SS_A_Attachment_10-Privacy_Act_System_of_Records

Supporting Statement A
Attachment 10
Privacy Act System of Records

09–25–0200

SYSTEM NAME:
Clinical, Basic and Population-based Research
Studies of the National Institutes of Health (NIH),
HHS/NIH/ OD.

SECURITY CLASSIFICATION:
None.
SYSTEM LOCATION:
Records are located at NIH and
Contractor research facilities which
collect or provide research data for this
system. Contractors may include, but
are not limited to: Research centers,
clinics, hospitals, universities, medical
schools, research institutions/
foundations, national associations,
commercial organizations, collaborating State and
Federal Government agencies, and coordinating
centers. A current list of sites, including the
address of any Federal Records Center where
records from this system may be stored, is
available by writing to the appropriate
Coordinator listed under Notification Procedure.
CATEGORIES OF INDIVIDUALS
COVERED BY THE SYSTEM:
Adults and/or children who are the subjects of
clinical, basic, or populationbased research studies
of the NIH.
Individuals with disease. Individuals who are
representative of the general population or of
special groups including, but not limited to:
normal controls, normal volunteers, family
members and relatives; providers of services (e.g.,
health care and social work); health care
professionals and educators, and demographic
sub-groups as applicable, such as age, sex,
ethnicity, race, occupation, geographic location;
and groups exposed to real and/or hypothesized
risks (e.g., exposure to biohazardous microbial
agents).

CATEGORIES OF RECORDS IN
THE SYSTEM:
The system contains data about individuals as
relevant to a particular research study. Examples
include, but are not limited to: name, study
identification number, address, relevant telephone
numbers, social security number (voluntary),
driver’s license number, date of birth, weight,
height, sex, race; medical, psychological and
dental information, laboratory and diagnostic
testing results; registries; social, economic and
demographic data; health services utilization;
insurance and hospital cost data, employers,
conditions of the work environment, exposure to
hazardous substances/ compounds; information
pertaining to stored biologic specimens (including
blood, urine, tissue and genetic materials),
characteristics and activities of health care
providers and educators and trainers (including
curricula vitae); and associated correspondence.

AUTHORITY FOR
MAINTENANCE OF THE
SYSTEM:
‘‘Research and Investigation,’’
‘‘Appointment and Authority of the
Directors of the National Research
Institutes,’’ ‘‘National Cancer Institute,’’
‘‘National Eye Institute,’’ ‘‘National
Heart, Lung and Blood Institute,’’
‘‘National Institute on Aging,’’ ‘‘National
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Institute on Alcohol Abuse and
Alcoholism,’’ ‘‘National Institute on
Allergy and Infectious Diseases,’’
‘‘National Institute of Arthritis and
Musculoskeletal and Skin Diseases,’’
‘‘National Institute of Child Health and
Human Development,’’ ‘‘National
Institute on Deafness and Other
Communication Disorders,’’ ‘‘National
Institute of Dental and Craniofacial

Research,’’ ‘‘National Institute of
Diabetes, and Digestive and Kidney
Diseases,’’ ‘‘National Institute of Drug
Abuse,’’ ‘‘National Institute of
Environmental Health Sciences,’’
‘‘National Institute of Mental Health,’’ ‘‘National
Institute of Neurological Disorders and Stroke,’’
and the ‘‘National Human Genome Research
Institute’’ of the Public Health Service Act. (42
U.S.C. 241, 242, 248, 281, 282, 284, 285a, 285b,
285c, 285d, 285e, 285f, 285g, 285h, 285i, 285j,
285l, 285m, 285n, 285o, 285p, 285q, 287, 287b,
287c, 289a, 289c, and 44 U.S.C. 3101.)

