Privacy Act of 1974; Report of a New System of Records; FDA Records Related to Research Misconduct Proceedings, 52036-52041 [2012-20888]
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Federal Register / Vol. 77, No. 167 / Tuesday, August 28, 2012 / Notices
FOR FURTHER INFORMATION CONTACT:
Beverly Friedman, Office of Regulatory
Policy, Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 51,
Rm. 6222, Silver Spring, MD 20993–
0002, 301–796–3602.
The Drug
Price Competition and Patent Term
Restoration Act of 1984 (Pub. L. 98–417)
and the Generic Animal Drug and Patent
Term Restoration Act (Pub. L. 100–670)
generally provide that a patent may be
extended for a period of up to 5 years
so long as the patented item (human
drug product, animal drug product,
medical device, food additive, or color
additive) was subject to regulatory
review by FDA before the item was
marketed. Under these acts, a product’s
regulatory review period forms the basis
for determining the amount of extension
an applicant may receive.
A regulatory review period consists of
two periods of time: A testing phase and
an approval phase. For human drug
products, the testing phase begins when
the exemption to permit the clinical
investigations of the drug becomes
effective and runs until the approval
phase begins. The approval phase starts
with the initial submission of an
application to market the human drug
product and continues until FDA grants
permission to market the drug product.
Although only a portion of a regulatory
review period may count toward the
actual amount of extension that the
Director of Patents and Trademarks may
award (for example, half the testing
phase must be subtracted as well as any
time that may have occurred before the
patent was issued), FDA’s determination
of the length of a regulatory review
period for a human drug product will
include all of the testing phase and
approval phase as specified in 35 U.S.C.
156(g)(1)(B).
FDA approved for marketing the
human drug product TORISEL
(temsirolimus). TORISEL is indicated
for the treatment of advanced renal cell
carcinoma. Subsequent to this approval,
the Patent and Trademark Office
received a patent term restoration
application for TORISEL (U.S. Patent
No. 5,362,718) from Wyeth, and the
Patent and Trademark Office requested
FDA’s assistance in determining this
patent’s eligibility for patent term
restoration and that FDA determine the
product’s regulatory review period. In a
letter dated August 7, 2012, FDA
advised the Patent and Trademark
Office that this human drug product had
undergone a regulatory review period
and that the approval of TORISEL
represented the first permitted
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SUPPLEMENTARY INFORMATION:
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commercial marketing or use of the
product.
FDA has determined that the
applicable regulatory review period for
TORISEL is 3,290 days. Of this time,
3,052 days occurred during the testing
phase of the regulatory review period,
while 238 days occurred during the
approval phase. These periods of time
were derived from the following dates:
1. The date an exemption under
section 505(i) of the Federal Food, Drug,
and Cosmetic Act (the FD&C Act) (21
U.S.C. 355(i)) became effective: May 29,
1998. FDA has verified the applicant’s
claim that the date the investigational
new drug application became effective
was on May 29, 1998.
2. The date the application was
initially submitted with respect to the
human drug product under section
505(b) of the FD&C Act: October 5, 2006.
FDA has verified the applicant’s claim
that the new drug application (NDA) for
TORISEL (NDA 22–088) was submitted
on October 5, 2006.
3. The date the application was
approved: May 30, 2007. FDA has
verified the applicant’s claim that NDA
22–088 was approved on May 30, 2007.
This determination of the regulatory
review period establishes the maximum
potential length of a patent extension.
However, the U.S. Patent and
Trademark Office applies several
statutory limitations in its calculations
of the actual period for patent extension.
In its application for patent extension,
this applicant seeks 1,764 days of patent
term extension.
Anyone with knowledge that any of
the dates as published are incorrect may
submit to the Division of Dockets
Management (see ADDRESSES) either
electronic or written comments and ask
for a redetermination by October 29,
2012. Furthermore, any interested
person may petition FDA for a
determination regarding whether the
applicant for extension acted with due
diligence during the regulatory review
period by February 25, 2013. To meet its
burden, the petition must contain
sufficient facts to merit an FDA
investigation. (See H. Rept. 857, part 1,
98th Cong., 2d sess., pp. 41–42, 1984.)
Petitions should be in the format
specified in 21 CFR 10.30.
Interested persons may submit to the
Division of Dockets Management (see
ADDRESSES) electronic or written
comments and written petitions. It is
only necessary to send one set of
comments. It is no longer necessary to
send three copies of mailed comments.
However, if you submit a written
petition, you must submit three copies
of the petition. Identify comments with
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the docket number found in brackets in
the heading of this document.
Comments and petitions that have not
been made publicly available on https://
www.regulations.gov may be viewed in
the Division of Dockets Management
between 9 a.m. and 4 p.m., Monday
through Friday.
Dated: August 12, 2012.
Jane A. Axelrad,
Associate Director for Policy, Center for Drug
Evaluation and Research.
[FR Doc. 2012–21239 Filed 8–27–12; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–N–0253]
Privacy Act of 1974; Report of a New
System of Records; FDA Records
Related to Research Misconduct
Proceedings
AGENCY:
Food and Drug Administration,
HHS.
Notice of a Privacy Act system
of records.
ACTION:
In accordance with the
requirements of the Privacy Act of 1974
(the Privacy Act) and the Food and Drug
Administration’s (FDA’s) regulations for
the protection of privacy, FDA is
publishing notice of a new Privacy Act
system of records entitled ‘‘FDA
Records Related to Research Misconduct
Proceedings, HHS/FDA/OC’’ System No.
09–10–0020. Under the Department of
Health and Human Services’ (HHS’ or
the Department’s) Public Health Service
Policies on Research Misconduct, FDA
has responsibilities for addressing
research integrity and misconduct
issues related to FDA supported
activities. This system contains records
related to the processing and reviewing
of allegations of scientific research
misconduct levied against an individual
(the respondent) who is an agent of, or
affiliated by contract or agreement with,
FDA, or an FDA employee involved in
intramural research. Research
misconduct proceedings include
allegation assessments, inquiries,
investigations, oversight reviews by
HHS’ Office of Research Integrity (ORI),
hearings, and administrative appeals.
DATES: Effective Date: The new system
of records will be effective on August
28, 2012, with the exception of the
routine uses and the requested
exemptions. The routine uses will
become effective on October 12, 2012.
As detailed in the companion
SUMMARY:
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rulemaking documents published
elsewhere in this issue of the Federal
Register, unless revised or withdrawn in
response to comments, the requested
exemptions will become effective 135
days after publication of the companion
rulemaking documents. Submit either
electronic or written comments
regarding this document by October 12,
2012.
You may submit comments,
identified by Docket No. FDA–2011–N–
0253, by any of the following methods:
ADDRESSES:
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal: https://
www.regulations.gov. Follow the
instructions for submitting comments.
Written Submissions
Submit written submissions in the
following ways:
• FAX: 301–827–6870.
• Mail/Hand delivery/Courier (for
paper or CD–ROM submissions):
Division of Dockets Management (HFA–
305), Food and Drug Administration,
5630 Fishers Lane, Rm. 1061, Rockville,
MD 20852.
Instructions: All submissions received
must include the Agency name and
docket number for this document. All
comments received may be posted
without change to https://
www.regulations.gov, including any
personal information provided. For
additional information on submitting
comments, see the ‘‘Comments’’ heading
of the SUPPLEMENTARY INFORMATION
section of this document.
