
[Federal Register Volume 77, Number 5 (Monday, January 9, 2012)]
[Notices]
[Pages 1073-1076]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-114]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0454]


Privacy Act of 1974; Report of an Altered System of Records, 
Including Addition of Routine Uses to an Existing System of Records; 
Bioresearch Monitoring Information System

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of an altered system of records.

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SUMMARY: The Food and Drug Administration (FDA) is announcing an 
alteration to an existing System of Records (System) titled 
``Bioresearch Monitoring Information System, HHS/FDA'' (System No. 09-
10-0010). Among other updates, this alteration adds new routine uses 
for disclosures of certain relevant information to Agencies, 
authorities, and organizations with responsibilities related to 
clinical investigations and/or clinical investigators; persons who 
require access to records to perform services for FDA; and individual 
research subjects.

DATES: This notice will be effective without further notice on February 
8, 2012 unless modified by a subsequent notice making changes in 
response to public comments. FDA invites comments on all parts of the 
systems notice. Comments must be received on or before February 8, 
2012. See ADDRESSES for information about submission of comments.

ADDRESSES: You may submit comments identified by Docket No. FDA-2011-N-
0454 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 No. FDA-2011-N-0454 for this notice. 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: Kathleen E. Pfaender, Office of Good 
Clinical Practice, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 32, Rm. 5129, Silver Spring, MD 20993-0002, (301) 796-8340.

SUPPLEMENTARY INFORMATION:

I. Background

    The Bioresearch Monitoring Information System provides controls to

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ensure that clinical investigators meet the requirements of the 
relevant statutes and regulations governing FDA-regulated products. 
This System also supports the effective performance of activities 
necessary for the conduct of FDA's bioresearch monitoring program.

II. Description of Changes to System of Records

    We have changed, or altered, the Bioresearch Monitoring Information 
System as follows:
    (a) General necessary updates to make the System current (e.g., 
adding the Center for Tobacco Products and the Office of Good Clinical 
Practice, updating addresses and revising citations).
    (b) Adding to the categories of records in the System: clinical 
investigator financial arrangements with or interests in a study 
sponsor, because this information may be included in this System.
    (c) Deleting an unnecessary routine use authorizing disclosure to 
congressional offices in response to inquires from constituents who 
authorize disclosure by written consent. This routine use is 
unnecessary because the Privacy Act and FDA regulations permit 
disclosure upon prior written consent by the individual who is the 
subject of the records. (5 U.S.C. 552a(b), 21 CFR 21.70(a)(2) and 
21.72).
    (d) Amending part 1 of former routine use 1 to provide for 
disclosure to Federal, State, and local Agencies; government 
institutions; State licensing authorities; foreign governments/
Agencies; international organizations; and non-governmental regulatory 
bodies of a foreign country. Such disclosure must be relevant to that 
entity's oversight, investigative, regulatory, licensing, or 
enforcement responsibilities for clinical investigations and/or 
clinical investigators. This includes any referrals related to 
potential violations of law, as had been provided for under part 1 of 
former routine use 1 (routine use 1).
    (e) Amending part 2 of former routine use 1 to provide for 
disclosure to sponsors, institutional review boards, and other non-
government entities if the information disclosed is relevant to the 
receiving entity's responsibility for the initiation, oversight, 
monitoring, compliance, or other regulatory requirement associated with 
the conduct of clinical investigations or oversight of a clinical 
investigator (routine use 2).
    (f) Providing for disclosure to a research subject of information 
from a research misconduct proceeding that may have implications for 
that subject's rights, safety, or welfare, or participation in a 
research study (routine use 3).
    (g) Providing for disclosure to the public of information related 
to a clinical investigator's financial arrangements with or interests 
in a study sponsor, to the extent disclosure is not an unwarranted 
invasion of personal privacy or is not otherwise protected from 
disclosure under FDA's regulations or applicable statutes (routine use 
4).
    (h) Providing for disclosure to the public of regulatory 
information and/or correspondence, including untitled letters, Notice 
of Initiation of Disqualification Proceedings and Opportunity to 
Explain letters, Notice of Opportunity for Hearing letters, and warning 
letters issued to clinical investigators, and summary information from 
inspections of clinical investigators involved in FDA-regulated 
research, to the extent disclosure is not an unwarranted invasion of 
personal privacy or is not otherwise protected from disclosure under 
FDA's regulations or applicable statutes (routine use 5).
    (i) Providing for disclosure to persons who require access to 
records in order to perform services for FDA, such as serving on FDA 
research misconduct inquiry committees (routine use 6).
    (j) Providing for disclosure to the appropriate Federal Agencies 
and HHS contractors in responding to a breach of the security or 
confidentiality of information in this System (routine use 7).

