69574 Federal Register / Vol. 70, No. 220 / Wednesday, November 16, 2005 / Notices 

enrollees could, because of the small 

size, use this information to deduce the 

identity of the beneficiary). 

POLICIES AND PRACTICES FOR STORING, 

RETRIEVING, ACCESSING, RETAINING, AND

DISPOSING OF RECORDS IN THE SYSTEM: 

STORAGE: 

All records are stored electronically. 

Some input may be generated in 

hardcopy, such as eligibility, 

enrollment, or other health insurance 

information before transcription to 

electronic media. 

RETRIEVABILITY: 

The collected data are retrieved by an 

individual identifier; e.g., beneficiary 

name or HIC number. 

SAFEGUARDS: 

CMS has safeguards in place for 

authorized users and monitors such 

users to ensure against excessive or 

unauthorized use. Personnel having 

access to the system have been trained 

in the Privacy Act and information 

security requirements. Employees who 

maintain records in this system are 

instructed not to release data until the 

intended recipient agrees to implement 

appropriate management, operational 

and technical safeguards sufficient to 

protect the confidentiality, integrity and 

availability of the information and 

information systems and to prevent 

unauthorized access. 

This system will conform to all 

applicable Federal laws and regulations 

and Federal, HHS, and CMS policies 

and standards as they relate to 

information security and data privacy. 

These laws and regulations include but 

are not limited to: the Privacy Act of 

1974; the Federal Information Security 

Management Act of 2002; the Computer 

Fraud and Abuse Act of 1986; the 

Health Insurance Portability and 

Accountability Act of 1996; the EGovernment Act of 2002, the ClingerCohen Act of 1996; the Medicare 

Modernization Act of 2003, and the 

corresponding implementing 

regulations. OMB Circular A–130, 

Management of Federal Resources, 

Appendix III, Security of Federal 

Automated Information Resources also 

applies. Federal, HHS, and CMS 

policies and standards include but are 

not limited to: all pertinent National 

Institute of Standards and Technology 

publications; the HHS Information 

Systems Program Handbook and the 

CMS Information Security Handbook. 

RETENTION AND DISPOSAL: 

CMS will retain information for a total 

period not to exceed 25 years. Data 

residing with the TrOOP facilitation 

contractor site agent shall be returned to 

CMS at the end of the contract period, 

with all data then being the 

responsibility of CMS for adequate 

storage and security. 

SYSTEM MANAGER AND ADDRESS: 

Henry Chao, Manager, Immediate 

Office of the Director, Office of 

Information Services, CMS, Room N3–

19–23, 7500 Security Boulevard, 

Baltimore, Maryland 21244–1850. 

NOTIFICATION PROCEDURE: 

For the purpose of access, the subject 

individual should write to the system 

manager who will require the system 

name, address, age, gender type, and, for 

verification purposes, the subject 

individual’s name (woman’s maiden 

name, if applicable). 

RECORD ACCESS PROCEDURE: 

For the purpose of access, use the 

same procedures outlined in 

Notification Procedures above. 

Requestors should also reasonably 

specify the record contents being 

sought. (These procedures are in 

accordance with Department regulation 

45 CFR, parts 160, 162, and 164.) 

CONTESTING RECORDS PROCEDURES: 

The subject individual should contact 

the system manager named above and 

reasonably identify the records and 

specify the information to be contested. 

State the corrective action sought and 

the reasons for the correction with 

supporting justification. (These 

procedures are in accordance with 

Department regulation 45 CFR 5b.7). 

SYSTEMS EXEMPTED FROM CERTAIN PROVISIONS

OF THE ACT: 

None. 

