Proposed Collection; Comment Request; REDS-II-Does Pre-Donation Behavioral Deferral Increase the Safety of the Blood Supply?, 8367-8368 [2010-3754]

Download as PDF 8367 Federal Register / Vol. 75, No. 36 / Wednesday, February 24, 2010 / Notices ESTIMATE OF ANNUALIZED BURDEN HOURS Type of respondent Form A 83.9 ...... Form B 83.9 ...... Form B 83.9 ...... Petitioner using Form A .................................................... Petitioner using Form B .................................................... Petitioner submission format other than Form B (as permitted by rule). Petitioner Appealing final HHS decision (no specific form is required). Claimant authorizing a party to submit petition on his/her behalf. 83.18 ................. Total ........... ........................................................................................... Dated: February 18, 2010. Maryam I. Daneshvar, Acting Reports Clearance Officer, Centers for Disease Control and Prevention. [FR Doc. 2010–3702 Filed 2–23–10; 8:45 am] BILLING CODE 4163–18–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health pwalker on DSK8KYBLC1PROD with NOTICES Proposed Collection; Comment Request; REDS—II—Does PreDonation Behavioral Deferral Increase the Safety of the Blood Supply? SUMMARY: In compliance with the requirement of Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, for opportunity for public comment on proposed data collection projects, the National Heart, Lung, and Blood Institute (NHLBI), the National Institutes of Health (NIH), will publish periodic summaries of proposed projects to the Office of Management and Budget (OMB) for review and approval. Proposed Collection: Title: REDS–II Does Pre-Donation Behavioral Deferral Increase the Safety of the Blood Supply? Type of Information Collection Request: NEW. Need and Use of Information Collection: While it is wellaccepted that deferrals, as part of the ‘‘layers of safety’’ concept, increase the safety of the blood supply, studies with sufficiently large sample size to quantify HIV infection and other infectious marker rates in deferred donors are lacking. Evidence in support of increased safety is frequently inferred from studies conducted in other health care settings. For example, a small hospital-based case control study conducted in Brazil examined the association between infectious markers and body tattoos. Even though tattoos are not used as a criteria to determine VerDate Nov<24>2008 16:49 Feb 23, 2010 Jkt 220001 No. of responses per respondent No. of respondents Form name Frm 00074 Fmt 4703 Sfmt 4703 Total response burden hours 30 40 5 1 1 1 3/60 5 6 2 200 30 5 1 45/60 4 20 1 3/60 1 100 ........................ ........................ 237 blood donor eligibility in Brazil, having a tattoo was associated with HCV and also with having at least one positive infectious marker. (1) Significant associations were not independently observed for HIV, HBV, syphilis or Chagas. The authors reported an overall sensitivity of 11% and specificity of 97% for the presence of a tattoo as indicator of having HIV, HCV, HBV, or syphilis infection. The researchers then estimated the impact on blood donor selection and disease marker testing using the results from their hospitalbased case control study. However, the assumptions such as disease marker prevalence of as much as 15% in donors who are deferred for tattoos and a prevalence of 4% of the potential donor base having a tattoo (2) do not represent current temporary deferrals in Brazil and do not address the most common behavior-related deferrals. A more detailed and targeted assessment of the value of relevant deferrals could be used to help inform blood donation policies in Brazil. In Brazilian blood collection centers, donor deferral is initiated either by the blood center staff, based on information disclosed by prospective donors, or by the donor through self-deferral. Either type of deferral occurs because of the belief that a donor’s behavior, exposures, or history represents an increased risk to the safety of the blood supply Although the general eligibility criteria are mandated by the Brazilian Ministry of Health, the specific criteria for screening potential donors and the procedures for implementing them may vary across the regional blood collection centers. This study will focus on sexual behavior deferrals and their impact on blood safety. The two main study aims are: (1) To assess infectious disease marker prevalence in donors who are deferred for higher risk sexual and noninjection drug use behavior; and (2) To PO 00000 Average burden per respondent (in hours) determine if the different deferral classification procedures used by different blood centers in Brazil lead to a measurable difference in disease marker prevalence in deferred donors. To do this, deferred donors who agree to participate in this study will be asked to complete an audio computer assisted self interview (ACASI) questionnaire that measures two content areas (1) motivations for attempting to donate, (2) additional information on the deferral and other potentially undisclosed deferrable behaviors. A blood sample will be collected from the deferred donors and tested for the panel of infections currently screened for in Brazil (HIV, Hepatitis C, Hepatitis B, Human T-lymphotropic virus, syphilis, and Trypanosoma cruzi) using the same high-throughput laboratory reagents and procedures that are used to screen donations. These deferred donor marker rates will be compared to the marker rates among accepted donors with the same demographic characteristics. Marker rates in deferred donors will also be compared between the blood centers. Frequency of Response: Once. Affected Public: Individuals. Type of Respondents: Adult Blood Donors. The annual reporting burden is as follows: Estimated Number of Respondents: 4,860; Estimated Number of Responses per Respondent: 1; Average Burden of Hours per Response: 0.33 (including administration of the informed consent form and questionnaire completion instructions); and Estimated Total Annual Burden Hours Requested: 1,620. The annualized cost to respondents is estimated at: $10,530 (based on $6.50 per hour). There