Federal Register / Vol. 73, No. 73 / Tuesday, April 15, 2008 / Notices 20309 

RETRIEVABILITY: 

System records can be retrieved by an 

identification number assigned to a 

child support case by the State child 

support agency or an SSN of the 

individuals whose records are 

maintained in the FCR. 

SAFEGUARDS: 

OCSE has established appropriate 

administrative, technical and physical 

safeguards to ensure the security and 

confidentiality of records maintained in 

the FCR. These safeguards include, but 

are not limited to, the following: 

(1) Administrative Safeguards. On an 

annual basis, a risk assessment and a 

security assessment are conducted. 

Personnel are required to undergo 

background checks and must participate 

annually in security awareness training. 

(2) Technical Safeguards. Identification 

and authentication controls for access to 

the system and for access to the datasets 

are used, with audit logging for 

accountability. Records are encrypted 

prior to transmission. Firewalls and 

intrusion detection equipment are in 

place. (3) Physical Safeguards: Policies 

and procedures limit physical access to 

the system and the facility in which it 

is housed, while ensuring that 

authorized access is allowed. Guards, 

electronic monitoring, access keys, 

personal badges and physical barriers 

all contribute to the physical 

safeguarding of the system and the 

records maintained therein. 

Records maintained in the FCR are 

secured in full compliance with Federal 

requirements, including the Federal 

Information Security Management Act 

and the HHS Security Program Policy, 

and in accordance with requirements 

governing a FIPS 199 categorized 

system. The FCR is fully certified and 

accredited in accordance with HHS 

requirements and guidance issued by 

the National Institute of Standards and 

Technology. 

RETENTION AND DISPOSAL: 

(1) Records provided from State child 

support agencies. (a) Electronic records 

furnished by the State child support 

agency containing child support case 

and order information (input files) are 

retained for 60 days and then deleted. 

(b) State agency records (as posted to the 

FCR) remain within the FCR until 

removed, upon notification by the State 

agency that the case is closed and 

notifies OCSE to remove it from the 

FCR, provided that, upon request, a 

sample may be retained for research 

purposes found by OCSE to be likely to 

contribute to achieving the purposes of 

child support programs or the TANF 

program, but without personal 

identifiers. (c) Records pertaining to 

closed cases are archived on the fiscal 

year basis and retained for two years. 

Family violence indicators are removed 

from the individual’s record, upon 

request by the State that initiated the 

indicator. (2) Locate requests and match 

results. (a) Locate requests submitted by 

State child support agencies and other 

authorized persons are retained for 60 

days and are then deleted. (b) Audit trail 

records of locate requests and 

disclosures of match results pursuant to 

those requests, which include 

indications of which Federal agencies 

were contacted for locate information, 

whether information was located, and 

the type(s) of information returned to 

the requesting entity. These records are 

archived once a year based on the fiscal 

year. The records are retained for two 

completed fiscal years and then 

destroyed. These records indicate the 

type of information located for the 

authorized user, not the information 

itself. (c) Copies of records containing 

information from the NDNH or other 

agencies obtained pursuant to locate 

requests are provided to authorized 

persons through the FCR. They are 

maintained within the FCR for one year 

for the purpose of electronically filtering 

and suppressing redundant information 

from being transmitted. After one year, 

the records are deleted. (3) Match 

results generated as a result of FCR to 

FCR comparisons which locate 

individuals who are participants in 

child support cases or orders in more 

than one state are transmitted to the 

relevant States. Copies of FCR to FCR 

match results are retained for 60 days 

and then deleted. (4) Any record 

relating or potentially relating to a fraud 

or abuse investigation or a pending or 

ongoing legal action including a class 

action, is retained until conclusion of 

the investigation or legal action. (5) 

Copies of the FCR records transmitted 

annually to the IRS for the purpose of 

administering the earned income tax 

credit (routine use 12) are retained for 

one year and then deleted. 

