Privacy Act of 1974; New System of Records, 46228-46231 [07-4019]

Download as PDF 46228 Federal Register / Vol. 72, No. 159 / Friday, August 17, 2007 / Notices Lakeville, Minnesota; and Brian Bauer, Garvin, Minnesota; to acquire voting shares of Access Bancshares, Inc., and thereby indirectly acquire voting shares of Access Bank, both of Champlin, Minnesota. Board of Governors of the Federal Reserve System, August 13, 2007. Jennifer J. Johnson, Secretary of the Board. [FR Doc. E7–16183 Filed 8–16–07; 8:45 am] BILLING CODE 6210–01–S FEDERAL RESERVE SYSTEM Notice of Proposals to Engage in Permissible Nonbanking Activities or to Acquire Companies that are Engaged in Permissible Nonbanking Activities The companies listed in this notice have given notice under section 4 of the Bank Holding Company Act (12 U.S.C. 1843) (BHC Act) and Regulation Y (12 CFR Part 225) to engage de novo, or to acquire or control voting securities or assets of a company, including the companies listed below, that engages either directly or through a subsidiary or other company, in a nonbanking activity that is listed in § 225.28 of Regulation Y (12 CFR 225.28) or that the Board has determined by Order to be closely related to banking and permissible for bank holding companies. Unless otherwise noted, these activities will be conducted throughout the United States. Each notice is available for inspection at the Federal Reserve Bank indicated. The notice also will be available for inspection at the offices of the Board of Governors. Interested persons may express their views in writing on the question whether the proposal complies with the standards of section 4 of the BHC Act. Additional information on all bank holding companies may be obtained from the National Information Center website at www.ffiec.gov/nic/. Unless otherwise noted, comments regarding the applications must be received at the Reserve Bank indicated or the offices of the Board of Governors not later than September 4, 2007. A. Federal Reserve Bank of New York (Anne MacEwen, Bank Applications Officer) 33 Liberty Street, New York, New York 10045-0001: 1. HSH Nordbank AG, Hamburg, Germany; to engage through a joint venture investment, in financial and investment advisory activities, pursuant to section 225.28(b)(6)(i) of Regulation Y. Board of Governors of the Federal Reserve System, August 14, 2007. Robert deV. Frierson, Deputy Secretary of the Board. [FR Doc. E7–16214 Filed 8–16–07; 8:45 am] BILLING CODE 6210–01–S GENERAL SERVICES ADMINISTRATION [FMR Bulletin PBS–2007–B3] Federal Management Regulation; Redesignations of Federal Buildings AGENCY: Public Buildings Service (P), GSA ACTION: Notice of a bulletin. SUMMARY: The attached bulletin announces the redesignations of (6) Federal Buildings. EXPIRATION DATE: This bulletin expires January 1, 2008. However, the building redesignation announced by this bulletin will remain in effect until canceled or superseded. FOR FURTHER INFORMATION CONTACT: General Services Administration, Public Buildings Service (P), Attn: Anthony E. Costa, 1800 F. Street, NW., Washington, DC 20405, e-mail at anthony.costa@gsa.gov. (202) 501–1100. Dated: July 25, 2007 LURITA DOAN, Administrator of General Services U.S. GENERAL SERVICES ADMINISTRATION FMR BULLETIN PBS–2007–B3 REDESIGNATIONS OF FEDERAL BUILDINGS TO: Heads of Federal Agencies SUBJECT: Redesignations of Federal Buildings 1. What is the purpose of this bulletin? This bulletin announces the redesignations of (6) Federal Buildings. 2. When does this bulletin expire? This bulletin expires January 1, 2008. However, the building redesignations announced by this bulletin will remain in effect until canceled or superseded. 3. Redesignations. The former and new names of the redesignated buildings are as follows: New Name United States Courthouse, 555 Independence Street, Cape Girardiau, MO 63703 United States Courthouse, 106 South Federal Plaza, Santa Fe, NM 87501 Department of Education Building, 400 Maryland Avenue, SW., Washington, DC 20202 Clifford Davis Federal Building, 167 North Main Street, Memphis, TN 38103 Federal Building and United States Courthouse and Customhouse, 515 West First Street, Duluth, MN 55802 United States Courthouse, 2500 Tulare Street, Fresno, CA 93721 ebenthall on PRODPC61 with NOTICES Former Name Rush Hudson Limbaugh, Sr. United States Courthouse, 555 Independence Street, Cape Girardeau, MO 63703 Santiago E. Campos United States Courthouse, 106 South Federal Plaza,Santa Fe, NM 87501 Lyndon Baines Johnson Department of Education Building, 400 Maryland Avenue, SW., Washington, DC 20202 Clifford Davis and Odell Horton Federal Building, 167 North Main Street, Memphis, TN 38103 Gerald W. Heany Federal Building and United States Courthouse and Customhouse, 515 West First Street, Duluth, MN 55802 Robert E. Coyle United States Courthouse, 2500 Tulare Street, Fresno, CA 93721 4. Who should we contact for further information regarding redesignation of these Federal Buildings? U.S. General Services Administration, Public Buildings Service (P),Attn: Anthony E, Costa, 1800 F. Street, NW., Washington, DC 20405, telephone number: (202) 501–1100, e-mail at anthony.costa@gsa.gov. DEPARTMENT OF HEALTH AND HUMAN SERVICES [FR Doc. E7–15989 Filed 8–16–07; 8:45 am] Health Resources and Services Administration