80 FR 18853 - Proposed Collection; 60-Day Comment Request
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health Federal Register Volume 80, Issue 67 (April 8, 2015)
National Institutes of Health
Federal Register Volume 80, Issue 67 (April 8, 2015)
| Page Range | 18853-18854 | |
| FR Document | 2015-07980 |
[Federal Register Volume 80, Number 67 (Wednesday, April 8, 2015)] [Notices] [Pages 18853-18854] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-07980] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Proposed Collection; 60-Day Comment Request The effectiveness of donor notification, HIV counseling, and linkage of HIV positive donors to health care in Brazil (NHLBI). 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. Written comments and/or suggestions from the public and affected agencies are invited on one or more of the following points: (1) 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) 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) 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 those who are to respond, including the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology. To Submit Comments and For Further Information: To obtain a copy of the data collection plans and instruments, submit comments in writing, or request more information on the proposed project, contact: Simone Glynn, MD, Project Officer/ICD Contact, Two Rockledge Center, Suite 9142, 6701 Rockledge Drive, Bethesda, MD 20892, or call 301-435-0065, or Email your request, including your address to: [email protected]. Formal requests for additional plans and instruments must be requested in writing. DATES: Comment 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. Proposed Collection: The effectiveness of donor notification, HIV counseling, and linkage of HIV positive donors to health care in Brazil (The Brazil Notification Study), 0925-New, National Heart, Lung and Blood Institute (NHLBI). Need and Use of Information Collection: The prevention of transfusion-associated transmission of HIV is one of the greatest success stories in the fight against the HIV epidemic; however, the job is unfinished. In some middle-and low-income countries, blood transfusion may account for up to 6% of HIV infections (1). Currently, all blood donors who test positive or inconclusive for HIV or other sexually transmitted diseases are notified (donor notification) and requested to follow-up with the blood bank for potential confirmatory testing and referral to specific health services, such as monitoring and treatment. Little is known about the consequences of blood donor notification and subsequent monitoring and counseling on efforts to control the HIV epidemic in the United States and internationally. The Brazil Notification Study team proposed to addresses this significant information gap by enrolling all former blood donors who participated in the REDS-II HIV case-control study (OMB 0925-0597, expired on February 29, 2012) and those enrolled during the REDS-III HIV case surveillance risk factor study (OMB 0925-0597, expiration date, July 31, 2015), between 2012 and 2014. Donor enrollees at any of the four blood centers participating in these studies completed an audio computer-assisted structured interview (ACASI) that elicited responses on demographics, risk factors/behaviors, and HIV knowledge. At the same time, a blood sample was drawn and tested for HIV genotype and drug resistance. In addition, recent infection status was determined using detuned antibody testing of samples from the original blood donation. All enrolled participants received counseling by a blood bank physician and were referred to HIV counseling and testing centers (HCT). New information gathered from these enrollees will serve the three aims proposed for this proposed study. The first aim of this study will be to analyze the actual percentage of blood donors who are successfully notified of their infection testing results. In this aim, we will expand the notification focus to include all infections that blood centers in Brazil test for because differences in rates of notification by type of infection are unknown. The second aim will assess the effectiveness of HIV notification and counseling. HIV- positive donors will be interviewed to evaluate their follow-up activities with regard to HIV infection treatment and infection transmission prevention [[Page 18854]] behavior after notification by the blood center. This will be accomplished using a new audio computer-assisted structured interview (ACASI) (See Attachment 1, Brazil HIV Follow up ACASI Survey). The third aim will consist of asking HIV-positive blood donors about ways to improve the disclosure of HIV risks during donor eligibility assessment to better understand the motivating factors that drive higher risk persons to donate blood. Because our study will build off the routine blood donor procedures in four large blood banks in Brazil, it may lead to more informed conversations around and possible changes in donor