SYSTEM MANAGER(S) AND ADDRESS: 

Director, Division of Federal Systems, 

Office of Automation and Program 

Operations, Office of Child Support 

Enforcement, Administration for 

Children and Families, 370 L’Enfant 

Promenade, SW., 4th Floor East, 

Washington, DC 20447. 

NOTIFICATION PROCEDURES: 

To determine if a record exists, write 

to the Systems Manager at the address 

listed above. The Privacy Act requires 

that, except under certain conditions 

specified in the law, only the subject of 

the records may have access to them. 

All requests must be submitted in the 

following manner: Identify the system of 

records to be searched, have the request 

notarized to verify requestor’s identity, 

and requestor should indicate 

awareness that the knowing and willful 

request for or acquisition of a Privacy 

Act record under false pretenses is a 

criminal offense subject to a $10,000 

fine. The requestor’s letter must also 

provide sufficient particulars to enable 

OCSE to distinguish between records on 

subject individuals with the same name. 

RECORD ACCESS PROCEDURES: 

Write to the Systems Manager 

specified above to attain access to 

records. Requestors should provide a 

detailed description of the record 

content they are seeking. 

CONTESTING RECORD PROCEDURES: 

Contact the official at the address 

specified under the Systems Manager 

above, and identify the record and 

specify the information to be contested 

and corrective action sought with 

supporting justification to show how the 

record is inaccurate, incomplete, 

untimely, or irrelevant. 

RECORD SOURCE CATEGORIES: 

Records maintained within the FCR 

are furnished by State child support 

agencies. Records disseminated from the 

FCR for the purpose of providing locate 

information from the NDNH and other 

Federal agencies are furnished by 

departments, agencies, or 

instrumentalities of the United States or 

any State, employers, financial 

institutions, and insurers or their agents. 

Records maintained for the purpose of 

filtering redundant data are also 

furnished by these sources. 

EXEMPTIONS CLAIMED FROM THE SYSTEM: 

None. 

[FR Doc. E8–7944 Filed 4–14–08; 8:45 am] 

BILLING CODE 4184–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2008–N–0225] 

Antimicrobial Resistance; Public 

Hearing; Request for Comments 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of public hearing; request 

for comments. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing a 


jlentini on PROD1PC65 with NOTICES
20310 Federal Register / Vol. 73, No. 73 / Tuesday, April 15, 2008 / Notices 

1 (FDA has verified the Web site address, but FDA 

is not responsible for any subsequent changes to the 

Web site after this document publishes in the 

Federal Register.) 

public hearing on antimicrobial 

resistance. FDA is seeking general 

information about the problem of 

antimicrobial resistance, 

recommendations as to possible 

approaches to contain the problem of 

antimicrobial resistance, responses to 

specific questions (see section III of this 

document), and other pertinent 

information from interested parties. In 

addition, interested parties may provide 

views on which serious and lifethreatening infectious diseases, such as 

diseases due to gram-negative bacteria 

and other diseases due to antimicrobialresistant bacteria, potentially qualify for 

available grants and contracts or other 

development incentives. 

DATES: The public hearing will be held 

April 28, 2008, from 8 a.m. to 5 p.m. 

Submit written or electronic notices of 

participation by close of business on 

April 21, 2008. Written or electronic 

comments will be accepted until May 

26, 2008. 

ADDRESSES: The public hearing will be 

held at the University System of 

Maryland Shady Grove Center, 9630 

Gudelsky Dr., Rockville, MD 20850. 

See REGISTRATION TO ATTEND AND/OR

PARTICIPATE IN THE PUBLIC HEARING for 

instructions on how to submit electronic 

notices of participation. 

Submit written comments to the 

Division of Dockets Management (HFA–

305), Food and Drug Administration, 

5630 Fishers Lane, rm. 1061, Rockville, 

MD 20852. Submit electronic comments 

to http://www.regulations.gov. All 

comments should be identified with the 

docket number found in brackets in the 

heading of this document. 