Docket: For access to the docket to
read background documents or
comments received, go to https://
www.regulations.gov and insert the
docket number, found in brackets in the
heading of this document, into the
‘‘Search’’ box and follow the prompts
and/or go to the Division of Dockets
Management, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT:
Eileen Parish, Office of the Chief
Scientist, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 32, Rm. 4214, Silver Spring,
MD 20993, 301–796–8522,
Eileen.Parish@fda.hhs.gov.
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SUPPLEMENTARY INFORMATION:
I. New System of Records
A. Description of the System of Records
1. Collection and Maintenance of Data
in the System
This system will collect and maintain
personally identifiable information (PII)
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and other data collected during the
research misconduct process. The
collected information will include, but
is not limited to: Name, address,
telephone number, education,
professional experience, employment
address, and training of an individual(s)
who is (are) the subject of allegations. In
addition, the system will contain
records of complaints received,
including the identity of the
complainant, and how complaints were
received and resolved. Also included
will be information of witnesses and
members of research misconduct
committees.
2. Agency Procedures
FDA’s procedures for disclosures of
information maintained in this system
of records are set forth in 21 CFR part
21.
B. Routine Use Disclosures of
Information in the System
In accordance with the Privacy Act (5
U.S.C. 552a), FDA is providing notice of
the ‘‘routine uses’’ of the records
contained in the system of records.
Disclosure of such records is permitted
without the written consent of the
individual to whom the record pertains,
if the information is to be used for a
purpose that is compatible with the
purpose(s) for which the information
was collected (5 U.S.C. 552a(b)(3)). Any
such compatible use of data is known as
a ‘‘routine use.’’ The routine uses in this
system meet the compatibility
requirement of the Privacy Act.
The first two routine uses permit FDA
to share information from this system
with the individual or entity submitting
an allegation; witnesses; pertinent
Federal, State, and local agencies; and
third parties that can provide
information related to the allegation or
proceeding.
In the event of a suspected or
confirmed breach of security or
confidentiality of the system, the third
routine use allows disclosures to
Federal Agencies as necessary in order
to respond to the breach. Likewise,
where a record indicates a violation of
law, FDA may share information with
the responsible enforcement authority
under the fifth routine use, and may
provide information to the Department
of Homeland Security (DHS) in
circumstances where system records are
captured in an intrusion detection
program and made accessible to DHS as
described in routine use 15.
When health implications are evident
based on information developed in the
course of a proceeding, the fourth
routine use permits disclosure to
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research subjects, institutional review
boards, and collaborating institutions.
When FDA finds research misconduct
has occurred, routine uses 6 through 10
describe disclosures FDA may make to
FDA supported entities (routine use 6),
to the respondent’s supervisor or
employer (routine use 7 and 8), to
publications as needed to retract
research results (routine use 9), and
licensing authorities (routine use 10).
Similarly, routine use 12 permits
disclosure of information to the parties
and related institutions when FDA does
not find research misconduct.
Additional routine uses common to
Federal records systems provide for
disclosure to contractors and others who
perform services for FDA related to this
system (routine use 11), to the
Department of Justice (DOJ) as related to
the DOJ’s representation of FDA or
Agency employees (routine use 13), to
courts when the records are relevant in
legal actions involving the U.S.
Government, FDA, or Agency
employees (routine use 14), and, to the
National Archives and Records
Administration and General Services
Administration as needed in the course
of records management inspections
(routine use 16).
As specified in section I.K of this
document (see Routine Uses of Records
Maintained in the System Including the
Purposes of Such Uses and Categories of
Users), many of these routine use
disclosures will be restricted and
subject to confidentiality or similar
nondisclosure agreements in order to
protect privacy.
Because this is a law enforcement
investigatory system, HHS and FDA
intend to amend their Privacy Act
regulations (45 CFR 5b.11 and 21 CFR
21.61, respectively) to exempt records in
this system related to ongoing
investigations or that would reveal a
confidential source from the
notification, access, and amendments
provisions of the Privacy Act. These
exemptions are necessary to maintain
the integrity of research misconduct
proceedings and allow FDA to obtain
essential information. The proposed
exemptions would ensure that the
records related to ongoing investigations
will not be disclosed inappropriately
and that the identities of confidential
sources will be protected. FDA and HHS
are publishing companion rulemaking
documents regarding these exemptions
elsewhere in this issue of the Federal
Register.
C. System Number
The system number is: 09–10–0020.
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programs; (4) FDA supported extramural
or intramural activities that are related
to biomedical or behavioral research or
research training; and (5) plagiarism of
research records produced in the course
of FDA supported research, research
training, or activities related to that
research or research training.
D. System Name
The system name is: FDA Records
Related to Research Misconduct
Proceedings, HHS/FDA/OC.
E. Security Classification
The security classification for the
system is: Unclassified.
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F. System Location
System records are located in the
Office of the Chief Scientist, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 32, rm. 4214,
Silver Spring, MD 20993. Some records
may reside in the Agency component
offices during the time that an allegation
is under review.
G. Categories of Individuals Covered by
the System
This system includes records related
to the processing and reviewing of
allegations of research misconduct
levied against an individual (the
respondent) who is an agent of, or
affiliated by contract or agreement with
FDA, or an FDA employee involved in
intramural research. The records
contain personally identifiable
information (PII) and non-PII about
respondents, complainants, witnesses
and other individuals affiliated with
entities that are contacted by or provide
information to FDA.
Privacy Act notification, access, and
amendment rights (described in this
document) relative to this system are
available to individuals who are
subjects of records in the system, that is,
respondents. Although records in the
system may contain PII related to other
individuals, only respondents are
considered subjects of records in this
system.
‘‘Respondents’’ is defined as ‘‘the
person against whom an allegation of
research misconduct is directed or who
is the subject of a research misconduct
proceeding.’’ The term ‘‘research
misconduct’’ is defined in 42 CFR
93.103 to mean ‘‘fabrication,
falsification, or plagiarism in proposing,
performing, or reviewing research, or in
reporting research results.’’ These and
other definitions are set out in 42 CFR
part 93.
This system notice applies to an
allegation of research misconduct
involving the following: (1)
Applications or proposals for FDA
support for biomedical or behavioral
extramural or intramural research or
research training, or activities related to
that research or research training; (2)
FDA supported biomedical or
behavioral extramural or intramural
research; (3) FDA supported extramural
or intramural research training
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findings of research misconduct and
final decisions regarding administrative
actions and their implementation; and
(4) FDA and ORI coordination with
other Federal, State, and local offices or
agencies, including the DOJ.
H. Categories of Records in the System
The records in the system include
information that must be submitted to
ORI by FDA under 42 CFR part 93 and
information that FDA obtains while
conducting research misconduct
proceedings. This information may
include, but is not limited to:
• PII about respondents such as
name, date of birth, employment
information, educational background,
social security number, personal and
professional phone numbers, mailing
address, and email address;
• PII regarding complainants and
witnesses such as name, and personal or
work contact information;
• The nature and substance of
allegations;
• Data regarding FDA funding related
to the research and/or respondent,
including grants numbers;
• The organization(s) and officials
responsible for conducting the action
that are part of the research misconduct
proceeding;
• The documentation used in the
inquiry and investigation, including
relevant research data and materials,
which may include relevant information
on study subjects;
• Applications, proposals, and
documentation related to review and
award actions;
• Reports, abstracts, manuscripts, and
publications by the respondent(s);
• Other relevant reports, abstracts,
manuscripts, and publications;
• Correspondence and memoranda of
telephone calls;
• Summaries of interviews and
transcripts or recordings of interviews;
• Statistical, scientific, and forensic
analyses;
• Interim and final FDA reports; and
• Records of Agency findings,
administrative actions, and appeal
proceedings, if any.