III. Comments

    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. It is no 
longer necessary to send two copies of mailed 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.
    The following is a copy of the altered System of Records. FDA 
invites comments on all parts of the System of Records (see section III 
of this document for information about submission of comments):
System No. 09-10-0010

SYSTEM NAME
    Bioresearch Monitoring Information System, HHS/FDA.

SECURITY CLASSIFICATION
    None.

SYSTEM LOCATIONS
    Center for Biologics Evaluation and Research, Office of Compliance 
and Biologics Quality, Bioresearch Monitoring Team (refer to http://www.fda.gov for address specifics).
    Center for Devices and Radiological Health, Office of Compliance, 
Division of Bioresearch Monitoring (refer to http://www.fda.gov for 
address specifics).
    Center for Drug Evaluation and Research, Office of Compliance, 
Division of Scientific Investigations (refer to http://www.fda.gov for 
address specifics).
    Center for Food Safety and Applied Nutrition, Office of Food 
Additive Safety, (refer to http://www.fda.gov for address specifics).
    Office of Regulatory Affairs, Office of Enforcement (refer to 
http://www.fda.gov for address specifics), and Regional Field Offices 
(refer to www.fda.gov for address specifics).
    Center for Tobacco Products (refer to http://www.fda.gov for 
address specifics).
    Center for Veterinary Medicine, Division of Compliance, Bioresearch 
Monitoring Program (refer to http://www.fda.gov for address specifics).
    Office of Good Clinical Practice, Office of the Commissioner (refer 
to http://www.fda.gov for address specifics).

CATEGORIES OF INDIVIDUALS COVERED BY THE SYSTEM
    This notice applies to clinical investigators who are conducting, 
or have conducted, clinical investigations of products regulated by 
FDA.

CATEGORIES OF RECORDS IN THE SYSTEM
    This system includes records, regardless of format (e.g., 
electronic, hard copy, scanned), pertaining to clinical investigators 
who conduct research of products regulated by FDA, for example a 
clinical investigation that supports an application for a research or 
marketing permit for an FDA-regulated product. Records contain name, 
education, professional qualifications and background, and information 
on studies conducted. Records that contain information about certain 
financial arrangements with or interests in study sponsors may also be 
included in this system.
    This system also contains records created or collected during 
inspections or investigations of clinical investigators for possible 
violations of statutes or regulations governing clinical investigations 
of FDA-regulated products.

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AUTHORITY FOR MAINTENANCE OF THE SYSTEM
    The authorities for maintaining this system are: Section 505(i) of 
the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 
355(i)(3)), 21 CFR part 312; Section 520(g) of the FD&C Act (21 U.S.C. 
360j), 21 CFR part 812; Sections 512(j) and (l)(1) of the FD&C Act (21 
U.S.C. 360b(j) and (l)(1)), 21 CFR part 511; Sections 409 and 721 of 
the FD&C Act (21 U.S.C. 348 and 379e), 21 CFR part 71, 21 CFR part 171; 
Section 412 of the FD&C Act (21 U.S.C. 350a); Section 910 of the FD&C 
Act (21 U.S.C. 387j); Section 351 of the Public Health Service Act (42 
U.S.C. 262).

PURPOSES
    The purposes of this system are to:
    1. Support regulatory or procedural controls to ensure that 
clinical investigators meet requirements of the relevant statutes and 
regulations governing clinical investigations of FDA-regulated 
products.
    2. Support the effective performance of activities necessary for 
the conduct of the FDA's bioresearch monitoring program.