FOR FURTHER INFORMATION CONTACT: 

Nancy Stanisic, Office of Critical Path 

Programs (HF–18), Food and Drug 

Administration, 5600 Fishers Lane, 

Rockville, MD 20857, 301–827–1660, 

FAX 301–443–9718, 

nancy.stanisic@fda.hhs.gov. 

REGISTRATION TO ATTEND AND/OR

PARTICIPATE IN THE PUBLIC HEARING: To 

ensure there is sufficient room we ask 

that you pre-register. If you wish to 

make an oral presentation during the 

open public comment period of the 

hearing, state your intention to present 

on your registration submission. To 

register, please send an electronic mail 

message to nancy.stansic@fda.hhs.gov 

by April 21, 2008. Your e-mail should 

include the following information: 

• Your name, 

• Title, 

• Business affiliation, 

• Address, 

• Telephone and fax numbers, and email address. 

Please submit a written statement at 

the time of registration, identifying by 

number each discussion question you 

wish to address and the approximate 

time requested to make your 

presentation. Organizations should 

provide this information as well as the 

names and addresses of all participants. 

Registered individuals will be notified 

of the scheduled time for their 

presentation prior to the hearing. 

Depending on the number of 

presentations, FDA may need to limit 

the time allotted for presentations. 

However, the administrative record of 

the hearing will remain open after the 

hearing, and written comments may be 

submitted to the docket as described in 

section V of this document. 

Presentations will be limited to the 

subject matter identified in section III of 

this document. 

FDA will accept walk-in registration 

at the site, but space is limited. FDA 

will try to accommodate all persons 

who wish to make a public comment at 

the hearing, including those who 

register at the site. Registration is on a 

first-come, first-served basis. 

Additionally, please notify FDA (see 

FOR FURTHER INFORMATION CONTACT) if 

you need any special accommodations 

(such as wheelchair access) at the time 

of registration. 

SUPPLEMENTARY INFORMATION: 

I. Background 

Antimicrobial drug resistance is a 

major public health concern and a threat 

to the effectiveness of existing 

antimicrobial drugs. Antimicrobial 

resistant pathogens continue to emerge 

that are very difficult to treat and that 

may cause serious or life-threatening 

diseases. Emerging antimicrobial 

resistance among many bacteria (e.g., 

Pseudomonas species, Acinetobacter 

species, Enterococcus species, 

Staphylococcus aureus, Streptococcus 

pneumoniae, and Mycobacterium 

tuberculosis) and changes in virulence 

(e.g., Clostridium difficile, group A 

Streptococci, Escherichia coli O157:H7, 

and Staphylococcus aureus) are major 

public health concerns. Timely 

development of new therapeutic agents 

is essential and use of existing therapies 

to treat infections caused by these 

organisms should be optimized to 

preserve their utility in treating 

infections and reduce the rate at which 

resistance develops. 

FDA has been working closely with 

other Government agencies and 

organizations to address the issue of 

antimicrobial resistance. An interagency 

Task Force began looking at 

antimicrobial resistance in 1999, and 

developed and published the Public 

Health Action Plan to Combat 

Antimicrobial Resistance (Action Plan) 

(available at http://www.cdc.gov/ 

drugresistance/actionplan/html/ 

index.htm).1 FDA also published a final 

rule in February 2003 that requires 

incorporation of information on 

antimicrobial resistance and prudent 

use in the labeling of systemic 

antibacterial drug products for human 

use (68 FR 6062, February 6, 2003). FDA 

has held or participated in a number of 

meetings on antimicrobial resistance, 

including an Anti-Infective Drugs 

Products Advisory Committee in March 

2003, an Infectious Diseases Society of 

America/International Society of AntiInfective Pharmacology/FDA Workshop 

on Antimicrobial Drug Development in 

April 2004, and an FDA Science Board 

Advisory Committee meeting on the 

Center for Veterinary Medicine’s 

National Antimicrobial Resistance 

Monitoring System in April 2007. 

