
[Federal Register Volume 79, Number 235 (Monday, December 8, 2014)]
[Proposed Rules]
[Pages 72687-72690]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-28634]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-N-1697]


Privacy Act of 1974; Report of a New System of Records; Food and 
Drug Administration Commissioning of State and Local Officials

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 or the 
Agency) regulations for the protection of privacy, FDA is publishing 
notice of a Privacy Act system of records entitled, ``FDA Commissioning 
of State and Local Officials, HHS/FDA/ORA'' System No. 09-10-0022. FDA 
is deleting the System of Records Notice (SORN) for ``FDA Credential 
Holder File, HHS/FDA/OC'' System No. 09-10-0003, because the records 
covered by that SORN are now covered by this new SORN and by existing 
personnel records SORNs. The new system of records will contain 
information about State and local officials who have applied for an FDA 
commission that would allow them to assist FDA with its regulatory 
compliance and enforcement efforts. FDA will use the records in this 
system to assess qualifications of commissioning candidates, initiate 
background investigations, record the status of applications, and track 
the status of commissioned officials.

DATES: Effective Date: The new system of records will be effective on 
December 8, 2014 with the exception of the routine uses. The routine 
uses will be effective on January 22, 2015. Submit either electronic or 
written comments by January 22, 2015.

ADDRESSES: You may submit comments 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:
     Mail/Hand delivery/Courier (for paper 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 Docket No. 
FDA-2014-N-1697 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: Ryan Cates, Office of Partnerships, 
Food and Drug Administration, Element Building, 12420 Parklawn Dr., 
Rockville, MD 20857, 301-796-5390, FAX: 301-827-3588, OP-ORA@fda.hhs.gov.

SUPPLEMENTARY INFORMATION:

I. Background on the New System and the Deleted System

    The FDA is establishing a new system of records referred to as the 
Commissioning of State and Local Officials (COSLO) system, to maintain 
records regarding State and local officials who apply to be 
commissioned by FDA. Under section 702(a)(1)(A) of the Federal Food, 
Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 372(a)(1)(A)), FDA can 
commission a health, food, or drug officer or employee of any State, 
territory, or political subdivision thereof (hereafter State and local 
officials) to conduct examinations and investigations for the purposes 
of the FD&C Act.
    In addition, FDA is deleting the SORN entitled ``FDA Credential 
Holder File, HHS/FDA/OC'' (System No. 09-10-0003). The records covered 
by that SORN (credential records for FDA employees and commissioned 
officials) will now be covered by this SORN for the COSLO system which 
contains records pertaining to commissioned officials, and by other 
existing personnel SORNs for records pertaining to FDA employees.
    Issued in Homeland Security Presidential Directive 12, ``Policy for 
a Common Identification Standard for Federal Employees and 
Contractors,'' FDA has completed the process of issuing Personal 
Identity Verification (PIV) badges to current employees and 
contractors, and will do the same for all new employees and contractors 
hired in the future. Records pertaining to those badges and background 
investigations are covered under HHS department-wide SORN No. 09-90-
0777 entitled ``Facility and Resource Access Control Records System.'' 
Any additional records maintained to identify or manage FDA personnel 
designated to conduct examinations and inspections under the FD&C Act 
would be covered by HHS department-wide SORN No. 09-90-0018 entitled 
``Personnel Records in Operating Offices'' or another personnel SORN.
    State and local officials who assist with FD&C Act examinations and 
inspections are issued one or two types of credentials that differ in 
scope. All commissioned individuals receive Certificates of Commission 
and are permitted to receive and review FDA documents. A subset of 
commissioned individuals also receive personal ``pocket credentials'' 
identifying them as FDA commissioned officers and authorizing them to 
perform additional activities such as conducting inspections, 
collecting samples, and verifying records. To obtain pocket 
credentials, State and local officials undergo an Office of Personnel 
Management level 5 background investigation. FDA commission credentials 
are different from the PIV badges issued to FDA employees and 
contractors, and are manufactured and issued by FDA's Office of 
Security Operations, and are not within the scope of HHS department-
wide SORN No. 09-90-0777.

II. The Privacy Act

    The Privacy Act of 1974 (Pub. L. 93-579) (5 U.S.C. 552a), as 
amended, governs the means by which the U.S. Government collects, 
maintains, and uses information about individuals in a system of 
records. A ``system of records'' is a group of any records under the 
control of a Federal Agency from which information about an individual 
is retrieved by the individual's name or other personal identifier. The 
Privacy Act requires each Agency to publish in the Federal Register a 
SORN identifying and describing each system of records the Agency 
maintains, including the purposes for which the Agency uses information 
about individuals in the system, the routine uses for which the Agency 
discloses such information outside the Agency, and how individual 
record subjects can exercise their rights under the Privacy Act (for 
example, to determine if the system contains information about them).

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A. System Number

09-10-0022

B. System Name
    FDA Commissioning of State and Local Officials, HHS/FDA/ORA.

C. Security Classification
    Unclassified.

D. System Location
    Records are maintained at several FDA Headquarters locations and in 
component offices of the FDA, in both Montgomery County, MD and field 
locations across the United States.