ROUTINE USES OF RECORDS MAINTAINED IN THE SYSTEM, INCLUDING CATEGORIES 
OF USERS AND THE PURPOSES OF SUCH USES
    The Privacy Act lists the conditions of disclosure under 5 U.S.C. 
552a(b). Among the permitted disclosures is, ``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 would include disclosure to 
appropriate FDA and Department of Health and Human Services (HHS) 
employees.
    Permitted disclosures also include routine uses that are listed in 
the notice of the system of records. (See 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'' (5 U.S.C. 552a(a)(7)). 
See also FDA's Privacy Act Record Systems 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)).
    The routine uses for this system of records are listed in the 
following numbered items.
    1. Disclosure may be made to Federal, State, and local Agencies; 
government institutions; state licensing authorities; foreign 
governments/Agencies; international organizations; and non-governmental 
regulatory bodies of a foreign country. Such disclosure must be 
relevant to that entity's oversight, investigative, regulatory, 
licensing, or enforcement responsibilities for clinical investigations 
and/or clinical investigators. This includes referrals for 
investigation and possible enforcement action to the U.S. Department of 
Justice and other appropriate Agencies, authorities, and organizations.
    2. Disclosure may be made to sponsors, institutional review boards, 
and other non-government entities if the information disclosed is 
relevant to the receiving entity's responsibility for the initiation, 
oversight, monitoring, compliance, or other regulatory requirement 
associated with the conduct of clinical investigations and/or oversight 
of clinical investigators.
    3. Disclosure may be made to an individual research subject of 
information obtained or developed through a research misconduct 
proceeding if, in FDA's judgment, the information may have implications 
for that subject's rights, safety, or welfare, or participation in a 
research study.
    4. Disclosure may be made to the public of information related to a 
clinical investigator's financial arrangements with or interest in a 
study sponsor, to the extent disclosure is not an unwarranted invasion 
of personal privacy or is not otherwise protected from disclosure under 
FDA's regulations or applicable statutes. Examples of the financial 
arrangements that FDA may disclose include but are not limited to 
outcome payments (i.e., where the payment to the clinical investigator 
is dependent on the outcome of the study) and proprietary interests 
(e.g., where the clinical investigator holds a patent).
    5. Disclosure may be made to the public of regulatory information 
and/or correspondence, including untitled letters, Notice of Initiation 
of Disqualification Proceedings and Opportunity to Explain (NIDPOE) 
letters, Notice of Opportunity for Hearing (NOOH) letters, and warning 
letters issued to clinical investigators, and summary information from 
inspections of clinical investigators, to the extent disclosure is not 
an unwarranted invasion of personal privacy or is not otherwise 
protected from disclosure under FDA's regulations or applicable 
statutes.
    6. Disclosure may be made to persons who require access to the 
records to perform services for FDA, for example, persons appointed to 
serve on FDA research misconduct inquiry committees or investigative 
committees, and FDA contractors, if such persons need access to the 
records to perform their assigned task. Provided, however, in each case 
FDA determines whether limitations on disclosures or confidentiality 
agreements are needed to protect the privacy of respondents, 
complainants, 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 FDA 
collected the records.
    7. Disclosure may be made to appropriate Federal Agencies and HHS 
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.
    8. Disclosure may be made to the U.S. Department of Justice (DOJ) 
when: (a) the Agency or any component thereof; or (b) any employee of 
the Agency in his or her official capacity; or (c) any employee of the 
Agency in his or her individual capacity where the DOJ has agreed to 
represent the employee; or (d) the United States Government, is a party 
to litigation or has an interest in such litigation and, by careful 
review, the Agency determines that the records are both relevant and 
necessary to the litigation and the use of such records by the DOJ is 
therefore deemed by the Agency to be for a purpose that is compatible 
with the purpose for which the Agency collected the records.
    9. Disclosure may be made to a court or other tribunal, when: (a) 
The Agency or any component thereof; or (b) any employee of the Agency 
in his or her official capacity; or (c) any employee of the Agency in 
his or her individual capacity where the DOJ has agreed to represent 
the employee; or (d) the United States 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.