In September 2007, Congress passed 

the Food and Drug Administration 

Amendments Act (FDAAA), which was 

signed into law by the President on 

September 27, 2007 (Public Law 110–

85). Section 1112 (Orphan Antibiotic 

Drugs) of FDAAA requires the 

Commissioner of Food and Drugs (the 

Commissioner) to convene a public 

hearing to discuss which serious and 

life-threatening infectious diseases, such 

as diseases caused by gram-negative 

bacteria and other diseases due to 

antibiotic-resistant bacteria, potentially 

qualify for available grants and contracts 

under section 5(a) of the Orphan Drug 

Act (21 U.S.C. 360ee(a)) or other 

incentives. For this reason, FDA is 

holding this public hearing. 

Under the Orphan Drug Act (Public 

Law 97–414), a drug is an orphan drug 

if it is intended for use in a rare disease 

or condition. Sponsors of orphan drugs 

are eligible for certain research and 

development incentives. During the 

period that an orphan drug is in 

development, the sponsor may be 

awarded grant funding to defray the cost 

of qualified clinical testing incurred in 

connection with the development of the 

drug for a rare disease or condition. A 

drug that has been designated as an 

orphan drug by FDA may receive 7 

years of marketing exclusivity for the 

drug for the designated orphan use upon 

approval. To receive designation as an 

orphan drug (as defined in section 526 

of the Federal Food, Drug, and Cosmetic 

Act) (21 U.S.C. 360bb)), a sponsor must 

meet the requirements in 21 CFR 316.20 


jlentini on PROD1PC65 with NOTICES
Federal Register / Vol. 73, No. 73 / Tuesday, April 15, 2008 / Notices 20311 

and 316.21. These requirements 

include, but are not limited to, 

documentation of the following: 

• The disease or condition for which 

the drug is intended affects fewer than 

200,000 people in the United States 

(e.g., tuberculosis, malaria, 

trypanosomiasis). 

• If the drug is a vaccine, diagnostic 

drug, or preventative drug, the persons 

to whom the drug will be administered 

in the United States are fewer than 

200,000 per year. 

• For a drug intended for diseases or 

conditions affecting 200,000 or more 

people, or for a vaccine, diagnostic drug, 

or preventative drug to be administered 

to 200,000 or more persons per year in 

the United States, there is no reasonable 

expectation that costs of research and 

development of the drug for the 

indication can be recovered by sales of 

the drug in the United States. 

Antimicrobial drugs that have 

qualified for orphan drug designation in 

the past include some indicated for the 

treatment of tuberculosis, malaria, and 

trypanosomiasis. 

II. Purpose and Scope of the Hearing 

This hearing is intended to provide 

the infectious disease community, 

sponsors, and other interested parties an 

opportunity to discuss their experience 

with and concerns about the emerging 

threat of antimicrobial resistance, 

possible strategies fostering prudent use 

to prevent the development of 

antimicrobial resistance, and the 

potential for the provisions of the 

Orphan Drug Act or other incentives to 

facilitate antimicrobial drug 

development, including what, if any, 

conditions might be required to 

accompany such incentives. 

III. Issues for Discussion 

FDA invites comments from 

interested parties on the following 

questions: 

1. Please discuss strategies that 

should be considered to limit the 

development of antimicrobial 

resistance, and studies that could be 

done to assess the utility, safety and 

effectiveness of those strategies. Possible 

examples include limiting the approved 

conditions of use, limiting the duration 

of therapy, restricting distribution to 

encourage appropriate use, using shorter 

courses of therapy with higher doses of 

antimicrobials, and using directly 

observed therapy. 

2. Please discuss the possible utility 

and effectiveness of economic 

incentives in promoting drug 

development for antimicrobial resistant 

organisms. 

a. What is the potential role of the 

Orphan Drug Act in providing 

incentives to facilitate antimicrobial 

drug development? Please describe the 

serious and life-threatening infectious 

diseases for which the Orphan Drug Act 

provides viable research and 

development incentives. Please 

comment on the potential complexities 

associated with identifying appropriate 

orphan populations in the infectious 

disease context. 

b. Are there specific incentives (other 

than those provided by the Orphan Drug 

Act) that could facilitate the 

development of new antimicrobial 

therapies for serious and life-threatening 

diseases? Describe those serious and 

life-threatening infectious diseases, such 

as diseases due to gram-negative 

bacteria and other diseases due to 

antimicrobial-resistant bacteria, which 

could be considered under an 

alternative incentive program. 