screening, notification and counseling policies in Latin America. Results of these three aims may also help to better integrate blood centers within the context of broader HIV testing, counseling and treatment sites in Brazil. Similarly, in the US little is known about donor behavior after notification of testing results by blood centers. The results from this study can be used to develop insights and hypotheses focused on developing improved strategies for notification and counseling of HIV- positive (or hepatitis C or B-positive) donors in the U.S. This proposed study's findings will also yield insights into improved methods for donor self-selection and qualification post donation, which will serve to decrease the frequency of higher-risk persons acting as donors. Our findings on improved methods for Brazilian donor notification and linkage to health care services may also be applicable to developed countries, including the U.S. Results of the Brazil Notification Study will identify how to improve notification and counseling strategies that increase the number of HIV- positive donors seeking prompt medical care. This might ultimately boost strategies to prevent secondary HIV transmission and reduce the risk of transfusion-transmission. In addition to the traditional route of scientific dissemination through peer reviewed scientific publication, previous REDS and REDS-II study data were the subject of numerous requested presentations by Federal and non-Federal agencies, including the FDA Blood Products Advisory Committee, the HHS Advisory committee on Blood Safety and Availability, the AABB Transfusion-Transmitted Diseases Committee, and the Americas Blood Centers (ABC). We anticipate similar requests for results generated from this study. Data collected in this proposed HIV Notification study of donors will be of practical use to the blood banking and infectious disease communities in the U.S. and internationally. OMB approval is requested for 3 years. There are no costs to respondents other than their time. The total estimated annualized burden hours are 229. Estimated Annualized Burden Hours -------------------------------------------------------------------------------------------------------------------------------------------------------- Estimated Number of Number of Average burden total annual Form name Type of respondent respondents responses per per response burden hours respondent requested -------------------------------------------------------------------------------------------------------------------------------------------------------- ACASI Questionnaire--Informed Consent....... Adults.................................... 275 1 10/60 46 ACASI Questionnaire......................... Adults.................................... 275 1 40/60 183 -------------------------------------------------------------------------------------------------------------------------------------------------------- Dated: April 2, 2015. Lynn Susulske, NHLBI Project Clearance Liaison, National Institutes of Health. [FR Doc. 2015-07980 Filed 4-7-15; 8:45 am] BILLING CODE 4140-01-P
![Federal Register / Vol. 80, No. 67 / Wednesday, April 8, 2015 / Notices 18853
legitimate biological research that generates DEPARTMENT OF HEALTH AND Brazil Notification Study), 0925–New,
information and technologies that could be HUMAN SERVICES National Heart, Lung and Blood
misused to pose a biological threat to public Institute (NHLBI).
health and/or national security. National Institutes of Health Need and Use of Information
The meeting will be open to the public and
Collection: The prevention of
will also be webcast as space will be limited. Proposed Collection; 60-Day Comment
Persons planning to attend or view via the transfusion-associated transmission of
webcast may pre-register online using the
Request HIV is one of the greatest success stories
link provided below or by calling Palladian The effectiveness of donor in the fight against the HIV epidemic;
Partners, Inc. (Contact: Monica Barnette at notification, HIV counseling, and however, the job is unfinished. In some
301–650–8660). Online and telephone
linkage of HIV positive donors to health middle-and low-income countries,
registration will close at 12:00 p.m. Eastern blood transfusion may account for up to
on May 4, 2015. After that time, attendees care in Brazil (NHLBI).
6% of HIV infections (1). Currently, all
may register onsite on the day of the meeting. SUMMARY: In compliance with the
blood donors who test positive or
Individuals who plan to attend and need requirement of Section 3506(c) (2) (A) of
special assistance, such as sign language
inconclusive for HIV or other sexually
the Paperwork Reduction Act of 1995,
interpretation or other reasonable transmitted diseases are notified (donor
for opportunity for public comment on
accommodations, should indicate these notification) and requested to follow-up
proposed data collection projects, the with the blood bank for potential
requirements upon registration.