E. Categories of Individuals Covered by the System
    The records in this system will contain data collected from the FDA 
commissioning applications of individuals who are State and local 
officials who wish to be commissioned under section 702(a)(1)(A) of the 
FD&C Act. This information is gathered for the purpose of processing 
and validating each individual's qualifications for commissioning, to 
initiate the mandatory background investigation, and to track the 
status of commissioned officials.
    Privacy Act notification, access, and amendment rights relative to 
the records maintained in this system are available only to individuals 
who are the subject of records in this system. The individuals who are 
the subjects of the records stored in this system are the State or 
local officials who are currently commissioned, have applied for a 
commission, and/or were commissioned or rejected in the past. Although 
records in the system may contain personally identifiable information 
related to other individuals, only the specified commissioned or 
commission-seeking individuals are considered subjects of records in 
this system.

F. Categories of Records in the System
    The records in this system will include: Full name, aliases, date 
of birth, home address, work address, telephone number, work or 
personal email address, photograph, educational history, job title, 
agency, division, area of expertise, employment history, supervisor's 
name, signature, and the outcome of the background investigation of 
individuals who apply for a commission. Should a commissioned 
individual with pocket credentials lose their credentials, he or she 
will typically file a police report and provide a copy of the report to 
FDA where it is kept in the individual's commissioning file. In 
addition, the records in the system will describe the nature of the 
authority granted to a commissioned individual, the relevant regulatory 
program area, the date the commission was issued, and date of 
expiration.

G. Authority for Maintenance of the System
    The authorities for maintaining this system are: Section 702(a) of 
the FD&C Act, 44 U.S.C. 3101, and 5 U.S.C. 301.

H. Purpose(s) of the System
    Relevant Agency personnel will use records from this system on a 
need-to-know basis to:
     Centrally gather data enabling FDA to determine the 
suitability, eligibility, and qualifications of State and local 
officials to whom FDA might offer commissions;
     enable FDA to securely commission and credential State and 
local officials who are particularly qualified to assist FDA in a 
special manner for which FDA credentials are required;
     ensure the safety and security of FDA facilities, systems, 
information, and of facility occupants and users;
     provide appropriate access to FDA information systems, 
networks, and resources;
     enhance FDA's ability to ensure the safety of FDA-
regulated products through a secure commissioning process; and
     centrally gather data on commissioned officials, thereby 
enabling FDA to efficiently maintain the commissioning program and to 
support activities, such as quickly ascertaining which officials are 
particularly qualified to carry out official responsibilities and 
providing this information as necessary to our State and local 
counterparts.

I. Routine Uses of Records Maintained in the System, Including 
Categories of Users and the Purposes of Such Uses
    These routine uses specify circumstances, in addition to those 
provided by the Privacy Act at 5 U.S.C. 552a(b), under which records 
may be disclosed to recipients outside HHS, without the individual 
record subject's prior written consent:
     Public disclosures may be made (for example, on FDA's Web 
site) of the names of commissioned officials, and other basic 
information, including the identification of their State or local 
agency, their job titles, the type of commission, any specific 
commissioned areas, and the date of their commission, to the extent 
disclosure is not an unwarranted invasion of personal privacy.
     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, provided the information 
disclosed is relevant and necessary for that assistance.
     Disclosure may be made to a Federal, State, local, 
territorial, tribal, foreign, or other public authority, on request, in 
connection with the hiring or retention of an employee, the issuance or 
retention of a security clearance, the letting of a contract, or the 
issuance or retention of a license, grant, or other benefit, to the 
extent that the information is relevant and necessary to the requesting 
Agency's decision. No disclosure will be made unless the information 
has been determined to be sufficiently reliable to support a referral 
to another office within the Agency or to another Federal Agency for 
criminal, civil, administrative, personnel, or regulatory action.
     Disclosure of system information may be made to a State, 
local, territorial, and tribal agencies or governments to provide 
copies of records that were originally provided to the Agency by that 
entity.
     Disclosure may be made to Federal Agencies, contractors, 
and other individuals or entities who perform services for the Agency 
related to this system of records and who need access to the records to 
perform those services. Recipients shall be required to comply with the 
requirements of the Privacy Act of 1974, as amended, 5 U.S.C. 552a.
     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 public authority, whether Federal, foreign, State, local, 
or tribal, or otherwise, responsible for enforcing, investigating, or 
prosecuting such violation, if the information disclosed is relevant to 
the responsibilities of the Agency or public authority.
     Disclosure may be made to a court or other tribunal or 
adjudicative body in a proceeding, when:
    [cir] The Agency or any component thereof; or
    [cir] any employee of the Agency in his or her official capacity; 
or
    [cir] any employee of the Agency in his or her individual capacity 
where the Department of Justice (DOJ) has agreed to represent the 
employee; or
    [cir] 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

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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.
     Disclosure may be made to the National Archives and 
Records Administration (NARA) and/or the General Services 
Administration for the purpose of records management inspections 
conducted under authority of 44 U.S.C. 2904 and 2906.
     Disclosure may be made to the DOJ when:
    [cir] The Agency or any component thereof; or
    [cir] any employee of the Agency in his or her official capacity; 
or
    [cir] any employee of the Agency in his or her individual capacity 
where the Agency or the DOJ has agreed to represent the employee; or
    [cir] 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 purpose 
for which the Agency collected the records.
     In the event HHS/FDA deems it desirable or necessary, in 
determining whether particular records are required to be disclosed 
under the Freedom of Information Act, disclosure may be made to the DOJ 
for the purpose of obtaining its advice.