The system also contains general
administrative and oversight records
regarding ORI actions. This includes
information related to the following: (1)
ORI reviews of the research misconduct
proceedings, ORI findings of research
misconduct, and ORI proposals for
administrative action or for settlement
of the case; (2) a respondent’s
opportunity to contest ORI findings of
research misconduct and proposed HHS
administrative actions; (3) final HHS
The authorities for maintaining this
system are: 21 U.S.C. 371, 375,
393(d)(2), 394, 397, and 399a; 42 U.S.C.
216(b), 241, 289b; 5 U.S.C. 301; 44
U.S.C. 3101; and 42 CFR part 93.
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I. Authority for Maintenance of the
System
J. Purpose
The purposes of this system are to do
the following:
1. Enable FDA, ORI, HHS, and the
Federal Government to protect the
health and safety of the public, to
promote the integrity of FDA supported
research, and to conserve public funds.
2. Enable FDA to implement its
authority relating to research
misconduct proceedings as set forth in
42 CFR part 93 and to document FDA
activities in implementing that
authority.
3. Ensure that research misconduct
proceedings, including FDA’s
implementation of the Agency’s and
other HHS administrative actions, are
carried out in accordance with FDA
policy, 42 CFR part 93, and other
applicable Federal statutes and
regulations.
4. Enable FDA to inform Agency
officials and other HHS officials who
have a need for the records in the
performance of their duties of the status
and results of research misconduct
proceedings.
5. Enable FDA to notify, consult with,
and provide assistance to ORI, and other
Federal, State, or local agencies to
permit them to take action to protect the
health and safety of the public, to
promote the integrity of FDA supported
research, to conserve public funds, or to
pursue potential violations of civil and
criminal statutes.
K. Routine Uses of Records Maintained
in the System Including the Purposes of
Such Uses and Categories of Users
The Privacy Act lists the conditions
for disclosure under 5 U.S.C. 552a(b).
Among the permitted disclosures is
disclosure ‘‘to those officers and
employees of the agency which
maintains the record who have a need
for the record in the performance of
their duties’’ (5 U.S.C. 552a(b)(1)). For
this system of records, this condition
would include disclosure to the
appropriate FDA, ORI, and other HHS
officers and employees.
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Permitted disclosures also include
routine uses that are listed in the notice
of the system of records (5 U.S.C.
552a(b)(3)). The Privacy Act defines
‘‘routine use’’ as ‘‘with respect to the
disclosure of a record, the use of such
record for a purpose which is
compatible with the purpose for which
it was collected.’’ See also FDA’s
Privacy Act regulations, defining
‘‘routine use’’ as ‘‘use outside the
Department of Health and Human
Services that is compatible with the
purpose for which the records were
collected and described in the [System
of Records] notice)’’ (21 CFR
21.20(b)(5)).
Records in this system that contain
information about record subjects
(respondents) and nonsubjects
(witnesses, complainants, and other
individuals affiliated with entities that
are contacted by or provide information
to FDA) may be disclosed to recipients
outside HHS in accordance with the
following routine uses:
1. Disclosure may be made to any
individual or entity able to obtain
information or provide information or
assistance in a research misconduct
proceeding or related proceeding.
Recipients of disclosures under this
routine use may include experts asked
to perform statistical, forensic, or other
analyses; the relevant FDA supported
institution(s); institutions with which
the respondent(s) was previously
affiliated; Federal, State and local
agencies; the respondent(s); the
complainant(s); witnesses; and
organizations or individuals acting on
behalf of those agencies, institutions,
and individuals; provided, however,
that in each case FDA determines
whether limited disclosures or
confidentiality agreements are needed to
protect the privacy of respondent(s),
complainant(s), witnesses, research
subjects, or others who may be
identified in the records to be disclosed.
2. Disclosure may be made to other
Federal, State, or local agencies and
offices, if FDA has reason to believe that
a research misconduct proceeding may
involve that agency or office.
3. Disclosure may be made to
appropriate Federal Agencies and
Department contractors that have a need
to know the information for the purpose
of assisting the Department’s efforts to
respond to a suspected or confirmed
breach of the security or confidentiality
of information maintained in this
system of records, and the information
disclosed is relevant and necessary for
that assistance.
4. Disclosure may be made to
Institutional Review Boards,
collaborating institutions, and
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individual research subjects, regarding
information obtained or developed
through a research misconduct
proceeding that, in FDA’s judgment,
may have implications for individuals’
health or for their participation in a
research study.
5. When a record on its face, or in
conjunction with other records,
indicates a violation or potential
violation of law, whether civil, criminal,
or regulatory in nature, disclosure may
be made to the appropriate agency,
whether Federal, foreign, State, local, or
tribal, or other public authority
responsible for enforcing, investigating,
or prosecuting such violation, if the
information disclosed is relevant to the
responsibilities of the agency or public
authority.
6. After FDA makes a finding of
research misconduct and has informed
ORI of this finding, disclosure may be
made to responsible officials of FDA
supported institutions or organizations,
when in connection with a research
misconduct proceeding concerning a
respondent previously or currently
employed by, or affiliated with the
institution or organization, or when
FDA, ORI, or HHS makes a finding or
takes an action potentially affecting the
agency or organization or its FDA
support for research, research training,
or related activities.
7. After FDA makes a finding of
research misconduct and has informed
ORI of this finding, disclosure may be
made to the respondent’s supervisor
because research will be a significant
part of many employee jobs, and
performance is an important element of
information to help the supervisor
determine employee assignments as
well as the level of supervision needed.
If an individual moves to another job or
contract, FDA may notify the other
entity that we have relevant information
with regard to that individual.
8. After FDA makes a finding of
research misconduct and has informed
ORI of this finding, disclosure may be
made to a Federal Agency in connection
with the hiring or retention of the
respondent, the issuance of a security
clearance, the reporting of an
investigation of an employee, or the
issuance of a license or other benefit by
the Agency, to the extent that the record
is relevant to the Agency’s decision on
the matter.
9. After FDA makes a finding of
research misconduct and has informed
ORI of this finding, disclosure may be
made to professional journals, other
publications, news media, and the
public concerning research misconduct
findings and the need to correct or
retract research results or reports that
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have been affected by research
misconduct, unless it is determined that
release of the specific information in the
context of a particular case would
constitute a clearly unwarranted
invasion of personal privacy. No
information will be released that would
reveal a confidential source.
10. After FDA makes a finding of
research misconduct and has informed
ORI of this finding, disclosure may be
made to a State licensing board,
certifying body, or other similar entity
conducting a review of the respondent
to aid the entity in meeting its
responsibility to protect the health of
the population in its jurisdiction or the
integrity of the profession.
11. Disclosure may be made to
contractors and other individuals or
entities who perform services for the
Agency related to this system of records
and who have access to the records in
order to perform such services,
including individuals appointed to
serve on FDA research misconduct
inquiry committees or investigation
committees if such individuals need
access to the records to perform their
assigned task. Provided, however, in
each case FDA determines whether
limited disclosures or confidentiality
agreements are needed to protect the
privacy of respondent(s),
complainants(s), witnesses, research
subjects, or others who may be
identified in the records to be disclosed;
and FDA determines that the disclosure
is for a purpose compatible with the
purpose for which the Agency collected
the records.
