                                                     Estimated
                                                     Number of    Estimated time     Estimated    annual cost to
                 Type of survey                     respondents   per respondent   total burden         the
                                                                    in minutes         hours        respondents
----------------------------------------------------------------------------------------------------------------
Telephone Interviews............................              60              45              45           $4500
                                                 -----------------
    Total.......................................              60              45              45            4500
----------------------------------------------------------------------------------------------------------------

Request for Comments

    In accordance with the above cited legislation, comments on AHRQ's 
information collection are requested with regard to any of the 
following: (a) Whether the proposed collection of information is 
necessary for the proper performance of functions of AHRQ, including 
whether the information will have practical utility; (b) the accuracy 
of AHRQ's estimate of burden (including hours and cost) of the proposed 
collection of information; (c) ways to enhance the quality, utility and 
clarity of the information to be collected; and (d) ways to minimize 
the burden of the collection of information upon the respondents, 
including the use of automated collection techniques or other forms of 
information technology.
    Comments submitted in response to this notice will be summarized 
and included in the request for OMB approval of the proposed 
information collection. All comments will become a matter of public 
record.


[[Page 66440]]


    Dated: October 25, 2005.
Carolyn M. Clancy,
Director.
[FR Doc. 05-21866 Filed 11-1-05; 8:45 am]
BILLING CODE 4160-90-M