BILLING CODE 6820–23–S Privacy Act of 1974; New System of Records Health Resources and Services Administration (HRSA), HHS. AGENCY: VerDate Aug<31>2005 15:36 Aug 16, 2007 Jkt 211001 PO 00000 Frm 00035 Fmt 4703 Sfmt 4703 E:\FR\FM\17AUN1.SGM 17AUN1 Federal Register / Vol. 72, No. 159 / Friday, August 17, 2007 / Notices Notification of New System of Records. ebenthall on PRODPC61 with NOTICES ACTION: SUMMARY: In accordance with the requirements of the Privacy Act, the Health Resources and Services Administration (HRSA) is publishing notice of a proposal to establish a new system of records. The Stem Cell Therapeutic and Research Act of 2005 (the Act) authorizes the C.W. Bill Young Cell Transplantation Program (the Program) and provides for the collection, maintenance, and distribution of human blood stem cells for the treatment of patients and for research. The Program consists of four interrelated components each operated under a separate contract. The four components are: The Bone Marrow Coordinating Center; the Cord Blood Coordinating Center; the Office of Patient Advocacy/Single Point of Access; and the Stem Cell Therapeutic Outcomes Database. The contracts for operation of the Bone Marrow Coordinating Center, Cord Blood Coordinating Center, and Office of Patient Advocacy/Single Point of Access were awarded to the National Marrow Donor Program in September, 2006. A single contract for the Stem Cell Therapeutic Outcomes Database was awarded to the Center for International Blood and Marrow Transplant Research (CIBMTR) at the Medical College of Wisconsin in September, 2006 as well. As identified by the Act, the Program is charged with: Operating a system for identifying, matching, and facilitating the distribution of bone marrow that is suitably matched to candidate patients; operating a system for identifying, matching, and facilitating the distribution of donated umbilical cord blood units that are suitably matched to candidate patients; providing a means by which transplant physicians, other healthcare professionals, and patients can electronically search for and access all available adult marrow donors available through the Program; recruiting potential adult volunteer marrow donors; coordinating with other Federal programs to maintain and expand medical contingency response capabilities; carrying out informational and educational activities; providing patient advocacy services; providing case management services for potential donors; and collecting, analyzing, and publishing blood stem cell transplantation related data in a standardized electronic format. This system of records is required to comply with the implementation directives of the Act, Public Law 109–129. The records will be used for the C.W. Bill Young Cell Transplantation Program’s VerDate Aug<31>2005 15:36 Aug 16, 2007 Jkt 211001 46229 planning, implementation, evaluation, monitoring, and document storage purposes. SECURITY CLASSIFICATION: HRSA invites interested parties to submit comments on the proposed New System of Records on or before September 26, 2007. As of the date of the publication of this Notice, HRSA has sent a Report of New System of Records to Congress and to the Office of Management and Budget (OMB). The New System of Records will be effective 40 days from the date submitted to OMB unless HRSA receives comments that would result in contrary determination. Data collected by the C.W. Bill Young Cell Transplantation Program (the Program) are maintained by the National Marrow Donor Program (NMDP) and the Medical College of Wisconsin, contractors for the Program. The Division of Transplantation within the Health Resources and Service Administration oversees the Program and the contracts with the NMDP and Medical College of Wisconsin. Records associated with the C.W. Bill Young Cell Transplantation Program are located at the National Marrow Donor Program, 3001 Broadway Street, NE., Suite 500, Minneapolis, MN 55413. Additional records associated with the Stem Cell Therapeutic Outcomes Database component of the Program are located at the Medical College of Wisconsin’s Center for International Blood and Marrow Transplant Research (CIBMTR), 8701 Watertown Plank Road, Milwaukee, WI 53226. DATES: Please address comments to Health Resources and Services Administration Privacy Act Coordinator, Donn Taylor, 5600 Fishers Lane, Room 14A–20, Rockville, Maryland 20857; telephone (301) 443– 0204. This is not a toll-free number. Comments received will be available for inspection at this same address from 9 a.m. to 3 p.m., Monday through Friday. ADDRESSES: FOR FURTHER INFORMATION CONTACT: James F. Burdick, M.D., Director, Division of Transplantation, HSB, HRSA, 5600 Fishers Lane, Room 12C– 06, Rockville, Maryland 20857; telephone (301) 443–7577; fax (301) 594–6095; or e-mail: jburdick@hrsa.gov. This is not a toll-free number. The Health Resources and Services Administration proposes to establish a new system of records: ‘‘C.W. Bill Young Cell Transplantation Program’’. The Stem Cell Therapeutic and Research Act of 2005 establishes the C.W. Bill Young Cell Transplantation Program which maintains information related to patients in need of a blood stem cell transplant and potential adult volunteer blood stem cell donors who have agreed to be listed on the registry maintained by the Program. Additionally, the Program maintains information related to the outcomes of patients who have undergone blood stem cell transplantation. SUPPLEMENTARY INFORMATION: Dated: August 7, 2007. Elizabeth M. Duke, Administrator. 