12. When FDA closes a case without
a settlement or finding of research
misconduct, disclosure may be made to
the respondent, relevant institution, and
complainant(s); provided, however, that
in each case FDA determines whether
limited disclosures or confidentiality
agreements are needed to protect the
privacy of respondent(s),
complainant(s), witnesses, research
subjects, or others who may be
identified in the records to be disclosed.
13. Disclosure may be made to the
DOJ when: (1) The Agency or any
component thereof; or (2) any employee
of the Agency in his or her official
capacity; or (3) any employee of the
Agency in his or her individual capacity
where the DOJ has agreed to represent
the employee; or (4) the U.S.
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 DOJ is therefore
deemed by the Agency to be for a
purpose that is compatible with the
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purpose for which the Agency collected
the records.
14. Disclosure may be made to a court
or other tribunal when: (1) The Agency
or any component thereof; or (2) any
employee of the Agency in his or her
official capacity; or (3) any employee of
the Agency in his or her individual
capacity where the DOJ has agreed to
represent the employee; or (4) the U.S.
Government is a party to the proceeding
or has an interest in such proceeding,
and by careful review, the Agency
determines that the records are both
relevant and necessary to the
proceeding and the use of such records
is therefore deemed by the Agency to be
for a purpose that is compatible with the
purpose for which the Agency collected
the records.
15. Einstein 2 Cyber Security
Monitoring: Records may become
accessible to U.S. Department of
Homeland Security (DHS) cyber security
personnel, if captured in an intrusion
detection system used by HHS and DHS
pursuant to the Einstein 2 program.
Under Einstein 2, DHS uses intrusion
detection systems to monitor Internet
traffic to and from federal computer
networks to prevent malicious computer
code from reaching the networks.
According to DHS’ Privacy Impact
Assessment for Einstein 2 (available on
the DHS Cybersecurity privacy Web site,
https://www.dhs.gov), only PII that is
directly related to a malicious code
security incident is captured by and
accessible to DHS, and DHS does not
access PII unless the PII is part of the
malicious code.
16. Disclosure may be made to the
National Archives and Records
Administration and/or the General
Services Administration for the purpose
of records management inspections
conducted under authority of 44 U.S.C.
2904 and 2906.
L. Policies and Practices for Storing,
Retrieving, Accessing, Retaining, and
Disposing of Records in the System
1. Storage
Records may be maintained in hard
copy files and on computer disks, hard
drive, and file servers, and other types
of data storage devices.
srobinson on DSK4SPTVN1PROD with NOTICES
2. Retrievability
Agency’s Chief Scientist and Deputy
Commissioner for Science and Public
Health, the Agency’s Research Integrity
Officer (System Manager), and to other
appropriate FDA staff when they have a
need for the records in the performance
of their duties. Records are also
available to the Director of ORI and
other appropriate ORI staff, and to other
appropriate HHS officials that are
involved in the research misconduct
proceeding, when there is a need to
know in the performance of their duties.
All authorized users are informed that
the records are confidential and are not
to be further disclosed.
b. Procedural safeguards. Access is
strictly controlled by the Research
Integrity Officer (System Manager) in
compliance with the Privacy Act and
this system notice. Access to the records
is limited to ensure confidentiality. All
questions and inquiries from any party
should be addressed to the Research
Integrity Officer (System Manager).
c. Physical safeguards. All records
(such as diskettes, computer listings, or
documents) are kept in a secured area,
locked rooms, and locked building. The
facility has a 24-hour guard service, and
access to the building is further
controlled by an operational card key
system. Access to the files, which are
generally hard copy, is limited to a
subset of individuals with general
access to the building.
Access to individual offices is
controlled by simplex locks. Records are
kept in locked file cabinets in a room
that is locked during non-working
hours. Access to this room is restricted
to specific personnel. Access to
computer files is strictly limited through
passwords and user-invisible
encryption. Special measures
commensurate with the sensitivity of
the record are taken to prevent
unauthorized copying or disclosure of
the records.
M. Retention and Disposal
The records are maintained for 7 years
in accordance with 42 CFR part 93,
FDA’s Records Control Schedule, and
with the applicable General Records
Schedule and disposition schedule
approved by the National Archives and
Records Administration.
3. Safeguards
N. System Manager and Address
FDA Research Integrity Officer, Office
of the Chief Scientist, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 32, Rm. 4214, Silver Spring,
MD 20993.
a. Authorized users. Records in FDA’s
system are available to the
Commissioner of Food and Drugs, the
O. Notification Procedure
In accordance with 21 CFR part 21,
subpart D, an individual may find out
Records may be retrieved by manual
or computer search of the case-tracking
system using the name of the
respondent(s).
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16:39 Aug 27, 2012
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whether a record exists about him or her
by submitting a written request, with
notarized signature if request is made by
mail, or with identification if request is
made in person, directed to: FDA
Privacy Act Coordinator, Division of
Freedom of Information (ELEM–1029),
Food and Drug Administration, 12420
Parklawn Dr., Element Building,
Rockville, MD 20857. HHS/FDA is
exempting all records related to research
misconduct proceedings from this
provision (see section I.S of this
document Records Exempted from
Certain Provisions of the Privacy Act).
However, consideration will be given to
requests addressed to the Privacy Act
Coordinator as described previously in
this document. In addition, some
records may be exempt under 5 U.S.C
552a(d)(5), if they are ‘‘compiled in
reasonable anticipation of a civil action
or proceeding.’’ See also 21 CFR
21.41(e).
P. Record Access Procedures
Procedures are the same as those in
section I.O of this document
(Notification Procedure). Requests
should also reasonably specify the
record contents being sought and may
also request an accounting of
disclosures that have been made of the
record, if any. As stated previously in
this document, HHS/FDA is exempting
all records related to research
misconduct proceedings from this
provision (see section I.S of this
document, Records Exempted from
Certain Provisions of the Privacy Act),
and some records may be exempt under
5 U.S.C. 552a(d)(5). However,
consideration will be given to access
requests addressed to the Privacy Act
Coordinator as described in section I.O
of this document (Notification
Procedure).
Q. Contesting Record Procedures
In accordance with 21 CFR 21.50,
contact the Privacy Act Coordinator,
Food and Drug Administration (see FOR
FURTHER INFORMATION CONTACT or
section I.O of this document).
Reasonably identify the record and
specify the information being contested,
the corrective action sought, and your
reasons for requesting the correction,
along with supporting information to
show how the record is inaccurate,
incomplete, untimely, or irrelevant. As
stated previously in this document,
HHS/FDA is exempting all records
related to research misconduct
proceedings from this provision (see
section I.S of this document, Records
Exempted from Certain Provisions of the
Privacy Act), and some records may be
exempt under 5 U.S.C. 552a(d)(5).
E:\FR\FM\28AUN1.SGM
28AUN1
Federal Register / Vol. 77, No. 167 / Tuesday, August 28, 2012 / Notices
R. Record Source Categories
Information in this system is obtained
from many sources, including the
following: (1) Directly from the
respondent or complainant or his/her
representative; (2) derived from
materials supplied by the respondent or
complainant or his/her representative;
(3) from information supplied by the
institutions, witnesses, scientific
publications, and other
nongovernmental sources; (4) from
observation and analysis made by FDA
and ORI staff and scientific experts; (5)
from departmental and other Federal,
State, and local government records; (6)
from hearings and other administrative
proceedings; and (7) from any other
relevant source.
srobinson on DSK4SPTVN1PROD with NOTICES
S. Records Exempted From Certain
Provisions of the Privacy Act
FDA records related to research
misconduct proceedings will be exempt
from the Privacy Act requirements
pertaining to providing an accounting of
disclosures, access and amendment,
notification, and Agency procedures
and rules under sections 552a(k)(2) and
(k)(5) of the Privacy Act.