are no Capital Costs to report. There are no Operating or Maintenance Costs to report. E:\FR\FM\24FEN1.SGM 24FEN1 8368 Federal Register / Vol. 75, No. 36 / Wednesday, February 24, 2010 / Notices Estimated number of responses per respondent Estimated number of respondents Average burden hours per response Estimated total annual burden hours requested 1 0.33 1,620 4,860 ................................................................................................................................ Request for Comments: Written comments and/or suggestions from the public and affected agencies should address one or more of the following points: (1) Evaluate whether the proposed collection of information is necessary for the proper performance of the function of the agency, including whether the information will have practical utility; (2) Evaluate the accuracy of the agency’s estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) Enhance the quality, utility, and clarity of the information to be collected; and (4) Minimize the burden of the collection of information on those who are to respond, including the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology. FOR FURTHER INFORMATION CONTACT: To request more information on the proposed project or to obtain a copy of the data collection plans and instruments, contact Dr. George Nemo, Project Officer, NHLBI, Two Rockledge Center, Suite 10042, 6701 Rockledge Drive, Bethesda, MD 20892–7950, or call 301–435–0075, or E-mail your request to nemog@nih.gov. Comments Due Date: Comments regarding this information collection are best assured of having their full effect if received within 60 days of the date of this publication. Dated: February 17, 2010. Dr. George Nemo, NHLBI Project Officer, NHLBI, National Institutes of Health. [FR Doc. 2010–3754 Filed 2–23–10; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration pwalker on DSK8KYBLC1PROD with NOTICES [Docket No. FDA–2010–N–0067] Advisory Committee for Pharmaceutical Science and Clinical Pharmacology; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. VerDate Nov<24>2008 16:49 Feb 23, 2010 Jkt 220001 This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration (FDA). The meeting will be open to the public. Name of Committee: Advisory Committee for Pharmaceutical Science and Clinical Pharmacology. General Function of the Committee: To provide advice and recommendations to the agency on FDA’s regulatory issues. Date and Time: The meeting will be held on March 17, 2010, from 7:30 a.m. to 3 p.m. Location: Atlanta Marriott Marquis, 265 Peachtree Center Ave., Atlanta, GA 30303. The hotel phone number is 404– 521–0000. Addresses: Submit electronic comments on this document to https:// www.regulations.gov. Submit written comments to the Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit a single copy of electronic comments or two paper copies of any mailed comments, except that individuals may submit one paper copy. Comments should be identified with the docket number found in brackets in the heading of this document. Comments received on or before March 8, 2010, will be provided to the committee before the meeting. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. Contact Person: Yvette Waples, Center for Drug Evaluation and Research (HFD– 21), Food and Drug Administration, 5600 Fishers Lane (for express delivery, 5630 Fishers Lane, rm. 1093), Rockville, MD 20857, 301–827–7001, FAX: 301– 827–6776, e-mail: yvette.waples@fda.hhs.gov, or FDA Advisory Committee Information Line, 1–800–741–8138 (301–443–0572 in the Washington, DC area), code 3014512539. Please call the Information Line for up-to-date information on this meeting. A notice in the Federal Register about last minute modifications that impact a previously announced advisory committee meeting cannot always be published quickly enough to provide timely notice. Therefore, you should always check the agency’s Web site and call the appropriate advisory PO 00000 Frm 00075 Fmt 4703 Sfmt 4703 committee hot line/phone line to learn about possible modifications before coming to the meeting. Agenda: On March 17, 2010, the committee will discuss and provide comments on the following topics: (1) General scientific issues related to the application of pharmacogenomics in the early stages of drug development. Pharmacogenomics examines the genetic differences that influence a person’s responses, both beneficial and harmful, to certain drugs; (2) a new patient-centric clinical pharmacology approach to drug safety; (3) the design and analysis of clinical pharmacology studies focusing on how the renal function changes in the way the body absorbs, distributes, metabolizes, and excretes a drug in patients with kidney impairment; and (4) scientific considerations and recent developments in transporter-mediated drug interactions. These interactions are between two or more drugs that either inhibit or enhance the roles of specialized proteins known as ‘‘transporters’’ and, in turn, the interactions can affect a drug’s safety and/or efficacy. FDA intends to make background material available to the public no later than 2 business days before the meeting. If FDA is unable to post the background material on its Web site prior to the meeting, the background material will be made publicly available at the location of the advisory committee meeting, and the background material will be posted on FDA’s Web site after the meeting. Background material is available at https://www.fda.gov/ AdvisoryCommittees/Calendar/ default.htm. Scroll down to the appropriate advisory committee link. Procedure: Interested persons may present data, information, or views, orally or in writing, on issues pending before the committee. Written submissions may be made to the contact person on or before March 8, 2010. Oral presentations from the public will be scheduled between approximately 9:25 a.m. and 10 a.m., and 1:15 p.m. and 1:45 p.m. Those desiring to make formal oral presentations should notify the contact person and submit a brief statement of the general nature of the evidence or arguments they wish to present, the names and addresses of proposed E:\FR\FM\24FEN1.SGM 24FEN1