PURPOSE(S):
To document, track, monitor and
evaluate NIH clinical, basic, and
population-based research activities.
ROUTINE USES OF RECORDS
MAINTAINED IN THE SYSTEM,
INCLUDING CATEGORIES OF USERS
AND THE PURPOSES OF SUCH USES:
1. A record may be disclosed for a
research purpose, when the Department:
(A) Has determined that the use or
disclosure does not violate legal or
policy limitations under which the
record was provided, collected, or
obtained; e.g., disclosure of alcohol or drug abuse
patient records will be made only in accordance
with the restrictions of confidentiality statutes and
regulations 42 U.S.C. 241, 42 U.S.C.
290dd–2, 42 CFR part 2, and where
applicable, no disclosures will be made
inconsistent with an authorization of
confidentiality under 42 U.S.C. 241 and
42 CFR part 2a; (B) has determined that
the research purpose (1) cannot be
reasonably accomplished unless the
record is provided in individually
identifiable form, and (2) warrants the
risk to the privacy of the individual that
additional exposure of the record might
bring; © has required the recipient to
(1) establish reasonable administrative,
technical, and physical safeguards to
prevent unauthorized use or disclosure of

the record, (2) remove or destroy 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 (3) make no further use or
disclosure of the record except (a) in
emergency circumstances affecting the
health or safety of any individual, (b)
for
use in another research project, under
these same conditions, and with
written
authorization of the Department, © for
disclosure to a properly identified
person for the purpose of an audit
related to the research project, if
information that would enable research subjects to
be identified is removed or destroyed at the
earliest opportunity consistent with the purpose of
the audit, or (d) when required by law; and (D)
has secured a written statement attesting to the
recipient’s understanding of, and willingness to
abide by, these provisions.
2. Disclosure may be made to a
Member of Congress or to a
Congressional staff member in response to an
inquiry of the Congressional office made at
the written request of the constituent about
whom the record is maintained.
3. The Department of Health and
Human Services (HHS) may disclose
information from this system of records to the
Department of Justice when: (a) The agency
or any component thereof;
or (b) any employee of the agency in his
or her official capacity where the
Department of Justice has agreed to
represent the employee; or © the
United States Government, is a party to
litigation or has an interest in such
litigation, and by careful review, the
agency determines that the records are

both relevant and necessary to the
litigation and the use of such records by
the Department of Justice is, therefore,
deemed by the agency to be for a
purpose that is compatible with the
purpose for which the agency collected the
records.
4. Disclosure may be made to agency
contractors, grantees, experts, consultants,
collaborating researchers, or volunteers who
have been engaged by the agency to assist in
the performance of a service related to this
system of records and who need to have
access to the records in order to perform the
activity. Recipients shall be required to
comply with the requirements of the Privacy
Act of 1974, as amended, pursuant to 5 U.S.C.
552a(m).
5. Information from this system may
be disclosed to Federal agencies, State
agencies (including the Motor Vehicle
Administration and State vital statistics
offices, private agencies, and other third
parties (such as current or prior employers,
acquaintances, relatives), when necessary to
obtain information on morbidity and mortality
experiences and to locate individuals for
follow-up studies. Social security numbers,
date of birth and other identifiers may be
disclosed: (1) To the National Center for
Health Statistics to ascertain vital status
through the National Death Index; (2) to the
Health Care Financing Agency to ascertain
morbidities; and (3) to the Social Security
Administration to ascertain disabilities and/or
location of participants. Social security
numbers may also be given to other Federal
agencies, and State and local agencies when
necessary to locating individuals for
participation in follow-up studies.
6. Medical information may be
disclosed in identifiable form to tumor
registries for maintenance of health
statistics, e.g., for use in research
studies.
7. PHS may inform the sexual and/or needlesharing partner(s) of a subject individual who

is infected with the human immunodeficiency
virus (HIV)
of their exposure to HIV, under the
following circumstances: (1) The
information has been obtained in the
course of clinical activities at PHS
facilities carried out by PHS personnel
or contractors; (2) The PHS employee or
contractor has made reasonable efforts
to counsel and encourage the subject
individual to provide the information to
the individual’s sexual or needlesharing
partner(s); (3) The PHS
employee or contractor determines that
the subject individual is unlikely to
provide the information to the sexual or
needle-sharing partner(s) or that the
provision of such information cannot
reasonably be verified; and (4) The
notification of the partner(s) is made,
whenever possible, by the subject
individual’s physician or by a
professional counselor and shall follow standard
counseling practices.
PHS may disclose information to State or local
public health departments, to assist in the
notification of the subject individual’s sexual
and/or needlesharing partner(s), or in the
verification that the subject individual has notified
such sexual or needle-sharing partner(s).
8. Certain diseases and conditions,
including infectious diseases, may be reported
to appropriate representatives of State or
Federal Government as required by State or
Federal law.
9. Disclosure may be made to
authorized organizations which provide health
services to subject individuals or provide
third-party reimbursement or fiscal
intermediary functions, for the purpose of
planning for or providing such services,
billing or collecting thirdparty
reimbursements.
10. The Secretary may disclose
information to organizations deemed
qualified to carry out quality
assessment, medical audits or