09–15–0068 SYSTEM NAME: The ‘‘C.W. Bill Young Cell Transplantation Program,’’ which is comprised of the Office of Patient Advocacy/Single Point of Access, the Bone Marrow Coordinating Center, the Cord Blood Coordinating Center, and the Stem Cell Therapeutic Outcomes Database. PO 00000 Frm 00036 Fmt 4703 Sfmt 4703 None. SYSTEM LOCATION: CATEGORIES OF INDIVIDUALS COVERED BY THE SYSTEM: 1. Volunteers whose bone marrow, peripheral blood or cord blood donations are to be used for hematopoietic reconstitution or other therapeutic applications on behalf of patients in need. 2. Patients searching for an unrelated donor or who are served by the C.W. Bill Young Cell Transplantation Program. 3. Recipients of allogeneic blood stem cell transplantation. CATEGORIES OF RECORDS IN THE SYSTEM: Records consist of documents (printed and electronic) containing all information necessary to manage and facilitate patient searches and to track detailed post-transplant clinical status, including but not limited to documentation and correspondence concerning patients in need of (or recipients of) blood stem cell transplants and volunteers listed on the Program’s registry as potential blood stem cell donors. These documents include all information necessary to manage and facilitate patient searches, and to track detailed post-transplant clinical status. Information maintained in the system may include, but is not limited to: Name, Social Security number (voluntary), identifiers assigned by the contractors, transplant center and provider number, State and zip code of residence, citizenship, race/ethnicity, gender, date and time of transplantation or donation, name of transplant center E:\FR\FM\17AUN1.SGM 17AUN1 46230 Federal Register / Vol. 72, No. 159 / Friday, August 17, 2007 / Notices (or other identifier), histocompatibility status, patient condition before and after transplantation, immunosuppressive medication, cause of death (if appropriate), health care coverage, and employment. AUTHORITY FOR MAINTENANCE OF THE SYSTEM: Public Law 109–129 establishes the C.W. Bill Young Cell Transplantation Program, authorizing the Department to establish by contract a system for identifying, matching and facilitating bone marrow and cord blood transplants, including recruitment, patient advocacy and maintenance of a stem cell therapeutic outcomes database. PURPOSE(S): The purpose of the system is to support the Program’s mission to facilitate and increase access to blood stem cell transplantation. Additionally, the collection of accurate information will be used to advise the Secretary of the Department of Health and Human Services and the Advisory Council on Blood Stem Cell Transplantation on matters related to the Program and for ongoing monitoring of the Program by the Health Resources and Services Administration. ebenthall on PRODPC61 with NOTICES ROUTINE USES OF RECORDS MAINTAINED IN THE SYSTEM, INCLUDING CATEGORIES OF USERS AND THE PURPOSES OF SUCH USES: Any disclosure of records or information contained therein related to the Program will be made with the intent of providing and disseminating accurate and timely information required by patients, physicians, donors and the Program to facilitate and increase access to blood stem cell transplantation. 1. Departmental contractors who have been engaged by the Department to assist in accomplishment of a departmental function related to the purposes for this system of records and who need to have access to the records in order to assist the Department. 2. HRSA, acting through its contractors, may disclose information regarding blood stem cell donors, blood stem cell transplant candidates, and blood stem cell transplant recipients to transplant centers and NMDP participating organizations provided that such disclosure is compatible with the purpose for which the records were collected including: matching donor blood stem cells with recipients, monitoring compliance of member organizations with contractor requirements, reviewing and reporting periodically to the public on the status of blood stem cell donation and VerDate Aug<31>2005 15:36 Aug 16, 2007 Jkt 211001 transplantation in the United States. This information may consist of donor or patient identification information, and pertinent medical information. 3. Disclosures of certain information may be made to personnel involved in the care and management of volunteer blood stem cell donors. Disclosures of certain information may be made to patients or their designated representatives for purposes of facilitating searches for blood stem cell donors or products and/or facilitation of unrelated donor transplants. 4. Disclosures may be made by and between the contractors for the Office of Patient Advocacy/Single Point of Access, the Bone Marrow Coordinating Center, the Cord Blood Coordinating Center, the Stem Cell Therapeutic Outcomes Database, and NMDP participating centers for purposes of carrying out the statutory charge of the C.W. Bill Young Cell Transplantation Program. 