National Heart, Lung, and Blood confirmatory testing and referral to
Please Note: The meeting agenda, proposed
draft framework, and links to the online Institute (NHLBI), the National specific health services, such as
registration and webcast will be available at: Institutes of Health (NIH), will publish monitoring and treatment. Little is
http://osp.od.nih.gov/office-biotechnology- periodic summaries of proposed known about the consequences of blood
activities/biosecurity/nsabb/nsabb-meetings- projects to the Office of Management donor notification and subsequent
and-conferences. Please check this Web site and Budget (OMB) for review and monitoring and counseling on efforts to
for updates. approval.
Public Comments: Time will be allotted on control the HIV epidemic in the United
Written comments and/or suggestions States and internationally. The Brazil
the agenda for oral public comment, with from the public and affected agencies
individual presentations time-limited to Notification Study team proposed to
are invited on one or more of the addresses this significant information
facilitate broad input from multiple speakers.
Any member of the public interested in following points: (1) Whether the gap by enrolling all former blood donors
presenting comments relevant to the mission proposed collection of information is who participated in the REDS–II HIV
of the NSABB should indicate so upon necessary for the proper performance of case-control study (OMB 0925–0597,
registration. Sign-ups for oral comments will the function of the agency, including expired on February 29, 2012) and those
be restricted to one per person or whether the information will have
organization representative per comment
enrolled during the REDS–III HIV case
practical utility; (2) The accuracy of the surveillance risk factor study (OMB
period. In the event that time does not allow agency’s estimate of the burden of the
for all attendees interested in presenting oral 0925–0597, expiration date, July 31,
proposed collection of information, 2015), between 2012 and 2014. Donor
comments to do so at the meeting, any
interested person may file written comments including the validity of the enrollees at any of the four blood
with the Board via an email sent to nsabb@ methodology and assumptions used; (3) centers participating in these studies
od.nih.gov or by regular mail sent to the Ways to enhance the quality, utility, and completed an audio computer-assisted
Contact Person listed on this notice. In clarity of the information to be structured interview (ACASI) that
addition, any interested person may submit collected; and (4) Ways to minimize the elicited responses on demographics, risk
written comments to the NSABB at any time burden of the collection of information
via either of these methods. Comments
factors/behaviors, and HIV knowledge.
on those who are to respond, including At the same time, a blood sample was
received by 5:00 p.m. Eastern on April 28,
the use of appropriate automated, drawn and tested for HIV genotype and
2015 will be relayed to the Board prior to the
NSABB meeting. Written statements should electronic, mechanical, or other drug resistance. In addition, recent
include the name, address, telephone number technological collection techniques or infection status was determined using
and when applicable, the professional other forms of information technology. detuned antibody testing of samples
affiliation of the interested person. Any To Submit Comments and For Further from the original blood donation. All
written comments received after the deadline Information: To obtain a copy of the enrolled participants received
will be provided to the Board either before data collection plans and instruments, counseling by a blood bank physician
or after the meeting, depending on the submit comments in writing, or request
volume of comments received and the time
and were referred to HIV counseling and
more information on the proposed testing centers (HCT).
required to process them in accordance with project, contact: Simone Glynn, MD,
privacy regulations and other applicable New information gathered from these
Federal policies.