Agencies

[Federal Register Volume 75, Number 36 (Wednesday, February 24, 2010)]
[Notices]
[Pages 8367-8368]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-3754]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Proposed Collection; Comment Request; REDS--II--Does Pre-Donation 
Behavioral Deferral Increase the Safety of the Blood Supply?

SUMMARY: In compliance with the requirement of Section 3506(c)(2)(A) of 
the Paperwork Reduction Act of 1995, for opportunity for public comment 
on proposed data collection projects, the National Heart, Lung, and 
Blood Institute (NHLBI), the National Institutes of Health (NIH), will 
publish periodic summaries of proposed projects to the Office of 
Management and Budget (OMB) for review and approval.
    Proposed Collection: Title: REDS-II Does Pre-Donation Behavioral 
Deferral Increase the Safety of the Blood Supply?
    Type of Information Collection Request: NEW. Need and Use of 
Information Collection: While it is well-accepted that deferrals, as 
part of the ``layers of safety'' concept, increase the safety of the 
blood supply, studies with sufficiently large sample size to quantify 
HIV infection and other infectious marker rates in deferred donors are 
lacking. Evidence in support of increased safety is frequently inferred 
from studies conducted in other health care settings. For example, a 
small hospital-based case control study conducted in Brazil examined 
the association between infectious markers and body tattoos. Even 
though tattoos are not used as a criteria to determine blood donor 
eligibility in Brazil, having a tattoo was associated with HCV and also 
with having at least one positive infectious marker. (1) Significant 
associations were not independently observed for HIV, HBV, syphilis or 
Chagas. The authors reported an overall sensitivity of 11% and 
specificity of 97% for the presence of a tattoo as indicator of having 
HIV, HCV, HBV, or syphilis infection. The researchers then estimated 
the impact on blood donor selection and disease marker testing using 
the results from their hospital-based case control study. However, the 
assumptions such as disease marker prevalence of as much as 15% in 
donors who are deferred for tattoos and a prevalence of 4% of the 
potential donor base having a tattoo (2) do not represent current 
temporary deferrals in Brazil and do not address the most common 
behavior-related deferrals. A more detailed and targeted assessment of 
the value of relevant deferrals could be used to help inform blood 
donation policies in Brazil.
    In Brazilian blood collection centers, donor deferral is initiated 
either by the blood center staff, based on information disclosed by 
prospective donors, or by the donor through self-deferral. Either type 
of deferral occurs because of the belief that a donor's behavior, 
exposures, or history represents an increased risk to the safety of the 
blood supply
    Although the general eligibility criteria are mandated by the 
Brazilian Ministry of Health, the specific criteria for screening 
potential donors and the procedures for implementing them may vary 
across the regional blood collection centers. This study will focus on 
sexual behavior deferrals and their impact on blood safety. The two 
main study aims are: (1) To assess infectious disease marker prevalence 
in donors who are deferred for higher risk sexual and non-injection 
drug use behavior; and (2) To determine if the different deferral 
classification procedures used by different blood centers in Brazil 
lead to a measurable difference in disease marker prevalence in 
deferred donors. To do this, deferred donors who agree to participate 
in this study will be asked to complete an audio computer assisted self 