5. In the event of litigation where the defendant is (a) The Department, any component of the Department, or any employee of the Department in his or her official capacity; (b) the United States where the Department determines that the claim, if successful, is likely to affect directly the operation of the Department or any of its components; or (c) any Department employee in his or her individual capacity where the Department of Justice has agreed to represent such employee, for example, in defending a claim against the Public Health Service in connection with such individual, disclosure may be made to the Department of Justice to enable the Department to present an effective defense. 6. Disclosure may be made to a congressional office from the record of an individual in response to a verified inquiry from the congressional office made at the written request of that individual. 7. Disclosure may be made for research purposes, when the Department, independently or through its contractor(s): (a) Has determined that the use or disclosure does not violate legal or policy limitations under which the record was provided, collected, or obtained; (b) has determined that a bona fide research/analysis purpose exists; (c) has required the recipient to: (1) Establish strict limitations concerning the receipt and use of patient-identified data; (2) establish reasonable administrative, technical, and physical safeguards to protect the confidentiality of the data and to prevent the unauthorized use or disclosure of the record; (3) remove, destroy, or return the information that identifies the PO 00000 Frm 00037 Fmt 4703 Sfmt 4703 individual at the earliest time at which removal or destruction can be accomplished consistent with the purpose of the research project, unless the recipient has presented adequate justification of a research or health nature for retaining such information; and (4) make no further use of disclosure of the record except as authorized by HRSA or its contractor(s) or when required by law; (d) has determined that other applicable safeguards or protocols will be followed; and (e) has secured a written statement attesting to the recipient’s understanding of, and willingness to abide by these provisions. POLICIES AND PRACTICES FOR STORING, RETRIEVING, ACCESSING, RETAINING, AND DISPOSING OF RECORDS IN THE SYSTEM: STORAGE: Records are maintained in file folders and in computer data files. RETRIEVABILITY: Retrieval of donor or patient records will be limited to authorized users for search or transplant management purposes. Patient records are retrieved using a unique ID number assigned to patients once registered in the system by the transplant center managing their care or through the use of other identifying information. Donor records may be retrieved by a unique ID assigned by the system or through the use of other identifying information. SAFEGUARDS: 1. Authorized Users: Access is limited to authorized contract personnel responsible for administering the program. Authorized personnel include the program managers/program specialists who have responsibilities for implementing the program and the HRSA Information Systems Security Officer. The contractor(s) shall maintain current lists of authorized users. 2. Assign Responsibility for Security: Responsibility is assigned to a management official knowledgeable of the nature of the information and processes supported by the C.W. Bill Young Cell Transplantation Program and in the management, personnel, operational, and technical controls used to protect it. 3. Perform Risk Assessment: A risk assessment was conducted in conjunction with the development of the system. The system design ensures vulnerabilities, risks, and other security concerns are identified and addressed in the system design and throughout the life cycle of the project. This is consistent with the HHS Automated E:\FR\FM\17AUN1.SGM 17AUN1 Federal Register / Vol. 72, No. 159 / Friday, August 17, 2007 / Notices Information Systems Security Program Handbook. 4. Certification and Accreditation: The Program’s electronic data systems are certified under the auspices of HRSA’s Office of Information Technology Certification and Accreditation system. 5. Physical Safeguards: All computer equipment and files and hard copy files are stored in areas where fire and life safety codes are strictly enforced. All automated and non-automated documents are protected on a 24-hour basis. Perimeter security includes intrusion alarms, key/passcard/ combination controls, and receptionist controlled area. Most hard copy files are maintained in a file room used solely for this purpose with access limited by combination lock to authorized users identified above. Computer files are password protected and are accessible only by use of computers which are password protected. 