utilization reviews.
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11. Disclosure may be made for the
purpose of reporting child, elder or spousal
abuse or neglect or any other type of abuse or
neglect as required by State or Federal law.
POLICIES AND PRACTICES FOR
STORING, RETRIEVING, ACCESSING,
RETAINING, AND DISPOSING OF
RECORDS IN THE SYSTEM:
STORAGE:
Records may be stored on index cards, file
folders, computer tapes and disks (including
optical disks), photography media, microfiche,
microfilm, and audio and video tapes. For
certain studies, factual data with study code
numbers are stored on computer tape or disk,
while the key to personal identifiers is stored
separately, without factual data, in
paper/computer files.

RETRIEVABILITY:
During data collection stages and
follow-up, retrieval is by personal
identifier (e.g., name, social security number,
medical record or study identification number,
etc.). During the data analysis stage, data are
normally retrieved by the variables of interest
(e.g., diagnosis, age, occupation).

SAFEGUARDS:
1. Authorized Users: Access to
identifiers and to link files is strictly limited to
the authorized personnel whose duties require
such access.
Procedures for determining authorized access
to identified data are established as
appropriate for each location.
Personnel, including contractor
personnel, who may be so authorized
include those directly involved in data

collection and in the design of research
studies, e.g., interviewers and
interviewer supervisors; project
managers; and statisticians involved in
designing sampling plans. Other onetime
and special access by other
employees is granted on a need-to-know
basis as specifically authorized by the
system manager. Researchers authorized
to conduct research on biologic
specimens will typically access the
system through the use of encrypted identifiers
sufficient to link individuals with records in such
a manner that does not compromise
confidentiality of the individual.
2. Physical Safeguards: Records are either stored
in locked rooms during offduty hours, locked
file cabinets, and/or secured computer
facilities. For certain studies, personal
identifiers and link files are separated and
stored in locked files. Computer data access is
limited through the use of key words known
only to authorized personnel.
3. Procedural Safeguards: Collection and
maintenance of data is consistent with
legislation and regulations in the protection of
human subjects, informed consent,
confidentiality, and confidentiality specific to
drug and
alcohol abuse patients where these
apply. When anonymous data is
provided to research scientists for
analysis, study numbers which can be matched to
personal identifiers will be eliminated, scrambled,
or replaced by the agency or contractor with
random numbers which cannot be matched.
Contractors who maintain records in this system
are instructed to make no further disclosure of the
records.
Privacy Act requirements are specifically included
in contracts for survey and research activities
related to this system. The OHS project directors,
contract officers, and project officers oversee
compliance with these requirements. Personnel
having access are trained in Privacy Act
requirements. Depending upon the sensitivity of
the information in the record, additional safeguard
measures may be employed.

4. Implementation Guidelines: These practices
are in compliance with the standards of
Chapter 45–13 of the HHS
General Administration Manual,
‘‘Safeguarding Records Contained in Systems
of Records,’’ supplementary Chapter PHS hf:
45–13, and the HHS Automated Information
Systems Security Program Handbook.

RETENTION AND DISPOSAL:
Records are retained and disposed of under the
authority of the NIH Records Control Schedule
contained in NIH Manual Chapter 1743,
Appendix 1—
‘‘Keeping and Destroying Records’’ (HHS
Records Management Manual, Appendix B–361),
item 3000–G–3, which allows records to be kept
as long as they are useful in scientific research.
Collaborative Perinatal Project records are
retained in accordance with item 3000–G–4,
which does not allow records to be destroyed.
Refer to the NIH Manual Chapter for specific
conditions on disposal or retention instructions.

SYSTEM MANAGER(S) AND
ADDRESS:
See Appendix I for a listing of current
System Managers. This system is for use
by all NIH Institutes and Centers.