J. Policies and Practices for Storing, Retrieving, Accessing, 
Retaining, and Disposing of Records in the System
1. Storage
    Records are maintained in hard copy files, image files, electronic 
hard drive, file servers, and other electronic data storage devices.

2. Retrievability
    To retrieve information, the system database is typically queried 
using any of the internal data fields. The data fields encompass any 
data criterion that is entered into the system including, but not 
limited to, name, FDA region, credential number (if issued pocket 
credentials), certificate expiration date, State, program area, or 
authority.

3. Safeguards
    a. Authorized users. Access is restricted to FDA employees and 
contractors with a Level 5 or higher clearance who have a need for the 
records in the performance of their duties.
    b. Procedural and technical safeguards. Technical controls include 
identification and authentication of the authorized user, access 
control, audit and accountability, system and communication protection, 
timely account disablement/deletion, configuration management, 
maintenance, system and information integrity, media protection, and 
incident response. These controls extend to remote users as well.
    c. Physical safeguards. Physical safeguards include controlled-
access buildings where all records (such as diskettes, computer 
listings, and paper documents) are maintained in secured areas, locked 
buildings, locked rooms, and locked cabinets.

K. Retention and Disposal
    Commissioning records are maintained in accordance with FDA's 
Records Control Schedule and the applicable General Records Schedule 
and disposition schedules approved by NARA. Commissioning records fall 
under NARA approved citation N1-088-09-02 for Commissioning Documents, 
the Nationwide List of FDA Commissions, and Summary Reports of FDA 
Commissions. Commissioning documents are deleted/destroyed 5 years 
after the end of the fiscal year in which a commission is revoked or 
expires. Records within the nationwide list of FDA commissions are 
deleted/destroyed 5 years after the fiscal year when they become 
obsolete or are superseded. Summary reports of FDA commissions are 
deleted/destroyed after the nationwide list of FDA Commissions has been 
updated.

L. System Manager(s) and Address
    Ryan Cates, Food and Drug Administration, Office of Partnerships, 
Element Building, 12420 Parklawn Dr., Rockville, MD 20857, 301-796-
5390, FAX: 301-827-3588, OP-ORA@fda.hhs.gov.

M. Notification Procedure
    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 him or her. Requests 
should be directed to the FDA Privacy Act Coordinator, Division of 
Freedom of Information, 12420 Parklawn Dr., ELEM-1029, Rockville, MD 
20857. An individual requesting notification via mail should certify in 
his or her request that he or she is the individual who he or she 
claims to be and that he or she understands that the knowing and 
willful request for or acquisition of a record pertaining to an 
individual under false pretenses is a criminal offense under the 
Privacy Act subject to a $5,000 fine, and indicate on the envelope and 
in a prominent manner in the request letter that he or she is making a 
``Privacy Act Request.'' Additional details regarding notification 
request procedures appear in 21 CFR part 21, subpart D. A commission 
holder may also request an opportunity to review his or her own file by 
contacting the appropriate Regional Food and Drug Director.

N. Record Access Procedures
    Procedures are the same as above, in the Notification Procedure 
section. Requesters should also reasonably specify the record contents 
being sought. Some records may be exempt from access under 5 U.S.C. 
552a(d)(5), if they are ``compiled in reasonable anticipation of a 
civil action or proceeding.'' If access to requested records is denied, 
the requester may appeal the denial to the FDA Commissioner. Additional 
details regarding record access procedures and identity verification 
requirements appear in 21 CFR part 21, subpart D.

O. Contesting Record Procedures
    In addition to the procedures described above, requesters should 
reasonably identify the record, specify the information they are 
contesting, state the corrective action sought and the reasons for the 
correction, and provide information justifying why the record is not 
accurate, complete, timely, or relevant to an FDA purpose. Rules and 
procedures regarding amendment of Privacy Act records appear in 21 CFR 
part 21, subpart E.

P. Record Source Categories
    Information in this system is obtained from the following sources: 
Directly from a commissioned individual or individual under 
consideration for commissioning; FDA employee; FDA contractor; 
sponsoring State, local or Federal agency; former sponsoring, employing 
or commissioning agency; other State, local or Federal agencies; 
contract employer; and the subject individual's former employer.

Q. Records Exempted from Certain Provisions of the Privacy Act
    None.
III. Comments
    Interested persons may submit either electronic comments regarding 
this document to http://www.regulations.gov or written comments to the 
Division of Dockets Management (see ADDRESSES). It is only necessary to 
send one set of comments. Identify comments with the docket number 
found in brackets in the

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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, 
and will be posted to the docket at http://www.regulations.gov.

    Dated: December 1, 2014.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2014-28634 Filed 12-5-14; 8:45 am]
BILLING CODE 4164-01-P