interview (ACASI) questionnaire that measures two content areas (1) 
motivations for attempting to donate, (2) additional information on the 
deferral and other potentially undisclosed deferrable behaviors. A 
blood sample will be collected from the deferred donors and tested for 
the panel of infections currently screened for in Brazil (HIV, 
Hepatitis C, Hepatitis B, Human T-lymphotropic virus, syphilis, and 
Trypanosoma cruzi) using the same high-throughput laboratory reagents 
and procedures that are used to screen donations. These deferred donor 
marker rates will be compared to the marker rates among accepted donors 
with the same demographic characteristics. Marker rates in deferred 
donors will also be compared between the blood centers.
    Frequency of Response: Once. Affected Public: Individuals. Type of 
Respondents: Adult Blood Donors. The annual reporting burden is as 
follows: Estimated Number of Respondents: 4,860; Estimated Number of 
Responses per Respondent: 1; Average Burden of Hours per Response: 0.33 
(including administration of the informed consent form and 
questionnaire completion instructions); and Estimated Total Annual 
Burden Hours Requested: 1,620. The annualized cost to respondents is 
estimated at: $10,530 (based on $6.50 per hour). There are no Capital 
Costs to report. There are no Operating or Maintenance Costs to report.

[[Page 8368]]



 
----------------------------------------------------------------------------------------------------------------
                                                            Estimated number   Average burden    Estimated total
              Estimated number of respondents               of responses per      hours per       annual burden
                                                               respondent         response       hours requested
----------------------------------------------------------------------------------------------------------------
4,860.....................................................                 1              0.33             1,620
----------------------------------------------------------------------------------------------------------------

    Request for Comments: Written comments and/or suggestions from the 
public and affected agencies should address one or more of the 
following points: (1) Evaluate whether the proposed collection of 
information is necessary for the proper performance of the function of 
the agency, including whether the information will have practical 
utility; (2) Evaluate the accuracy of the agency's estimate of the 
burden of the proposed collection of information, including the 
validity of the methodology and assumptions used; (3) Enhance the 
quality, utility, and clarity of the information to be collected; and 
(4) Minimize the burden of the collection of information on those who 
are to respond, including the use of appropriate automated, electronic, 
mechanical, or other technological collection techniques or other forms 
of information technology.

FOR FURTHER INFORMATION CONTACT: To request more information on the 
proposed project or to obtain a copy of the data collection plans and 
instruments, contact Dr. George Nemo, Project Officer, NHLBI, Two 
Rockledge Center, Suite 10042, 6701 Rockledge Drive, Bethesda, MD 
20892-7950, or call 301-435-0075, or E-mail your request to 
nemog@nih.gov.
    Comments Due Date: Comments regarding this information collection 
are best assured of having their full effect if received within 60 days 
of the date of this publication.

    Dated: February 17, 2010.
Dr. George Nemo,
NHLBI Project Officer, NHLBI, National Institutes of Health.
[FR Doc. 2010-3754 Filed 2-23-10; 8:45 am]
BILLING CODE 4140-01-P

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