NOTIFICATION PROCEDURE:
To determine if a record exists, write
to the appropriate IC Privacy Act
Coordinator listed below. In cases where
the requester knows specifically which
System Manager to contact, he or she
may contact the System Manager
directly (See Appendix I). Notification
requests should include: individual’s
name; current address; date of birth;
date, place and nature of participation
in specific research study; name of
individual or organization
administering the research study (if
known); name or description of the
research study (if known); address at the

time of participation; and in specific
cases, a notarized statement (some
highly sensitive systems require two
witnesses attesting to the individual’s
identity). A requester must verify his or
her identity by providing either a
notarization of the request or by
submitting a written certification that
the is who he or she claims to be and
understands that the knowing and
willful request for acquisition of a
record pertaining to an individual under false
pretenses is a criminal offense under the Act,
subject to a five thousand dollar fine.
Individuals will be granted direct
access to their medical records unless
the System Manager determines that
such access is likely to have an adverse
effect (i.e., could cause harm) on the
individual. In such cases when the
System Manager has determined that
the nature of the record information
requires medical interpretation, the
subject of the record shall be requested
to designate, in writing, a responsible
representative who will be willing to
review the record and inform the subject
individual of its contents at the
representative’s discretion. The
representative may be a physician, other
health professional, or other responsible
individual. In this case, the medical/
dental record will be sent to the
designated representative. Individuals
will be informed in writing if the record
is sent to the representative. This same
procedure will apply in cases where a
parent or guardian requests notification
of, or access to, a child’s or incompetent
person’s medical record. The parent or
guardian must also verify (provide
adequate documentation) their
relationship to the child or incompetent person as
well as his or her own identity to prove their
relationship.
If the requester does not know which
Institute or Center Privacy Act
Coordinator to contact for notification

purposes, he or she may contact directly
the NIH Privacy Act Officer at the
following address: NIH Privacy Act
Officer, Office of Management
Assessment, 6011 Executive Blvd.,
Room 601L, Rockville, MD 20852.

NIH Privacy Act Coordinators
Associate Director for Disease
Prevention, Office of the Director (OD), Building
1, Room 260, 1 Center Drive, Bethesda, MD
20892.
Privacy Act Coordinator, Clinical Center (CC),
Building 10, Room 1N208, 10 Center Drive,
Bethesda, MD 20892.
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Privacy Act Coordinator, National
Center for Complementary and
Alternative Medicine (NCCAM),
Building 31, Room 2B11, 31 Center Drive,
Bethesda, MD 20892–2182.
Privacy Act Coordinator, National Cancer
Institute (NCI), Building 31, Room 10A34, 31
Center Drive, Bethesda, MD 20892.
Privacy Act Coordinator, National Center on
Minority Health and Health Disparities
(NCMHD), Democracy Plaza II, Room 800, 6707
Democracy Boulevard, Bethesda, MD 20892–
5465. Privacy Act Coordinator, National Center
for Research Resources (NCRR), Rockledge I,
Room 5140, 6705 Rockledge Drive, Bethesda,
MD 20892. Privacy Act Coordinator, National
Eye Institute (NEI), Building 31, Room 6A32, 31
Center Drive, Bethesda, MD 20892–
2510.
Privacy Act Coordinator, National
Human Genome Research Institute
(NHGRI), Building 10, 3C710, 10 Center Drive,
Bethesda, MD 20892.
Privacy Act Coordinator, National