Project Officer/ICD Contact, Two enrollees will serve the three aims
Please Note: In the interest of security, NIH Rockledge Center, Suite 9142, 6701 proposed for this proposed study. The
has instituted stringent procedures for Rockledge Drive, Bethesda, MD 20892, first aim of this study will be to analyze
entrance onto the NIH campus. All visitor or call 301–435–0065, or Email your the actual percentage of blood donors
vehicles, including taxis, hotel, and airport request, including your address to: who are successfully notified of their
shuttles will be inspected before being glynnsa@nhlbi.nih.gov. Formal requests infection testing results. In this aim, we
allowed on campus. Visitors will be asked to for additional plans and instruments will expand the notification focus to
show one form of identification (for example, must be requested in writing. include all infections that blood centers
a government-issued photo ID, driver’s
DATES: Comment Due Date: Comments in Brazil test for because differences in
asabaliauskas on DSK5VPTVN1PROD with NOTICES
license, or passport) and to state the purpose
of their visit. regarding this information collection are rates of notification by type of infection
best assured of having their full effect if are unknown. The second aim will
Dated: April 2, 2015. received within 60 days of the date of assess the effectiveness of HIV
David Clary, this publication. notification and counseling. HIV-
Program Analyst, Office of Federal Advisory Proposed Collection: The positive donors will be interviewed to
Committee Policy. effectiveness of donor notification, HIV evaluate their follow-up activities with
[FR Doc. 2015–07981 Filed 4–7–15; 8:45 am] counseling, and linkage of HIV positive regard to HIV infection treatment and
BILLING CODE 4140–01–P donors to health care in Brazil (The infection transmission prevention
VerDate Sep<11>2014 17:55 Apr 07, 2015 Jkt 235001 PO 00000 Frm 00048 Fmt 4703 Sfmt 4703 E:\FR\FM\08APN1.SGM 08APN1](https://thefederalregister.org/doc/80_FR_18920/page/1.svg)
![18854 Federal Register / Vol. 80, No. 67 / Wednesday, April 8, 2015 / Notices
behavior after notification by the blood of testing results by blood centers. The In addition to the traditional route of
center. This will be accomplished using results from this study can be used to scientific dissemination through peer
a new audio computer-assisted develop insights and hypotheses reviewed scientific publication,
structured interview (ACASI) (See focused on developing improved previous REDS and REDS–II study data
Attachment 1, Brazil HIV Follow up strategies for notification and were the subject of numerous requested
ACASI Survey). The third aim will counseling of HIV-positive (or hepatitis presentations by Federal and non-
consist of asking HIV-positive blood C or B-positive) donors in the U.S. Federal agencies, including the FDA
donors about ways to improve the This proposed study’s findings will Blood Products Advisory Committee,
disclosure of HIV risks during donor also yield insights into improved
the HHS Advisory committee on Blood
eligibility assessment to better methods for donor self-selection and
Safety and Availability, the AABB
understand the motivating factors that qualification post donation, which will
serve to decrease the frequency of Transfusion-Transmitted Diseases
drive higher risk persons to donate
blood. higher-risk persons acting as donors. Committee, and the Americas Blood
Because our study will build off the Our findings on improved methods for Centers (ABC). We anticipate similar
routine blood donor procedures in four Brazilian donor notification and linkage requests for results generated from this
large blood banks in Brazil, it may lead to health care services may also be study. Data collected in this proposed
to more informed conversations around applicable to developed countries, HIV Notification study of donors will be
and possible changes in donor including the U.S. Results of the Brazil of practical use to the blood banking
screening, notification and counseling Notification Study will identify how to and infectious disease communities in
policies in Latin America. Results of improve notification and counseling the U.S. and internationally.
these three aims may also help to better strategies that increase the number of OMB approval is requested for 3
integrate blood centers within the HIV-positive donors seeking prompt years. There are no costs to respondents
context of broader HIV testing, medical care. This might ultimately other than their time. The total
counseling and treatment sites in Brazil. boost strategies to prevent secondary estimated annualized burden hours are
Similarly, in the US little is known HIV transmission and reduce the risk of 229.
about donor behavior after notification transfusion-transmission.
ESTIMATED ANNUALIZED BURDEN HOURS
Estimated
Number of Average
Type of Number of total annual
Form name responses per burden per
respondent respondents burden hours
respondent response requested
ACASI Questionnaire—Informed Consent .............. Adults ........................ 275 1 10/60 46
ACASI Questionnaire ............................................... Adults ........................ 275 1 40/60 183
Dated: April 2, 2015. The meetings will be closed to the Room 715, MSC 5452, Bethesda, MD 20892,
Lynn Susulske, public in accordance with the (301) 594–8843, stanfibr@niddk.nih.gov.