6. Procedural Safeguards: A password is required to access computer files. All users of personal information in connection with the performance of their jobs protect information from public view and from unauthorized personnel entering an unsupervised area. All authorized users sign a nondisclosure statement. All passwords, keys and/or combinations are changed when a person leaves or no longer has authorized duties. Access to records is limited to those authorized personnel trained in accordance with the Privacy Act and ADP security procedures. The transmission of records is protected using secure protocols. Individuals with access to the system have User IDs and passwords and must be granted access to the system. External access to the data requires two-factor authentication. The contractor(s) shall maintain current lists of authorized users. The safeguards described above were established in accordance with NIST 800–53 and OMB Circular A–130 Appendix III. RETENTION AND DISPOSAL: Patient and donor records will be retained indefinitely. SYSTEM MANAGER AND ADDRESS: Director, Blood Stem Cell Transplantation Program, HRSA, Parklawn Building, Room 12C–06, 5600 Fishers Lane, Rockville, MD 20857. ebenthall on PRODPC61 with NOTICES NOTIFICATION PROCEDURE: Requests must be made to the System Manager. Requests by mail: Requests for information and/or access to records received by mail must contain information providing the identity of VerDate Aug<31>2005 15:36 Aug 16, 2007 Jkt 211001 the writer, and a reasonable description of the record desired, and whom it concerns. Written requests must contain the name and address of the requester, his/her date of birth and his/her signature. Requests must be notarized to verify the identity of the requester, or the requester must certify that (s)he is the individual who (s)he claims to be and that (s)he understands that to knowingly and willfully request or acquire a record pertaining to another individual under false pretenses is a criminal offense under the Privacy Act subject to a $5,000 fine (45 CFR 5b.5(b)(2)(ii)). Requests in person or by telephone, electronic mail or facsimile cannot be honored. 46231 blood stem cell transplantation (e.g., transplant center healthcare professionals). SYSTEMS EXEMPTED FROM CERTAIN PROVISIONS OF THE ACT: None. [FR Doc. 07–4019 Filed 8–16–07; 8:45 am] BILLING CODE 4165–15–M DEPARTMENT OF HOMELAND SECURITY [Docket No. DHS–2007–0062] No requests in person at the system location will be honored. Science and Technology Directorate; Submission for Review; DHS S&T BAA Web Site Registration Form; DHS S&T BAA Registration Form; DHS S&T BAA White Paper and Proposal Submission Form; DHS S&T RFI Response Form REQUESTS BY TELEPHONE: AGENCY: REQUESTS IN PERSON: Since positive identification of the caller cannot be established, telephone requests are not honored. RECORD ACCESS PROCEDURES: Record access procedures are the same as notification procedures. Requesters should also provide a reasonable description of the contents of the record being sought. A parent or guardian who requests notification of, or access to, a minor’s/incompetent person’s record shall designate a family physician or other health professional (other than a family member) to whom the record, if any, will be sent. The parent or guardian must verify relationship to the minor/incompetent person as well as his/her own identity. Records will be mailed only to the requester’s address that is on file, unless a different address is demonstrated by official documentation. CONTESTING RECORD PROCEDURES: To contest a record in the system, contact the official at the address specified above and reasonably identify the record, specify the information being contested, and state the corrective action sought and the reason(s) for requesting the correction, along with supporting documentation to show how the record is inaccurate, incomplete, untimely, or irrelevant. RECORD SOURCE CATEGORIES: Sources of records include, but are not limited to, patients, donors, and/or their representatives under the C.W. Bill Young Cell Transplantation Program and any other sources of information or documentation submitted by any other person or entity for inclusion in a request for the purpose of facilitating PO 00000 Frm 00038 Fmt 4703 Sfmt 4703 Science and Technology Directorate, DHS. ACTION: 60-day Notice and request for comment. SUMMARY: The Department of Homeland Security (DHS) invites the general public to comment on new data collection forms for collecting Request for Information (RFI) responses and unclassified white papers and proposals through the Broad Agency Announcement (BAA) Web site. The forms will standardize the collection of information that is both necessary and sufficient for the DHS S&T Directorate to record and track the receipt of RFI responses, unclassified white papers, and proposals. As explained herein, these forms are intended to eliminate cost and delay associated with the submission and review of documents received via nonelectronic means and to improve tracking and records keeping. The Department is committed to improving its BAA processes and invites interested persons to comment on the following forms and instructions (hereinafter ‘‘Forms Package’’) for the (BAA) program: (1) DHS Science and Technology (S&T) BAA Web Site Registration (DHS FORM 10025), (2) DHS S&T BAA Registration (DHS FORM 10027), (3) DHS S&T BAA White Paper and Proposal Submission (DHS FORM 10026), and (4) DHS S&T RFI Response (DHS FORM 10028). This notice and request for comments is required by the Paperwork Reduction Act of 1995 (Pub. L. 104–13, 44 U.S.C. chapter 35). DATES: Comments are encouraged and will be accepted until October 16, 2007. ADDRESSES: You may submit comments, identified by docket number [DHS– E:\FR\FM\17AUN1.SGM 17AUN1