Heart, Lung, and Blood Institute
(NHLBI), Building 31, Room 5A33, 31 Center
Drive, Bethesda, MD 20892.
Privacy Act Coordinator, National
Institute on Aging (NIA), Gateway
Building 31, Room 2C234, 7201
Wisconsin Avenue, Bethesda, MD
20892.
Privacy Act Coordinator, National
Institute on Alcohol Abuse and
Alcoholism (NIAAA), Willco Building, Room
400, 6000 Executive Boulevard, Bethesda, MD
20892–7003.
Privacy Act Coordinator, National
Institute of Allergy and Infectious
Diseases (NIAID), 6700–B Rockledge Drive,
Room 2143, Bethesda, MD 20892.
Privacy Act Coordinator, National
Institute of Arthritis and
Musculoskeletal and Skin Diseases
(NIAMS), Natcher Building, Room
5AS49, 45 Center Drive, Bethesda, MD 20892.
Privacy Act Coordinator, National Institute of
Biomedical Imaging and Bioengineering (NIBIB),
Building 31, Room 1B37, 31 Center Drive,
Bethesda, MD 20892–2077.
Privacy Act Coordinator, National Institute of
Child Health and Human Development (NICHD),
Building 31, Room 2A11, 31 Center Drive,
Bethesda, MD 20892.
Privacy Act Coordinator, Office of
Extramural Affairs, National Institute on
Drug Abuse (NIDA), Neuroscience
Center, 6001 Executive Boulevard,
Room 3158, Bethesda, MD 20892–9547.
Privacy Act Coordinator, National
Institute on Deafness and Other
Communication Disorders (NIDCD), Building 31,
Room 3C02, 31 Center Drive, Bethesda, MD
20892.
Privacy Act Coordinator, National
Institute of Dental and Craniofacial
Research (NIDCR), Natcher Building,
Room 4AS25, 45 Center Drive,
Bethesda, MD 20892–6401.
Privacy Act Coordinator, National

Institute of Diabetes and Digestive and Kidney
Disease (NIDDK), Building 31, Room 9A47, 31
Center Drive, Bethesda, MD 20892.
Privacy Act Coordinator, National
Institute of Environmental Health
Sciences (NIEHS), PO Box 12233,
Research Triangle Park, NC 27709.
Privacy Act Coordinator, National
Institute of General Medical Sciences (NIGMS),
Natcher Building, Room 2AN32, 45 Center Drive,
Bethesda, MD 20892.
Privacy Act Coordinator, National
Institute of Mental Health (NIMH),
Neuroscience Center, 6001 Executive Boulevard,
Room 8102, Bethesda, MD 20892.
Privacy Act Coordinator, National Institute of
Neurological Disorders and Stroke (NINDS),
Building 31, Room 8A33, 31 Center Drive,
Bethesda, MD 20892.
Privacy Act Coordinator, National Institute of
Nursing Research (NINR), Rockledge II, Room
710, 6701 Rockledge Drive, Bethesda, MD
20892.

RECORD ACCESS
PROCEDURE:
Same as Notification Procedures.
Requesters should reasonably specify the record
contents being sought. An individual may also
request an accounting of disclosures of his/her
record, if any.

CONTESTING RECORD
PROCEDURE:
Contact the appropriate official at the address
specified under Notification Procedure, and
reasonably identify the record, specify the
information being contested, and state corrective
action sought, with supporting information to
show how the record is inaccurate, incomplete,
untimely, or irrelevant.

RECORD SOURCE
CATEGORIES:
The system contains information

obtained directly from the subject
individual by interview (face-to-face or
telephone), written questionnaire, or by
other tests, recording devices or
observations, consistent with legislation
and regulation regarding informed
consent and protection of human
subjects. Information is also obtained from other
sources, including but not limited to: referring
medical physicians, mental health/alcohol/drug
abuse or other health care providers; hospitals;
organizations providing biological specimens;
relatives; guardians; schools; and clinical medical
research records.
SYSTEMS EXEMPTED FROM CERTAIN
PROVISIONS OF THE ACT:
None.
Appendix I: System Manager(s) and
Address(es)
Associate Director for Disease Prevention, Office
of the Director (OD), Building 1, Room 260, 1
Center Drive, Bethesda, MD 20892.
Computer Systems Analyst, Division of
Cancer Treatment and Diagnosis, National
Cancer Institute (NCI), Executive Plaza North,
Room 344, 6130 Executive Boulevard,
Bethesda, MD 20892.
American Burkitt’s Lymphoma Registry,
Division of Cancer Etiology, National Cancer
Institute (NCI), Executive Plaza North, Suite 434,
6130 Executive Boulevard, Bethesda, MD 20892.
Chief, Genetic Epidemiology Branch,
Division of Cancer Epidemiology and
Genetics, National Cancer Institute (NCI),
Executive Plaza South, Room 7122, 6120
Executive Boulevard, Bethesda, MD 20892–
7236.
Program Director, Research Resources, Biological
Carcinogenesis Branch, Division of Cancer
Etiology, National Cancer Institute (NCI),
Executive Plaza North, Room 540, 6130
Executive Boulevard, Bethesda, MD 20892.

