Document ID: FDA-2011-N-0253-0001
Agency: fda
Document Type: Notice
Title: Privacy Act; Systems of Records
Posted Date: 2012-08-28T04:00Z

[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]

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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.

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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Register, unless revised or withdrawn in response to comments, the 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: http://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 http://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 http://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, http://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