Elsewhere in this issue of the Federal
Register, FDA is publishing a notice of
proposed rulemaking and direct final
rule to apply these exemptions to
records in this system related to ongoing
investigations or that would reveal a
confidential source. These exemptions
are necessary to safeguard the integrity
of the research misconduct proceedings
and to ensure that FDA’s efforts to
obtain accurate and objective
information will not be hindered. In the
course of investigations of allegations of
research misconduct, it is often
necessary to give an express promise to
withhold the identity of an individual
who has provided relevant information.
Sources of information necessary to
complete an effective investigation may
be reluctant to provide sensitive
information unless they can be assured
that their identities will not be revealed.
The proposed exemptions will ensure
that the records related to ongoing
investigations will not be disclosed
inappropriately and that the identities
of confidential sources will be
protected.
The notice of proposed rulemaking
and direct final rule provide additional
detail regarding the bases for these
exemptions.
II. Comments
FDA invites comments on all parts of
the systems notice. Interested persons
may submit to the Division of Dockets
Management (see ADDRESSES) either
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electronic or written comments
regarding this document. It is only
necessary to send one set of comments.
Identify comments with the docket
number found in brackets in the
heading of this document. Received
comments may be seen in the Division
of Dockets Management between 9 a.m.
and 4 p.m., Monday through Friday.
Dated: June 12, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012–20888 Filed 8–27–12; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Advisory Commission on Childhood
Vaccines, Notice of Meeting
In accordance with section 10(a)(2) of
the Federal Advisory Committee Act
(Pub. L. 92–463), notice is hereby given
of the following meeting:
Name: Advisory Commission on
Childhood Vaccines (ACCV).
Date and Time: September 06, 2012,
1:00 p.m. to 5:15 p.m. EDT.
Place: Parklawn Building (and via
audio conference call), Conference
Room 10–65, 5600 Fishers Lane,
Rockville, MD 20857.
The ACCV will meet on Thursday,
September 06 from 1:00 p.m. to 5:15
p.m. (EDT). The public can join the
meeting via audio conference call by
dialing 1–800–369–3104 on September
06, and providing the following
information:
Leader’s Name: Dr. Geoffrey Evans
Password: ACCV
Agenda: The agenda items for the
September meeting will include, but are
not limited to: Updates from the
Division of Vaccine Injury
Compensation (DVIC), Department of
Justice (DOJ), National Vaccine Program
Office (NVPO), Immunization Safety
Office (Centers for Disease Control and
Prevention), National Institute of
Allergy and Infectious Diseases
(National Institutes of Health) and
Center for Biologics Evaluation and
Research (Food and Drug
Administration). A draft agenda and
additional meeting materials will be
posted on the ACCV web site (https://
www.hrsa.gov/vaccinecompensation/
accv.htm) prior to the meeting. Agenda
items are subject to change as priorities
dictate.
Public Comment: Persons interested
in attending the meeting in person or
providing an oral presentation should
PO 00000
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Fmt 4703
Sfmt 4703
52041
submit a written request, along with a
copy of their presentation to: Annie
Herzog, DVIC, Healthcare Systems
Bureau (HSB), Health Resources and
Services Administration (HRSA), Room
11C–26, 5600 Fishers Lane, Rockville,
Maryland 20857 or email:
aherzog@hrsa.gov. Requests should
contain the name, address, telephone
number, email address, and any
business or professional affiliation of
the person desiring to make an oral
presentation. Groups having similar
interests are requested to combine their
comments and present them through a
single representative. The allocation of
time may be adjusted to accommodate
the level of expressed interest. DVIC
will notify each presenter by email,
mail, or telephone of their assigned
presentation time. Persons who do not
file an advance request for a
presentation, but desire to make an oral
statement, may announce it at the time
of the public comment period. Public
participation and ability to comment
will be limited to space and time as
available.
FOR FURTHER INFORMATION CONTACT:
Anyone requiring information regarding
the ACCV should contact Annie Herzog,
DVIC, HSB, HRSA, Room 11C–26, 5600
Fishers Lane, Rockville, MD 20857;
telephone (301) 443–6593, or email:
aherzog@hrsa.gov.
Dated: August 22, 2012.
Bahar Niakan,
Director, Division of Policy and Information
Coordination.
[FR Doc. 2012–21093 Filed 8–27–12; 8:45 am]
BILLING CODE 4165–15–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Allergy and
Infectious Diseases; Notice of Closed
Meetings
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of the following meetings.
The meetings will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
E:\FR\FM\28AUN1.SGM
28AUN1
]]>Agencies
[Federal Register Volume 77, Number 167 (Tuesday, August 28, 2012)]
[Notices]
[Pages 52036-52041]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-20888]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2011-N-0253]
Privacy Act of 1974; Report of a New System of Records; FDA
Records Related to Research Misconduct Proceedings
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of a Privacy Act system of records.
-----------------------------------------------------------------------
SUMMARY: In accordance with the requirements of the Privacy Act of 1974
(the Privacy Act) and the Food and Drug Administration's (FDA's)
regulations for the protection of privacy, FDA is publishing notice of
a new Privacy Act system of records entitled ``FDA Records Related to
Research Misconduct Proceedings, HHS/FDA/OC'' System No. 09-10-0020.
Under the Department of Health and Human Services' (HHS' or the
Department's) Public Health Service Policies on Research Misconduct,
FDA has responsibilities for addressing research integrity and
misconduct issues related to FDA supported activities. This system
contains records related to the processing and reviewing of allegations
of scientific research misconduct levied against an individual (the
respondent) who is an agent of, or affiliated by contract or agreement
with, FDA, or an FDA employee involved in intramural research. Research
misconduct proceedings include allegation assessments, inquiries,
investigations, oversight reviews by HHS' Office of Research Integrity
(ORI), hearings, and administrative appeals.
DATES: Effective Date: The new system of records will be effective on
August 28, 2012, with the exception of the routine uses and the
requested exemptions. The routine uses will become effective on October
12, 2012. As detailed in the companion
[[Page 52037]]
rulemaking documents published elsewhere in this issue of the Federal
Register, unless revised or withdrawn in response to comments, the
requested exemptions will become effective 135 days after publication
of the companion rulemaking documents. Submit either electronic or
written comments regarding this document by October 12, 2012.
ADDRESSES: You may submit comments, identified by Docket No. FDA-2011-
N-0253, by any of the following methods:
Electronic Submissions
Submit electronic comments in the following way:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments.
Written Submissions
Submit written submissions in the following ways:
FAX: 301-827-6870.
Mail/Hand delivery/Courier (for paper or CD-ROM
submissions): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
Instructions: All submissions received must include the Agency name
and docket number for this document. All comments received may be
posted without change to https://www.regulations.gov, including any
personal information provided. For additional information on submitting
comments, see the ``Comments'' heading of the SUPPLEMENTARY INFORMATION
section of this document.