Chief, Environmental Epidemiology
Branch, Division of Cancer Etiology, National

Cancer Institute (NCI), Executive Plaza North,
Room 443, 6130 Executive Boulevard,
Bethesda, MD 20892.
Associate Director, Surveillance Program,
Division of Cancer Prevention, National
Cancer Institute (NCI), Executive Plaza North,
Room 343K, 6130 Executive Boulevard,
Bethesda, MD 20892.
Head, Biostatistics and Data Management
Section, Center for Cancer Research, National
Cancer Institute (NCI), Building 6116, Room 702,
6116 Executive Boulevard, Bethesda, MD 20892.

8C104,10 Center Drive, Bethesda, MD 20892–
1754.
Senior Scientific Advisor, Office of the
Director, Division of Epidemiology and
Clinical Applications, National Heart, Lung,
and Blood Institute (NHLBI), Federal
Building, Room 220, 7550 Wisconsin
Avenue, Bethesda, MD 20892.
Chief Laboratory of Epidemiology,
Demography and Biometry, National Institute on
Aging (NIA), Gateway Building, Room 3C309,
7201 Wisconsin Avenue, Bethesda, MD 20892.

Chief, Clinical Research Branch, Center for
Cancer Research, Frederick Cancer Research and
Development Center, National Cancer Institute
(NCI), 501 W. 7th Street, Room 3, Frederick, MD
21702.

Chief, Research Resources Branch,
Intramural Research Program, National
Institute on Aging (NIA), 5600 Nathan Shock
Drive, Baltimore, MD 21224.

Deputy Branch Chief, Navy Hospital, NCINaval
Medical Oncology Branch, Center for Cancer
Research, National Cancer Institute (NCI),
Building 8, Room 5101, Bethesda, MD 20814.

Chief, Pharmaceutical Management
Branch, Cancer Therapy Evaluation Program,
Division of Cancer Treatment and Diagnosis,
National Cancer Institute (NCI), Executive
Plaza North, Room 804, 6130 Executive
Boulevard, Bethesda, MD 20892.
Director, Extramural Clinical Studies,
Frederick Cancer Research and Development
Center, National Cancer Institute (NCI), Fort
Detrick, Frederick, MD 21702.
Clinical Operations Manager, National Eye
Institute (NEI), Building 10, Room 10S224, 10
Center Drive, Bethesda, MD 20892.
Director, Division of Biometry and Epidemiology,
National Eye Institute (NEI), Building 31, Room
6A52, 31 Center Drive, Bethesda, MD 20892.
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Associate Director, Office of Clinical
Affairs, National Heart, Lung, and Blood
Institute (NHLBI), Building 10, Room

Clinical Director, National Institute on
Aging (NIA), 5600 Nathan Shock Drive,
Baltimore, MD 21224.
Deputy Director, Division of Biometry and
Epidemiology, National Institute on Alcohol
Abuse and Alcoholism (NIAAA), Willco
Building, Room 514, 6000 Executive
Boulevard, Bethesda, MD 20892–7003.
Deputy Director, Division of Clinical and
Prevention Research, National Institute on
Alcohol Abuse and Alcoholism (NIAAA), Willco
Building, Room 505, 6000 Executive Boulevard,
Bethesda, MD 20892–7003.
Chief, Respiratory Viruses Section, Laboratory of
Infectious Diseases, National Institute of Allergy
and Infectious Diseases (NIAID), Building 7,
Room 106, 7 Memorial Drive, Bethesda, MD
20892.
Chief, Hepatitis Virus Section, Laboratory
of Infectious Diseases, National Institute of
Allergy and Infectious Diseases (NIAID),
Building 7, Room 202, 7 Memorial Drive,
Bethesda, MD 20892.
Chief, Biometry Branch, Division of
Microbiology and Infectious Diseases,
National Institute of Allergy and Infectious
Diseases (NIAID), 6700–B Rockledge Drive,
Room 3120, Bethesda, MD 20892.
Clinical Director, National Institute of
Arthritis and Musculoskeletal and Skin