IV. Notice of Hearing Under 21 CFR 

Part 15 

The Commissioner is announcing that 

the public hearing will be held in 

accordance with part 15 (21 CFR part 

15). The hearing will be conducted by 

a presiding officer, accompanied by 

FDA senior management from the Office 

of the Commissioner, the Center for 

Drug Evaluation and Research, the 

Center for Biologics Evaluation and 

Research, and FDA’s Office of Orphan 

Drugs. 

Under § 15.30(f), the hearing is 

informal, and the rules of evidence do 

not apply. No participant may interrupt 

the presentation of another participant. 

Only the presiding officer and panel 

members may question any person 

during or at the conclusion of each 

presentation. 

Public hearings under part 15 are 

subject to FDA’s policy and procedures 

for electronic media coverage of FDA’s 

public administrative proceedings (part 

10 (21 CFR part 10), subpart C)). Under 

§ 10.205, representatives of the 

electronic media may be permitted, 

subject to certain limitations, to 

videotape, film, or otherwise record 

FDA’s public administrative 

proceedings, including presentations by 

participants. The hearing will be 

transcribed as stipulated in § 15.30(b). 

To the extent that the conditions for 

the hearing, as described in this notice, 

conflict with any provisions set out in 

part 15, this notice acts as a waiver of 

those provisions as specified in 21 CFR 

15.30(h). 

V. Request for Comments 

Regardless of attendance at the public 

hearing, interested persons may submit 

written or electronic comments to the 

Division of Dockets Management (see 

ADDRESSES). Submit a single copy of 

electronic comments or two paper 

copies of any mailed comments, except 

that individuals may submit one paper 

copy. Comments should be identified 

with the docket number found in 

brackets in the heading of this 

document. To ensure consideration, 

submit comments by (see DATES). 

Received comments may be seen in the 

Division of Dockets Management 

between 9 a.m. and 4 p.m., Monday 

through Friday. 

Please note that on January 15, 2008, 

the FDA Division of Dockets 

Management Web site transitioned to 

the Federal Dockets Management 

System (FDMS). FDMS is a 

Government-wide, electronic docket 

management system. Electronic 

comments or submissions will be 

accepted by FDA through FDMS only. 

VI. Transcripts 

Please be advised that as soon as a 

transcript is available, it will be 

accessible at http://www.fda.gov/ohrms/ 

dockets/ac/acmenu.htm. It may be 

viewed at the Division of Dockets 

Management (see ADDRESSES). A 

transcript will also be available in either 

hardcopy or on CD–ROM, after 

submission of a Freedom of Information 

request. Written requests are to be sent 

to Division of Freedom of Information 

(HFI–35), Office of Management 

Programs, Food and Drug 

Administration, 5600 Fishers Lane, rm. 

6–30, Rockville, MD 20857. 

Dated: April 9, 2008. 

Jeffrey Shuren, 

Associate Commissioner for Policy and 

Planning. 

[FR Doc. 08–1129 Filed 4–10–08; 12:23 pm] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Office of Inspector General 

Privacy Act of 1974, New OIG Privacy 

Act System of Records: Litigation Files 

AGENCY: Office of Inspector General 

(OIG), HHS. 

ACTION: Notice of proposed new Privacy 

Act systems of records. 

SUMMARY: The Office of Inspector 

General (OIG) is proposing a new 

system of records, entitled Litigation 

Files, Administrative Complaints, and 

Personnel Actions, HHS/OS/OIG/OCIG 

(09–90–0077). This proposed notice is 

in accordance with the Privacy Act 


jlentini on PROD1PC65 with NOTICES