POLICIES AND PRACTICES FOR STORING, RETRIEVING, ACCESSING, RETAINING, 
AND DISPOSING OF RECORDS IN THE SYSTEM
STORAGE:
    Files may be maintained in various formats including hard copy 
paper in manual files, microfilm, magnetic disk or tape, computer 
disks, hard drives,

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and file servers and other types of data storage devices.

RETRIEVABILITY:
    Records may be indexed by name or code number, but can be retrieved 
by manual or computer search of the case-tracking system using the name 
of the individual.

SAFEGUARDS:
    1. Authorized users:
    Records in FDA's system are available to the Commissioner of Food 
and Drugs, FDA's System Managers, and to other appropriate FDA and HHS 
officials 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.
    2. Procedural safeguards:
    Access is strictly controlled by FDA's System Managers 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 FDA's Office of Good 
Clinical Practice.
    3. 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, are limited to a subset of 
persons 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.

RETENTION AND DISPOSAL:
    The records are maintained in accordance with FDA's Records Control 
Schedule, applicable General Records Schedule (accessions), and 
disposition schedule approved by the National Archives and Records 
Administration (cases).

SYSTEM MANAGERS AND ADDRESSES:
    Division of Inspections and Surveillance, Center for Biologics 
Evaluation and Research, Office of Compliance and Biologics Quality 
(refer to http://www.fda.gov for address specifics).
    Division of Bioresearch Monitoring, Center for Devices and 
Radiological Health, Office of Compliance (refer to http://www.fda.gov 
for address specifics).
    Division of Scientific Investigations, Center for Drug Evaluation 
and Research, Office of Compliance (refer to http://www.fda.gov for 
address specifics).
    Office of Food Additive Safety, Center for Food Safety and Applied 
Nutrition (refer to http://www.fda.gov for address specifics).
    Office of Enforcement, Office of Regulatory Affairs (refer to 
http://www.fda.gov for address specifics), and Regional Field Offices 
(refer to http://www.fda.gov for address specifics).
    Center for Tobacco Products (refer to http://www.fda.gov for 
address specifics).
    Division of Compliance, Center for Veterinary Medicine, Bioresearch 
Monitoring Program (refer to http://www.fda.gov for address specifics).
    Office of Good Clinical Practice, Office of the Commissioner (refer 
to http://www.fda.gov for address specifics).

NOTIFICATION PROCEDURES:
    In accordance with 21 CFR part 21 subpart D, an individual may 
submit a request to the FDA Privacy Act Coordinator, with a notarized 
signature, to confirm whether records exist about that individual. 
Requests should be directed to the FDA Privacy Act Coordinator (refer 
to http://www.fda.gov for the address specifics). Investigative records 
are exempt from this provision (see the following sentences: Records 
Exempted from Certain Provisions of the Act). 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. Requests may be mailed to the FDA Privacy Act Coordinator 
(refer to http://www.fda.gov for the address specifics).

RECORD ACCESS PROCEDURES:
    Same as notification procedures. Requesters should specify the 
record contents being sought. Access to record systems which have been 
granted an exemption from the Privacy Act access requirement may be 
made at the discretion of the system manager. If access is denied to 
requested records, an appeal may be made to the FDA Commissioner. A 
request can also be made for an accounting of disclosures that have 
been made of a record, if any.

CONTESTING RECORD PROCEDURES:
    In accordance with 21 CFR 21.50, contact the FDA Privacy Act 
Coordinator (refer to http://www.fda.gov), and reasonably identify the 
record, 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, 
investigative records are exempt from this provision (see the following 
paragraphs of this document: Records Exempted from Certain Provisions 
of the Act). 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.''

RECORD SOURCE CATEGORIES:
    Individual on whom the record is maintained. Some material is 
obtained from third parties (e.g., a study sponsor, publication, or 
institutional review board), or is developed by FDA.

RECORDS EXEMPTED FROM CERTAIN PROVISIONS OF THE ACT:
    Investigatory records compiled for law enforcement purposes in this 
system are exempt from the notification, access, correction and 
amendment provisions of the Privacy Act (21 CFR 21.61).

    Dated: January 4, 2012.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2012-114 Filed 1-6-12; 8:45 am]
BILLING CODE 4164-01-P