Agencies

[Federal Register Volume 72, Number 159 (Friday, August 17, 2007)]
[Notices]
[Pages 46228-46231]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 07-4019]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Health Resources and Services Administration


Privacy Act of 1974; New System of Records

AGENCY: Health Resources and Services Administration (HRSA), HHS.

[[Page 46229]]


ACTION: Notification of New System of Records.

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

SUMMARY: In accordance with the requirements of the Privacy Act, the 
Health Resources and Services Administration (HRSA) is publishing 
notice of a proposal to establish a new system of records. The Stem 
Cell Therapeutic and Research Act of 2005 (the Act) authorizes the C.W. 
Bill Young Cell Transplantation Program (the Program) and provides for 
the collection, maintenance, and distribution of human blood stem cells 
for the treatment of patients and for research. The Program consists of 
four interrelated components each operated under a separate contract. 
The four components are: The Bone Marrow Coordinating Center; the Cord 
Blood Coordinating Center; the Office of Patient Advocacy/Single Point 
of Access; and the Stem Cell Therapeutic Outcomes Database. The 
contracts for operation of the Bone Marrow Coordinating Center, Cord 
Blood Coordinating Center, and Office of Patient Advocacy/Single Point 
of Access were awarded to the National Marrow Donor Program in 
September, 2006. A single contract for the Stem Cell Therapeutic 
Outcomes Database was awarded to the Center for International Blood and 
Marrow Transplant Research (CIBMTR) at the Medical College of Wisconsin 
in September, 2006 as well.
    As identified by the Act, the Program is charged with: Operating a 
system for identifying, matching, and facilitating the distribution of 
bone marrow that is suitably matched to candidate patients; operating a 
system for identifying, matching, and facilitating the distribution of 
donated umbilical cord blood units that are suitably matched to 
candidate patients; providing a means by which transplant physicians, 
other healthcare professionals, and patients can electronically search 
for and access all available adult marrow donors available through the 
Program; recruiting potential adult volunteer marrow donors; 
coordinating with other Federal programs to maintain and expand medical 
contingency response capabilities; carrying out informational and 
educational activities; providing patient advocacy services; providing 
case management services for potential donors; and collecting, 
analyzing, and publishing blood stem cell transplantation related data 
in a standardized electronic format. This system of records is required 
to comply with the implementation directives of the Act, Public Law 
109-129. The records will be used for the C.W. Bill Young Cell 
Transplantation Program's planning, implementation, evaluation, 
monitoring, and document storage purposes.

DATES: HRSA invites interested parties to submit comments on the 
proposed New System of Records on or before September 26, 2007. As of 
the date of the publication of this Notice, HRSA has sent a Report of 
New System of Records to Congress and to the Office of Management and 
Budget (OMB). The New System of Records will be effective 40 days from 
the date submitted to OMB unless HRSA receives comments that would 
result in contrary determination.

ADDRESSES: Please address comments to Health Resources and Services 
Administration Privacy Act Coordinator, Donn Taylor, 5600 Fishers Lane, 
Room 14A-20, Rockville, Maryland 20857; telephone (301) 443-0204. This 
is not a toll-free number. Comments received will be available for 
inspection at this same address from 9 a.m. to 3 p.m., Monday through 
Friday.

FOR FURTHER INFORMATION CONTACT: James F. Burdick, M.D., Director, 
Division of Transplantation, HSB, HRSA, 5600 Fishers Lane, Room 12C-06, 
Rockville, Maryland 20857; telephone (301) 443-7577; fax (301) 594-
6095; or e-mail: jburdick@hrsa.gov. This is not a toll-free number.

SUPPLEMENTARY INFORMATION: The Health Resources and Services 
Administration proposes to establish a new system of records: ``C.W. 
Bill Young Cell Transplantation Program''. The Stem Cell Therapeutic 
and Research Act of 2005 establishes the C.W. Bill Young Cell 
Transplantation Program which maintains information related to patients 
in need of a blood stem cell transplant and potential adult volunteer 
blood stem cell donors who have agreed to be listed on the registry 
maintained by the Program. Additionally, the Program maintains 
information related to the outcomes of patients who have undergone 
blood stem cell transplantation.

    Dated: August 7, 2007.
Elizabeth M. Duke,
Administrator.
09-15-0068

System Name:
    The ``C.W. Bill Young Cell Transplantation Program,'' which is 
comprised of the Office of Patient Advocacy/Single Point of Access, the 
Bone Marrow Coordinating Center, the Cord Blood Coordinating Center, 
and the Stem Cell Therapeutic Outcomes Database.

Security Classification:
    None.

System Location:
    Data collected by the C.W. Bill Young Cell Transplantation Program 
(the Program) are maintained by the National Marrow Donor Program 
(NMDP) and the Medical College of Wisconsin, contractors for the 
Program. The Division of Transplantation within the Health Resources 
and Service Administration oversees the Program and the contracts with 
the NMDP and Medical College of Wisconsin.
    Records associated with the C.W. Bill Young Cell Transplantation 
Program are located at the National Marrow Donor Program, 3001 Broadway 
Street, NE., Suite 500, Minneapolis, MN 55413.
    Additional records associated with the Stem Cell Therapeutic 
Outcomes Database component of the Program are located at the Medical 
College of Wisconsin's Center for International Blood and Marrow 
Transplant Research (CIBMTR), 8701 Watertown Plank Road, Milwaukee, WI 
53226.

Categories of Individuals Covered by the System:
    1. Volunteers whose bone marrow, peripheral blood or cord blood 
donations are to be used for hematopoietic reconstitution or other 
therapeutic applications on behalf of patients in need.
    2. Patients searching for an unrelated donor or who are served by 
the C.W. Bill Young Cell Transplantation Program.
    3. Recipients of allogeneic blood stem cell transplantation.