Docket: For access to the docket to read background documents or
comments received, go to https://www.regulations.gov and insert the
docket number, found in brackets in the heading of this document, into
the ``Search'' box and follow the prompts and/or go to the Division of
Dockets Management, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Eileen Parish, Office of the Chief
Scientist, Food and Drug Administration, 10903 New Hampshire Ave.,
Bldg. 32, Rm. 4214, Silver Spring, MD 20993, 301-796-8522,
Eileen.Parish@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. New System of Records
A. Description of the System of Records
1. Collection and Maintenance of Data in the System
This system will collect and maintain personally identifiable
information (PII) and other data collected during the research
misconduct process. The collected information will include, but is not
limited to: Name, address, telephone number, education, professional
experience, employment address, and training of an individual(s) who is
(are) the subject of allegations. In addition, the system will contain
records of complaints received, including the identity of the
complainant, and how complaints were received and resolved. Also
included will be information of witnesses and members of research
misconduct committees.
2. Agency Procedures
FDA's procedures for disclosures of information maintained in this
system of records are set forth in 21 CFR part 21.
B. Routine Use Disclosures of Information in the System
In accordance with the Privacy Act (5 U.S.C. 552a), FDA is
providing notice of the ``routine uses'' of the records contained in
the system of records. Disclosure of such records is permitted without
the written consent of the individual to whom the record pertains, if
the information is to be used for a purpose that is compatible with the
purpose(s) for which the information was collected (5 U.S.C.
552a(b)(3)). Any such compatible use of data is known as a ``routine
use.'' The routine uses in this system meet the compatibility
requirement of the Privacy Act.
The first two routine uses permit FDA to share information from
this system with the individual or entity submitting an allegation;
witnesses; pertinent Federal, State, and local agencies; and third
parties that can provide information related to the allegation or
proceeding.
In the event of a suspected or confirmed breach of security or
confidentiality of the system, the third routine use allows disclosures
to Federal Agencies as necessary in order to respond to the breach.
Likewise, where a record indicates a violation of law, FDA may share
information with the responsible enforcement authority under the fifth
routine use, and may provide information to the Department of Homeland
Security (DHS) in circumstances where system records are captured in an
intrusion detection program and made accessible to DHS as described in
routine use 15.
When health implications are evident based on information developed
in the course of a proceeding, the fourth routine use permits
disclosure to research subjects, institutional review boards, and
collaborating institutions.
When FDA finds research misconduct has occurred, routine uses 6
through 10 describe disclosures FDA may make to FDA supported entities
(routine use 6), to the respondent's supervisor or employer (routine
use 7 and 8), to publications as needed to retract research results
(routine use 9), and licensing authorities (routine use 10). Similarly,
routine use 12 permits disclosure of information to the parties and
related institutions when FDA does not find research misconduct.
Additional routine uses common to Federal records systems provide
for disclosure to contractors and others who perform services for FDA
related to this system (routine use 11), to the Department of Justice
(DOJ) as related to the DOJ's representation of FDA or Agency employees
(routine use 13), to courts when the records are relevant in legal
actions involving the U.S. Government, FDA, or Agency employees
(routine use 14), and, to the National Archives and Records
Administration and General Services Administration as needed in the
course of records management inspections (routine use 16).
As specified in section I.K of this document (see Routine Uses of
Records Maintained in the System Including the Purposes of Such Uses
and Categories of Users), many of these routine use disclosures will be
restricted and subject to confidentiality or similar nondisclosure
agreements in order to protect privacy.
Because this is a law enforcement investigatory system, HHS and FDA
intend to amend their Privacy Act regulations (45 CFR 5b.11 and 21 CFR
21.61, respectively) to exempt records in this system related to
ongoing investigations or that would reveal a confidential source from
the notification, access, and amendments provisions of the Privacy Act.
These exemptions are necessary to maintain the integrity of research
misconduct proceedings and allow FDA to obtain essential information.
The proposed exemptions would ensure that the records related to
ongoing investigations will not be disclosed inappropriately and that
the identities of confidential sources will be protected. FDA and HHS
are publishing companion rulemaking documents regarding these
exemptions elsewhere in this issue of the Federal Register.
C. System Number
The system number is: 09-10-0020.
[[Page 52038]]
D. System Name
The system name is: FDA Records Related to Research Misconduct
Proceedings, HHS/FDA/OC.
E. Security Classification
The security classification for the system is: Unclassified.
F. System Location
System records are located in the Office of the Chief Scientist,
Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, rm.
4214, Silver Spring, MD 20993. Some records may reside in the Agency
component offices during the time that an allegation is under review.
G. Categories of Individuals Covered by the System
This system includes records related to the processing and
reviewing of allegations of research misconduct levied against an
individual (the respondent) who is an agent of, or affiliated by
contract or agreement with FDA, or an FDA employee involved in
intramural research. The records contain personally identifiable
information (PII) and non-PII about respondents, complainants,
witnesses and other individuals affiliated with entities that are
contacted by or provide information to FDA.
Privacy Act notification, access, and amendment rights (described
in this document) relative to this system are available to individuals
who are subjects of records in the system, that is, respondents.
Although records in the system may contain PII related to other
individuals, only respondents are considered subjects of records in
this system.
``Respondents'' is defined as ``the person against whom an
allegation of research misconduct is directed or who is the subject of
a research misconduct proceeding.'' The term ``research misconduct'' is
defined in 42 CFR 93.103 to mean ``fabrication, falsification, or
plagiarism in proposing, performing, or reviewing research, or in
reporting research results.'' These and other definitions are set out
in 42 CFR part 93.
This system notice applies to an allegation of research misconduct
involving the following: (1) Applications or proposals for FDA support
for biomedical or behavioral extramural or intramural research or
research training, or activities related to that research or research
training; (2) FDA supported biomedical or behavioral extramural or
intramural research; (3) FDA supported extramural or intramural
research training programs; (4) FDA supported extramural or intramural
activities that are related to biomedical or behavioral research or
research training; and (5) plagiarism of research records produced in
the course of FDA supported research, research training, or activities
related to that research or research training.
H. Categories of Records in the System
The records in the system include information that must be
submitted to ORI by FDA under 42 CFR part 93 and information that FDA
obtains while conducting research misconduct proceedings. This
information may include, but is not limited to:
PII about respondents such as name, date of birth,
employment information, educational background, social security number,
personal and professional phone numbers, mailing address, and email
address;
PII regarding complainants and witnesses such as name, and
personal or work contact information;
The nature and substance of allegations;
Data regarding FDA funding related to the research and/or
respondent, including grants numbers;
The organization(s) and officials responsible for
conducting the action that are part of the research misconduct
proceeding;
The documentation used in the inquiry and investigation,
including relevant research data and materials, which may include
relevant information on study subjects;
Applications, proposals, and documentation related to
review and award actions;
Reports, abstracts, manuscripts, and publications by the
respondent(s);
Other relevant reports, abstracts, manuscripts, and
publications;
Correspondence and memoranda of telephone calls;
Summaries of interviews and transcripts or recordings of
interviews;
Statistical, scientific, and forensic analyses;
Interim and final FDA reports; and
Records of Agency findings, administrative actions, and
appeal proceedings, if any.
The system also contains general administrative and oversight
records regarding ORI actions. This includes information related to the
following: (1) ORI reviews of the research misconduct proceedings, ORI
findings of research misconduct, and ORI proposals for administrative
action or for settlement of the case; (2) a respondent's opportunity to
contest ORI findings of research misconduct and proposed HHS
administrative actions; (3) final HHS findings of research misconduct
and final decisions regarding administrative actions and their
implementation; and (4) FDA and ORI coordination with other Federal,
State, and local offices or agencies, including the DOJ.
I. Authority for Maintenance of the System
The authorities for maintaining this system are: 21 U.S.C. 371,
375, 393(d)(2), 394, 397, and 399a; 42 U.S.C. 216(b), 241, 289b; 5
U.S.C. 301; 44 U.S.C. 3101; and 42 CFR part 93.