NHLBI Project Clearance Liaison, National provisions set forth in sections Name of Committee: National Diabetes and
Institutes of Health. 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., Digestive and Kidney Diseases Advisory
[FR Doc. 2015–07980 Filed 4–7–15; 8:45 am] as amended. The grant applications and Council; Kidney, Urologic and Hematologic
<FNP> the discussions could disclose Diseases Subcommittee.
confidential trade secrets or commercial Date: May 13, 2015.
property such as patentable material, Open: 1:00 p.m. to 2:00 p.m.
DEPARTMENT OF HEALTH AND and personal information concerning Agenda: To review the Division’s scientific
individuals associated with the grant and planning activities.
HUMAN SERVICES
Place: National Institutes of Health,
applications, the disclosure of which
National Institutes of Health Building 31, 31 Center Drive, Conference
would constitute a clearly unwarranted Room 7, Bethesda, MD 20892.
invasion of personal privacy. Closed: 2:00 p.m. to 4:00 p.m.
National Institute of Diabetes and
Digestive and Kidney Diseases; Notice Name of Committee: National Diabetes and Agenda: To review and evaluate grant
Digestive and Kidney Diseases Advisory applications.
of Meetings
Council. Place: National Institutes of Health,
Pursuant to section 10(d) of the Date: May 13, 2015. Building 31, 31 Center Drive, Conference
Open: 8:30 a.m. to 12:00 p.m. Room 7, Bethesda, MD 20892.
Federal Advisory Committee Act, as
Agenda: To present the Director’s Report Contact Person: Brent B. Stanfield, Ph.D.,
amended (5 U.S.C. App.), notice is and other scientific presentations.
hereby given of meetings of the National Director, Division of Extramural Activities,
Place: National Institutes of Health, National Institutes of Diabetes and Digestive
Diabetes and Digestive and Kidney Building 31, 31 Center Drive, Conference and Kidney Diseases, 6707 Democracy Blvd.,
Diseases Advisory Council. Room 10, Bethesda, MD 20892. Room 715, MSC 5452, Bethesda, MD 20892,
The meetings will be open to the Closed: 4:15 p.m. to 4:30 p.m.
asabaliauskas on DSK5VPTVN1PROD with NOTICES
(301) 594–8843, stanfibr@niddk.nih.gov.
public as indicated below, with Agenda: To review and evaluate grant
applications. Name of Committee: National Diabetes and
attendance limited to space available. Digestive and Kidney Diseases Advisory
Individuals who plan to attend and Place: National Institutes of Health,
Building 31, 31 Center Drive, Conference Council; Digestive Diseases and Nutrition
need special assistance, such as sign Room 10, Bethesda, MD 20892. Subcommittee.
language interpretation or other Contact Person: Brent B. Stanfield, Ph.D., Date: May 13, 2015
reasonable accommodations, should Director, Division of Extramural Activities, Open: 1:00 p.m. to 2:30 p.m.
notify the Contact Person listed below National Institutes of Diabetes and Digestive Agenda: To review the Division’s scientific
in advance of the meeting. and Kidney Diseases, 6707 Democracy Blvd., and planning activities.
VerDate Sep<11>2014 17:55 Apr 07, 2015 Jkt 235001 PO 00000 Frm 00049 Fmt 4703 Sfmt 4703 E:\FR\FM\08APN1.SGM 08APN1](https://thefederalregister.org/doc/80_FR_18920/page/2.svg)
Document Created: 2018-02-21 10:06:58
Document Modified: 2018-02-21 10:06:58
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Dates | Comment 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. | |
| FR Citation | 80 FR 18853 |
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