[FR Doc. 05–22657 Filed 11–15–05; 8:45 am] 

BILLING CODE 4120–03–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. 2005N–0425] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; General 

Administrative Procedures: Citizen 

Petitions; Petition for Reconsideration 

or Stay of Action; Advisory Opinions 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing an 

opportunity for public comment on the 

proposed collection of certain 

information by the agency. Under the 

Paperwork Reduction Act of 1995 (the 

PRA), Federal agencies are required to 

publish notice in the Federal Register 

concerning each proposed collection of 

information, including each proposed 

extension of an existing collection of 

information, and to allow 60 days for 

public comment in response to the 

notice. This notice solicits comments on 

the reporting requirements contained in 

existing FDA regulations regarding the 

general administrative procedures for a 

person to take the following actions: 

Petition the Commissioner of Food and 

Drugs (the Commissioner) to issue, 

amend, or revoke a rule; file a petition 

for an administrative reconsideration or 

an administrative stay of action; and 

request an advisory opinion from the 

Commissioner. 

DATES: Submit written or electronic 

comments on the collection of 

information by January 17, 2006. 

ADDRESSES: Submit electronic 

comments on the collection of 

information to: http://www.fda.gov/ 

dockets/ecomments. Submit written 

comments on the collection of 

information to the Division of Dockets 

Management (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, rm. 

1061, Rockville, MD 20852. All 

comments should be identified with the 

docket number found in brackets in the 

heading of this document. 

FOR FURTHER INFORMATION CONTACT: 

Jonna Capezzuto, Office of Management 

Programs (HFA–250), Food and Drug 

Administration, 5600 Fishers Lane, 

Rockville, MD 20857, 301–827–4659. 

SUPPLEMENTARY INFORMATION: Under the 

PRA (44 U.S.C. 3501–3520), Federal 

agencies must obtain approval from the 

Office of Management and Budget 

(OMB) for each collection of 

information they conduct or sponsor. 

‘‘Collection of information’’ is defined 

in 44 U.S.C. 3502(3) and 5 CFR 

1320.3(c) and includes agency requests 

or requirements that members of the 

public submit reports, keep records, or 

provide information to a third party. 

Section 3506(c)(2)(A) of the PRA (44 

U.S.C. 3506(c)(2)(A)) requires Federal 

agencies to provide a 60-day notice in 

the Federal Register concerning each 

proposed collection of information, 

including each proposed extension of an 

existing collection of information, 

before submitting the collection to OMB 

for approval. To comply with this 

requirement, FDA is publishing notice 

of the proposed collection of 

information set forth in this document. 

With respect to the following 

collection of information, FDA invites 

Federal Register / Vol. 70, No. 220 / Wednesday, November 16, 2005 / Notices 69575 

comments on these topics: (1) Whether 

the proposed collection of information 

is necessary for the proper performance 

of FDA’s functions, including whether 

the information will have practical 

utility; (2) the accuracy of FDA’s 

estimate of the burden of the proposed 

collection of information, including the 

validity of the methodology and 

assumptions used; (3) ways to enhance 

the quality, utility, and clarity of the 

information to be collected; and (4) 

ways to minimize the burden of the 

collection of information on 

respondents, including through the use 

of automated collection techniques, 

when appropriate, and other forms of 

information technology. 

General Administrative Procedures: 

Citizen Petitions; Petition for 

Reconsideration or Stay of Action; 

Advisory Opinions—(21 CFR Part 10) 

(OMB Control Number 0910–0183)—

Extension 

The Administrative Procedures Act (5 

U.S.C. 553(e)), provides that every 

agency shall give an interested person 

the right to petition for issuance, 

amendment, or repeal of a rule. Under 

part 10 (21 CFR part 10), § 10.30 sets 

forth the format and procedures by 

which an interested person may submit 

to FDA, in accordance with § 10.20 

(submission of documents to the 

Division of Dockets Management), a 

citizen petition requesting the 

Commissioner to issue, amend, or 

revoke a regulation or order, or to take 

or refrain from taking any other form of 

administrative action. 

The Commissioner may grant or deny 

such a petition, in whole or in part, and 

may grant such other relief or take other 

action as the petition warrants. 

Respondents are individuals or 

households, State or local governments, 

not-for-profit institutions, and 

businesses or other for-profit 

institutions or groups. 

Section 10.33, issued under section 

701(a) of the Federal, Food, Drug, and 

Cosmetic Act (the act) (21 U.S.C. 