J. Purpose
The purposes of this system are to do the following:
1. Enable FDA, ORI, HHS, and the Federal Government to protect the
health and safety of the public, to promote the integrity of FDA
supported research, and to conserve public funds.
2. Enable FDA to implement its authority relating to research
misconduct proceedings as set forth in 42 CFR part 93 and to document
FDA activities in implementing that authority.
3. Ensure that research misconduct proceedings, including FDA's
implementation of the Agency's and other HHS administrative actions,
are carried out in accordance with FDA policy, 42 CFR part 93, and
other applicable Federal statutes and regulations.
4. Enable FDA to inform Agency officials and other HHS officials
who have a need for the records in the performance of their duties of
the status and results of research misconduct proceedings.
5. Enable FDA to notify, consult with, and provide assistance to
ORI, and other Federal, State, or local agencies to permit them to take
action to protect the health and safety of the public, to promote the
integrity of FDA supported research, to conserve public funds, or to
pursue potential violations of civil and criminal statutes.
K. Routine Uses of Records Maintained in the System Including the
Purposes of Such Uses and Categories of Users
The Privacy Act lists the conditions for disclosure under 5 U.S.C.
552a(b). Among the permitted disclosures is disclosure ``to those
officers and employees of the agency which maintains the record who
have a need for the record in the performance of their duties'' (5
U.S.C. 552a(b)(1)). For this system of records, this condition would
include disclosure to the appropriate FDA, ORI, and other HHS officers
and employees.
[[Page 52039]]
Permitted disclosures also include routine uses that are listed in
the notice of the system of records (5 U.S.C. 552a(b)(3)). The Privacy
Act defines ``routine use'' as ``with respect to the disclosure of a
record, the use of such record for a purpose which is compatible with
the purpose for which it was collected.'' See also FDA's Privacy Act
regulations, defining ``routine use'' as ``use outside the Department
of Health and Human Services that is compatible with the purpose for
which the records were collected and described in the [System of
Records] notice)'' (21 CFR 21.20(b)(5)).
Records in this system that contain information about record
subjects (respondents) and nonsubjects (witnesses, complainants, and
other individuals affiliated with entities that are contacted by or
provide information to FDA) may be disclosed to recipients outside HHS
in accordance with the following routine uses:
1. Disclosure may be made to any individual or entity able to
obtain information or provide information or assistance in a research
misconduct proceeding or related proceeding. Recipients of disclosures
under this routine use may include experts asked to perform
statistical, forensic, or other analyses; the relevant FDA supported
institution(s); institutions with which the respondent(s) was
previously affiliated; Federal, State and local agencies; the
respondent(s); the complainant(s); witnesses; and organizations or
individuals acting on behalf of those agencies, institutions, and
individuals; provided, however, that in each case FDA determines
whether limited disclosures or confidentiality agreements are needed to
protect the privacy of respondent(s), complainant(s), witnesses,
research subjects, or others who may be identified in the records to be
disclosed.
2. Disclosure may be made to other Federal, State, or local
agencies and offices, if FDA has reason to believe that a research
misconduct proceeding may involve that agency or office.
3. Disclosure may be made to appropriate Federal Agencies and
Department contractors that have a need to know the information for the
purpose of assisting the Department's efforts to respond to a suspected
or confirmed breach of the security or confidentiality of information
maintained in this system of records, and the information disclosed is
relevant and necessary for that assistance.
4. Disclosure may be made to Institutional Review Boards,
collaborating institutions, and individual research subjects, regarding
information obtained or developed through a research misconduct
proceeding that, in FDA's judgment, may have implications for
individuals' health or for their participation in a research study.
5. When a record on its face, or in conjunction with other records,
indicates a violation or potential violation of law, whether civil,
criminal, or regulatory in nature, disclosure may be made to the
appropriate agency, whether Federal, foreign, State, local, or tribal,
or other public authority responsible for enforcing, investigating, or
prosecuting such violation, if the information disclosed is relevant to
the responsibilities of the agency or public authority.
6. After FDA makes a finding of research misconduct and has
informed ORI of this finding, disclosure may be made to responsible
officials of FDA supported institutions or organizations, when in
connection with a research misconduct proceeding concerning a
respondent previously or currently employed by, or affiliated with the
institution or organization, or when FDA, ORI, or HHS makes a finding
or takes an action potentially affecting the agency or organization or
its FDA support for research, research training, or related activities.
7. After FDA makes a finding of research misconduct and has
informed ORI of this finding, disclosure may be made to the
respondent's supervisor because research will be a significant part of
many employee jobs, and performance is an important element of
information to help the supervisor determine employee assignments as
well as the level of supervision needed. If an individual moves to
another job or contract, FDA may notify the other entity that we have
relevant information with regard to that individual.
8. After FDA makes a finding of research misconduct and has
informed ORI of this finding, disclosure may be made to a Federal
Agency in connection with the hiring or retention of the respondent,
the issuance of a security clearance, the reporting of an investigation
of an employee, or the issuance of a license or other benefit by the
Agency, to the extent that the record is relevant to the Agency's
decision on the matter.
9. After FDA makes a finding of research misconduct and has
informed ORI of this finding, disclosure may be made to professional
journals, other publications, news media, and the public concerning
research misconduct findings and the need to correct or retract
research results or reports that have been affected by research
misconduct, unless it is determined that release of the specific
information in the context of a particular case would constitute a
clearly unwarranted invasion of personal privacy. No information will
be released that would reveal a confidential source.
10. After FDA makes a finding of research misconduct and has
informed ORI of this finding, disclosure may be made to a State
licensing board, certifying body, or other similar entity conducting a
review of the respondent to aid the entity in meeting its
responsibility to protect the health of the population in its
jurisdiction or the integrity of the profession.
11. Disclosure may be made to contractors and other individuals or
entities who perform services for the Agency related to this system of
records and who have access to the records in order to perform such
services, including individuals appointed to serve on FDA research
misconduct inquiry committees or investigation committees if such
individuals need access to the records to perform their assigned task.
Provided, however, in each case FDA determines whether limited
disclosures or confidentiality agreements are needed to protect the
privacy of respondent(s), complainants(s), witnesses, research
subjects, or others who may be identified in the records to be
disclosed; and FDA determines that the disclosure is for a purpose
compatible with the purpose for which the Agency collected the records.
12. When FDA closes a case without a settlement or finding of
research misconduct, disclosure may be made to the respondent, relevant
institution, and complainant(s); provided, however, that in each case
FDA determines whether limited disclosures or confidentiality
agreements are needed to protect the privacy of respondent(s),
complainant(s), witnesses, research subjects, or others who may be
identified in the records to be disclosed.
13. Disclosure may be made to the DOJ when: (1) The Agency or any
component thereof; or (2) any employee of the Agency in his or her
official capacity; or (3) any employee of the Agency in his or her
individual capacity where the DOJ has agreed to represent the employee;
or (4) the U.S. 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 DOJ is therefore deemed by the Agency to be
for a purpose that is compatible with the
[[Page 52040]]
purpose for which the Agency collected the records.
14. Disclosure may be made to a court or other tribunal when: (1)
The Agency or any component thereof; or (2) any employee of the Agency
in his or her official capacity; or (3) any employee of the Agency in
his or her individual capacity where the DOJ has agreed to represent
the employee; or (4) the U.S. Government is a party to the proceeding
or has an interest in such proceeding, and by careful review, the
Agency determines that the records are both relevant and necessary to
the proceeding and the use of such records is therefore deemed by the
Agency to be for a purpose that is compatible with the purpose for
which the Agency collected the records.