Categories of Records in the System:
    Records consist of documents (printed and electronic) containing 
all information necessary to manage and facilitate patient searches and 
to track detailed post-transplant clinical status, including but not 
limited to documentation and correspondence concerning patients in need 
of (or recipients of) blood stem cell transplants and volunteers listed 
on the Program's registry as potential blood stem cell donors. These 
documents include all information necessary to manage and facilitate 
patient searches, and to track detailed post-transplant clinical 
status. Information maintained in the system may include, but is not 
limited to: Name, Social Security number (voluntary), identifiers 
assigned by the contractors, transplant center and provider number, 
State and zip code of residence, citizenship, race/ethnicity, gender, 
date and time of transplantation or donation, name of transplant center

[[Page 46230]]

(or other identifier), histocompatibility status, patient condition 
before and after transplantation, immunosuppressive medication, cause 
of death (if appropriate), health care coverage, and employment.

Authority for maintenance of the System:
    Public Law 109-129 establishes the C.W. Bill Young Cell 
Transplantation Program, authorizing the Department to establish by 
contract a system for identifying, matching and facilitating bone 
marrow and cord blood transplants, including recruitment, patient 
advocacy and maintenance of a stem cell therapeutic outcomes database.

Purpose(s):
    The purpose of the system is to support the Program's mission to 
facilitate and increase access to blood stem cell transplantation. 
Additionally, the collection of accurate information will be used to 
advise the Secretary of the Department of Health and Human Services and 
the Advisory Council on Blood Stem Cell Transplantation on matters 
related to the Program and for ongoing monitoring of the Program by the 
Health Resources and Services Administration.

Routine Uses of Records Maintained in the System, Including Categories 
of Users and the Purposes of Such Uses:
    Any disclosure of records or information contained therein related 
to the Program will be made with the intent of providing and 
disseminating accurate and timely information required by patients, 
physicians, donors and the Program to facilitate and increase access to 
blood stem cell transplantation.
    1. Departmental contractors who have been engaged by the Department 
to assist in accomplishment of a departmental function related to the 
purposes for this system of records and who need to have access to the 
records in order to assist the Department.
    2. HRSA, acting through its contractors, may disclose information 
regarding blood stem cell donors, blood stem cell transplant 
candidates, and blood stem cell transplant recipients to transplant 
centers and NMDP participating organizations provided that such 
disclosure is compatible with the purpose for which the records were 
collected including: matching donor blood stem cells with recipients, 
monitoring compliance of member organizations with contractor 
requirements, reviewing and reporting periodically to the public on the 
status of blood stem cell donation and transplantation in the United 
States. This information may consist of donor or patient identification 
information, and pertinent medical information.
    3. Disclosures of certain information may be made to personnel 
involved in the care and management of volunteer blood stem cell 
donors. Disclosures of certain information may be made to patients or 
their designated representatives for purposes of facilitating searches 
for blood stem cell donors or products and/or facilitation of unrelated 
donor transplants.
    4. Disclosures may be made by and between the contractors for the 
Office of Patient Advocacy/Single Point of Access, the Bone Marrow 
Coordinating Center, the Cord Blood Coordinating Center, the Stem Cell 
Therapeutic Outcomes Database, and NMDP participating centers for 
purposes of carrying out the statutory charge of the C.W. Bill Young 
Cell Transplantation Program.
    5. In the event of litigation where the defendant is (a) The 
Department, any component of the Department, or any employee of the 
Department in his or her official capacity; (b) the United States where 
the Department determines that the claim, if successful, is likely to 
affect directly the operation of the Department or any of its 
components; or (c) any Department employee in his or her individual 
capacity where the Department of Justice has agreed to represent such 
employee, for example, in defending a claim against the Public Health 
Service in connection with such individual, disclosure may be made to 
the Department of Justice to enable the Department to present an 
effective defense.
    6. Disclosure may be made to a congressional office from the record 
of an individual in response to a verified inquiry from the 
congressional office made at the written request of that individual.
    7. Disclosure may be made for research purposes, when the 
Department, independently or through its contractor(s): (a) Has 
determined that the use or disclosure does not violate legal or policy 
limitations under which the record was provided, collected, or 
obtained; (b) has determined that a bona fide research/analysis purpose 
exists; (c) has required the recipient to: (1) Establish strict 
limitations concerning the receipt and use of patient-identified data; 
(2) establish reasonable administrative, technical, and physical 
safeguards to protect the confidentiality of the data and to prevent 
the unauthorized use or disclosure of the record; (3) remove, destroy, 
or return the information that identifies the individual at the 
earliest time at which removal or destruction can be accomplished 
consistent with the purpose of the research project, unless the 
recipient has presented adequate justification of a research or health 
nature for retaining such information; and (4) make no further use of 
disclosure of the record except as authorized by HRSA or its 
contractor(s) or when required by law; (d) has determined that other 
applicable safeguards or protocols will be followed; and (e) has 
secured a written statement attesting to the recipient's understanding 
of, and willingness to abide by these provisions.

Policies and Practices For Storing, Retrieving, Accessing, Retaining, 
and Disposing of Records in the System:
Storage:
    Records are maintained in file folders and in computer data files.

