Document Headings

                    Document headings vary by document type but may contain                    the following:                  
                -                       the agency or agencies that issued and signed a document                    
                -                       the number of the CFR title and the number of each part                      the document amends, proposes to amend, or is directly                      related to                    
                -                       the agency docket number / agency internal file number                    
                -                       the RIN which identifies each regulatory action listed in                      the Unified Agenda of Federal Regulatory and Deregulatory                      Actions                    

                    See the                                          Document Drafting Handbook                                        for more details.                  

###### Department of Health and Human Services

###### Health Resources and Services Administration

# AGENCY:

Health Resources and Services Administration (HRSA), HHS.

      ( print 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                               ( print 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                               ( print 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