371(a)), sets forth the format and 

procedures by which an interested 

person may request reconsideration of 

part or all of a decision of the 

Commissioner in a petition submitted 

under § 10.25 (initiation of 

administrative proceedings). A petition 

for reconsideration must contain in a 

well-organized format a full statement of 

the factual and legal grounds upon 

which the petition relies. The grounds 

must demonstrate that relevant 

information and views contained in the 

administrative record were not 

previously or not adequately considered 

by the Commissioner. The respondent 

must submit a petition no later than 30 

days after the decision has been made. 

However, the Commissioner may, for 

good cause, permit a petition to be filed 

after 30 days. An interested person who 

wishes to rely on information or views 

not included in the administrative 

record shall submit them with a new 

petition to modify the decision. FDA 

uses the information provided in the 

request to determine whether to grant 

the petition for reconsideration. 

Respondents to this collection of 

information are individuals or 

households, State or local governments, 

not-for-profit institutions, and 

businesses or other for-profit 

institutions who are requesting a 

reconsideration of a matter from the 

Commissioner. 

Section 10.35, issued under section 

701(a) of the act, sets forth the format 

and procedures by which an interested 

person may request, in accordance with 

§ 10.20 (submission of documents to 

Division of Dockets Management), the 

Commissioner to stay the effective date 

of any administrative action. 

Such a petition must provide the 

following information: (1) The decision 

involved; (2) the action requested, 

including the length of time for which 

a stay is requested; and (3) a statement 

of the factual and legal grounds on 

which the interested person relies in 

seeking the stay. FDA uses the 

information provided in the request to 

determine whether to grant the petition 

for a stay of action. Respondents to this 

information collection are interested 

persons who choose to file a petition for 

an administrative stay of action. 

Section 10.85, issued under section 

701(a) of the act, sets forth the format 

and procedures by which an interested 

person may request, in accordance with 

§ 10.20 (submission of documents to the 

Division of Dockets Management), an 

advisory opinion from the 

Commissioner on a matter of general 

applicability. An advisory opinion 

represents the formal position of FDA 

on a matter of general applicability. 

When making a request, the petitioner 

must provide a concise statement of the 

issues and questions on which an 

opinion is requested, and a full 

statement of the facts and legal points 

relevant to the request. Respondents to 

this collection of information are 

interested persons seeking an advisory 

opinion from the Commissioner on the 

agency’s formal position for matters of 

general applicability. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1

21 CFR Section No. of 

Respondents 

Annual Frequency 

per Response 

Total Annual 

Responses 

Hours per 

Response Total Hours 

10.30 156 3 468 12 5,616 

10.33 10 2 20 10 200 

10.35 13 2 26 10 260 

10.85 2 1 2 16 32 

Total 6,108 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 

The burden estimates for this 

collection of information are based on 

agency records and experience over the 

past 3 years. Agency personnel handling 

the petitions regarding § 10.30 received 

approximately 156 citizen petitions 

annually, each required an average of 12 

hours of preparation time. The agency 

received approximately 10 requests 

annually regarding § 10.33 

(administrative reconsideration of an 

action), each required an average of 10 

hours of preparation time. Regarding 

§ 10.35 (administrative stay of an 

action), the agency received 

approximately 13 requests annually, 

each required an average of 10 hours of 

preparation time. Lastly, regarding 

69576 Federal Register / Vol. 70, No. 220 / Wednesday, November 16, 2005 / Notices 

petitions for § 10.85 (advisory opinions), 

the agency received approximately 2 

requests annually, each required an 

average of 16 hours of preparation time. 

Dated: November 8, 2005. 

Jeffrey Shuren, 

Assistant Commissioner for Policy. 

[FR Doc. 05–22668 Filed 11–15–05; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. 2005N–0290] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Importer’s Entry 

Notice 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing 

that a proposed collection of 

information has been submitted to the 

Office of Management and Budget 

(OMB) for review and clearance under 

the Paperwork Reduction Act of 1995. 

DATES: Fax written comments on the 

collection of information by December 

16, 2005. 