Retrievability:
    Retrieval of donor or patient records will be limited to authorized 
users for search or transplant management purposes. Patient records are 
retrieved using a unique ID number assigned to patients once registered 
in the system by the transplant center managing their care or through 
the use of other identifying information. Donor records may be 
retrieved by a unique ID assigned by the system or through the use of 
other identifying information.

Safeguards:
    1. Authorized Users: Access is limited to authorized contract 
personnel responsible for administering the program. Authorized 
personnel include the program managers/program specialists who have 
responsibilities for implementing the program and the HRSA Information 
Systems Security Officer. The contractor(s) shall maintain current 
lists of authorized users.
    2. Assign Responsibility for Security: Responsibility is assigned 
to a management official knowledgeable of the nature of the information 
and processes supported by the C.W. Bill Young Cell Transplantation 
Program and in the management, personnel, operational, and technical 
controls used to protect it.
    3. Perform Risk Assessment: A risk assessment was conducted in 
conjunction with the development of the system. The system design 
ensures vulnerabilities, risks, and other security concerns are 
identified and addressed in the system design and throughout the life 
cycle of the project. This is consistent with the HHS Automated

[[Page 46231]]

Information Systems Security Program Handbook.
    4. Certification and Accreditation: The Program's electronic data 
systems are certified under the auspices of HRSA's Office of 
Information Technology Certification and Accreditation system.
    5. Physical Safeguards: All computer equipment and files and hard 
copy files are stored in areas where fire and life safety codes are 
strictly enforced. All automated and non-automated documents are 
protected on a 24-hour basis. Perimeter security includes intrusion 
alarms, key/passcard/combination controls, and receptionist controlled 
area. Most hard copy files are maintained in a file room used solely 
for this purpose with access limited by combination lock to authorized 
users identified above. Computer files are password protected and are 
accessible only by use of computers which are password protected.
    6. Procedural Safeguards: A password is required to access computer 
files. All users of personal information in connection with the 
performance of their jobs protect information from public view and from 
unauthorized personnel entering an unsupervised area. All authorized 
users sign a nondisclosure statement. All passwords, keys and/or 
combinations are changed when a person leaves or no longer has 
authorized duties. Access to records is limited to those authorized 
personnel trained in accordance with the Privacy Act and ADP security 
procedures. The transmission of records is protected using secure 
protocols. Individuals with access to the system have User IDs and 
passwords and must be granted access to the system. External access to 
the data requires two-factor authentication. The contractor(s) shall 
maintain current lists of authorized users. The safeguards described 
above were established in accordance with NIST 800-53 and OMB Circular 
A-130 Appendix III.

Retention and Disposal:
    Patient and donor records will be retained indefinitely.

System Manager and Address:
    Director, Blood Stem Cell Transplantation Program, HRSA, Parklawn 
Building, Room 12C-06, 5600 Fishers Lane, Rockville, MD 20857.

Notification Procedure:
    Requests must be made to the System Manager.
    Requests by mail: Requests for information and/or access to records 
received by mail must contain information providing the identity of the 
writer, and a reasonable description of the record desired, and whom it 
concerns. Written requests must contain the name and address of the 
requester, his/her date of birth and his/her signature. Requests must 
be notarized to verify the identity of the requester, or the requester 
must certify that (s)he is the individual who (s)he claims to be and 
that (s)he understands that to knowingly and willfully request or 
acquire a record pertaining to another individual under false pretenses 
is a criminal offense under the Privacy Act subject to a $5,000 fine 
(45 CFR 5b.5(b)(2)(ii)).
    Requests in person or by telephone, electronic mail or facsimile 
cannot be honored.

Requests in Person:
    No requests in person at the system location will be honored.

Requests By Telephone:
    Since positive identification of the caller cannot be established, 
telephone requests are not honored.

Record Access Procedures:
    Record access procedures are the same as notification procedures. 
Requesters should also provide a reasonable description of the contents 
of the record being sought. A parent or guardian who requests 
notification of, or access to, a minor's/incompetent person's record 
shall designate a family physician or other health professional (other 
than a family member) to whom the record, if any, will be sent. The 
parent or guardian must verify relationship to the minor/incompetent 
person as well as his/her own identity. Records will be mailed only to 
the requester's address that is on file, unless a different address is 
demonstrated by official documentation.

Contesting Record Procedures:
    To contest a record in the system, contact the official at the 
address specified above and reasonably identify the record, specify the 
information being contested, and state the corrective action sought and 
the reason(s) for requesting the correction, along with supporting 
documentation to show how the record is inaccurate, incomplete, 
untimely, or irrelevant.

Record Source Categories:
    Sources of records include, but are not limited to, patients, 
donors, and/or their representatives under the C.W. Bill Young Cell 
Transplantation Program and any other sources of information or 
documentation submitted by any other person or entity for inclusion in 
a request for the purpose of facilitating blood stem cell 
transplantation (e.g., transplant center healthcare professionals).

Systems Exempted From Certain Provisions of the Act:
    None.

[FR Doc. 07-4019 Filed 8-16-07; 8:45 am]
BILLING CODE 4165-15-M