15. Einstein 2 Cyber Security Monitoring: Records may become
accessible to U.S. Department of Homeland Security (DHS) cyber security
personnel, if captured in an intrusion detection system used by HHS and
DHS pursuant to the Einstein 2 program. Under Einstein 2, DHS uses
intrusion detection systems to monitor Internet traffic to and from
federal computer networks to prevent malicious computer code from
reaching the networks. According to DHS' Privacy Impact Assessment for
Einstein 2 (available on the DHS Cybersecurity privacy Web site, https://www.dhs.gov), only PII that is directly related to a malicious code
security incident is captured by and accessible to DHS, and DHS does
not access PII unless the PII is part of the malicious code.
16. Disclosure may be made to the National Archives and Records
Administration and/or the General Services Administration for the
purpose of records management inspections conducted under authority of
44 U.S.C. 2904 and 2906.
L. Policies and Practices for Storing, Retrieving, Accessing,
Retaining, and Disposing of Records in the System
1. Storage
Records may be maintained in hard copy files and on computer disks,
hard drive, and file servers, and other types of data storage devices.
2. Retrievability
Records may be retrieved by manual or computer search of the case-
tracking system using the name of the respondent(s).
3. Safeguards
a. Authorized users. Records in FDA's system are available to the
Commissioner of Food and Drugs, the Agency's Chief Scientist and Deputy
Commissioner for Science and Public Health, the Agency's Research
Integrity Officer (System Manager), and to other appropriate FDA staff
when they have a need for the records in the performance of their
duties. Records are also available to the Director of ORI and other
appropriate ORI staff, and to other appropriate HHS officials that are
involved in the research misconduct proceeding, when there is a need to
know in the performance of their duties. All authorized users are
informed that the records are confidential and are not to be further
disclosed.
b. Procedural safeguards. Access is strictly controlled by the
Research Integrity Officer (System Manager) in compliance with the
Privacy Act and this system notice. Access to the records is limited to
ensure confidentiality. All questions and inquiries from any party
should be addressed to the Research Integrity Officer (System Manager).
c. Physical safeguards. All records (such as diskettes, computer
listings, or documents) are kept in a secured area, locked rooms, and
locked building. The facility has a 24-hour guard service, and access
to the building is further controlled by an operational card key
system. Access to the files, which are generally hard copy, is limited
to a subset of individuals with general access to the building.
Access to individual offices is controlled by simplex locks.
Records are kept in locked file cabinets in a room that is locked
during non-working hours. Access to this room is restricted to specific
personnel. Access to computer files is strictly limited through
passwords and user-invisible encryption. Special measures commensurate
with the sensitivity of the record are taken to prevent unauthorized
copying or disclosure of the records.
M. Retention and Disposal
The records are maintained for 7 years in accordance with 42 CFR
part 93, FDA's Records Control Schedule, and with the applicable
General Records Schedule and disposition schedule approved by the
National Archives and Records Administration.
N. System Manager and Address
FDA Research Integrity Officer, Office of the Chief Scientist, Food
and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 4214,
Silver Spring, MD 20993.
O. Notification Procedure
In accordance with 21 CFR part 21, subpart D, an individual may
find out whether a record exists about him or her by submitting a
written request, with notarized signature if request is made by mail,
or with identification if request is made in person, directed to: FDA
Privacy Act Coordinator, Division of Freedom of Information (ELEM-
1029), Food and Drug Administration, 12420 Parklawn Dr., Element
Building, Rockville, MD 20857. HHS/FDA is exempting all records related
to research misconduct proceedings from this provision (see section I.S
of this document Records Exempted from Certain Provisions of the
Privacy Act). However, consideration will be given to requests
addressed to the Privacy Act Coordinator as described previously in
this document. In addition, some records may be exempt under 5 U.S.C
552a(d)(5), if they are ``compiled in reasonable anticipation of a
civil action or proceeding.'' See also 21 CFR 21.41(e).
P. Record Access Procedures
Procedures are the same as those in section I.O of this document
(Notification Procedure). Requests should also reasonably specify the
record contents being sought and may also request an accounting of
disclosures that have been made of the record, if any. As stated
previously in this document, HHS/FDA is exempting all records related
to research misconduct proceedings from this provision (see section I.S
of this document, Records Exempted from Certain Provisions of the
Privacy Act), and some records may be exempt under 5 U.S.C. 552a(d)(5).
However, consideration will be given to access requests addressed to
the Privacy Act Coordinator as described in section I.O of this
document (Notification Procedure).
Q. Contesting Record Procedures
In accordance with 21 CFR 21.50, contact the Privacy Act
Coordinator, Food and Drug Administration (see FOR FURTHER INFORMATION
CONTACT or section I.O of this document). Reasonably identify the
record and specify the information being contested, the corrective
action sought, and your reasons for requesting the correction, along
with supporting information to show how the record is inaccurate,
incomplete, untimely, or irrelevant. As stated previously in this
document, HHS/FDA is exempting all records related to research
misconduct proceedings from this provision (see section I.S of this
document, Records Exempted from Certain Provisions of the Privacy Act),
and some records may be exempt under 5 U.S.C. 552a(d)(5).
[[Page 52041]]
R. Record Source Categories
Information in this system is obtained from many sources, including
the following: (1) Directly from the respondent or complainant or his/
her representative; (2) derived from materials supplied by the
respondent or complainant or his/her representative; (3) from
information supplied by the institutions, witnesses, scientific
publications, and other nongovernmental sources; (4) from observation
and analysis made by FDA and ORI staff and scientific experts; (5) from
departmental and other Federal, State, and local government records;
(6) from hearings and other administrative proceedings; and (7) from
any other relevant source.
S. Records Exempted From Certain Provisions of the Privacy Act
FDA records related to research misconduct proceedings will be
exempt from the Privacy Act requirements pertaining to providing an
accounting of disclosures, access and amendment, notification, and
Agency procedures and rules under sections 552a(k)(2) and (k)(5) of the
Privacy Act.
Elsewhere in this issue of the Federal Register, FDA is publishing
a notice of proposed rulemaking and direct final rule to apply these
exemptions to records in this system related to ongoing investigations
or that would reveal a confidential source. These exemptions are
necessary to safeguard the integrity of the research misconduct
proceedings and to ensure that FDA's efforts to obtain accurate and
objective information will not be hindered. In the course of
investigations of allegations of research misconduct, it is often
necessary to give an express promise to withhold the identity of an
individual who has provided relevant information. Sources of
information necessary to complete an effective investigation may be
reluctant to provide sensitive information unless they can be assured
that their identities will not be revealed. The proposed exemptions
will ensure that the records related to ongoing investigations will not
be disclosed inappropriately and that the identities of confidential
sources will be protected.
The notice of proposed rulemaking and direct final rule provide
additional detail regarding the bases for these exemptions.
II. Comments
FDA invites comments on all parts of the systems notice. Interested
persons may submit to the Division of Dockets Management (see
ADDRESSES) either electronic or written comments regarding this
document. It is only necessary to send one set of comments. Identify
comments with the docket number found in brackets in the heading of
this document. Received comments may be seen in the Division of Dockets
Management between 9 a.m. and 4 p.m., Monday through Friday.
Dated: June 12, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-20888 Filed 8-27-12; 8:45 am]
BILLING CODE 4160-01-P