ADDRESSES: OMB is still experiencing 

significant delays in the regular mail, 

including first class and express mail, 

and messenger deliveries are not being 

accepted. To ensure that comments on 

the information collection are received, 

OMB recommends that comments be 

faxed to the Office of Information and 

Regulatory Affairs, OMB, Attn: Fumie 

Yokota, Desk Officer for FDA, FAX: 

202–395–6974. 

FOR FURTHER INFORMATION CONTACT: 

Peggy Robbins, Office of Management 

Programs (HFA–250), Food and Drug 

Administration, 5600 Fishers Lane, 

Rockville, MD 20857, 301–827–1223. 

SUPPLEMENTARY INFORMATION: In 

compliance with 44 U.S.C. 3507, FDA 

has submitted the following proposed 

collection of information to OMB for 

review and clearance. 

Importer’s Entry Notice—(OMB Control 

Number 0910–0046)—Extension 

Section 801 of the Federal Food, Drug, 

and Cosmetic Act (the act) (21 U.S.C. 

381) charges FDA with the following 

responsibilities: (1) Ensuring that 

foreign-origin FDA-regulated foods, 

drugs, cosmetics, medical devices, and 

radiological health products offered for 

import into the United States meet the 

same requirements of the act as do 

domestic products; and (2) preventing 

shipments from entering the country if 

they are not in compliance. 

The information collected by FDA 

consists of the following: (1) Product 

code, an alpha-numeric series of 

characters that identifies each product 

FDA regulates; (2) FDA country of 

origin, the country where the FDAregistered or FDA-responsible firm is 

located; (3) FDA manufacturer, the party 

who manufactured, grew, assembled, or 

otherwise processed the goods (if more 

than one, the last party who 

substantially transformed the product); 

(4) shipper, the party responsible for 

packing, consolidating, or arranging the 

shipment of goods to their final 

destinations; (5) quantity and value of 

the shipment; and (6) if appropriate, 

affirmation of compliance, a code that 

conveys specific FDA information, such 

as registration number, foreign 

government certification, etc. This 

information is collected electronically 

by the entry filer via the U.S. Customs 

Service’s Automated Commercial 

System at the same time that person 

files an entry for import with the U.S. 

Custom Service. FDA uses this 

information to make admissibility 

decisions about FDA-regulated products 

offered for import into the United 

States. 

The annual reporting burden is 

derived from the basic processes and 

procedures used in fiscal year (FY) 

1995. The total number of entries 

submitted to the automated system in 

FY 2004 was 6,626,827. The total 

number of entries less the disclaimer 

entries will represent the total FDA 

products entered into the automated 

system. A total of 53 percent of all 

entries entered into the automated 

system were entries dealing with FDAregulated products. The number of 

respondents is a count of filers who 

submit entry data for foreign-origin 

FDA-regulated products. The estimated 

reporting burden is based on 

information obtained by FDA while 

contacting potential respondents. 

Disclaimer entries are not FDA 

commodities. 

In the Federal Register of August 3, 

2005 (70 FR 44656), FDA published a 

60-day notice requesting public 

comment on the information collection 

provisions. One comment was received. 

The Government of Canada is 

concerned that the methodology used 

does not take into consideration the 

additional burden of FDA’s interim final 

prior notice and regulation rules which 

came into effect December 2003. They 

urged FDA to amend the methodology 

used to take into consideration the 

additional burden associated with all 

requirements for providing information 

concerning foreign-origin FDA-regulated 

foods. Of particular concern is the 

burden resulting from the 

implementation of the prior notice and 

regulation rules under the Public Health 

Security and Bioterrorism Preparedness 

and Response Act of 2002. 

The burden for the prior notice and 

regulation rules is reported and 

approved under OMB Control Number 

0910–0520; expiration date October 31, 

2006. 

FDA estimates the burden of the 

collection of information as follows: 

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1

21 U.S.C. Section No. of 

Respondents 

Annual Frequency 

per Response 

Total Annual 

Responses 

Hours per 

Response Total Hours 

801 3,406 1,089 3,709,134 .14 519,279 

1There are no capital costs or operating and maintenance costs associated with this collection of information.