Federal Register / Vol. 74, No. 10 / Thursday, January 15, 2009 / Notices 2605 

accepted by FDA only through FDMS at 

http://www.regulations.gov. 

Transcripts: Transcripts of the public 

workshop may be requested in writing 

from the Freedom of Information Office 

(HFI–35), Food and Drug 

Administration, 5600 Fishers Lane, rm. 

6–30, Rockville, MD 20857, 

approximately 15 working days after the 

public workshop at a cost of 10 cents 

per page. A transcript of the public 

workshop will be available on the 

Internet at http://www.fda.gov/cdrh/ 

ocd/udi.index.html. 

Dated: January 6, 2009. 

Jeffrey Shuren, 

Associate Commissioner for Policy and 

Planning. 

[FR Doc. E9–784 Filed 1–14–09; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2008–N–0656] 

Secure Supply Chain Pilot Program; 

Notice of Pilot Program 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing an 

opportunity for sponsors and foreign 

manufacturers of finished drug products 

and active pharmaceutical ingredients 

(APIs) intended for human use imported 

by a secure supply chain to apply to 

participate in a voluntary Secure Supply 

Chain (SSC) pilot program to be 

conducted by FDA’s Center for Drug 

Evaluation and Research (CDER) and 

Office of Regulatory Affairs (ORA). The 

goal of the pilot program is to allow 

FDA to determine the practicality of 

developing a secure supply chain 

program. The information obtained from 

this pilot program will assist FDA in its 

determination. A Secure Supply Chain 

program would assist the agency in its 

efforts to prevent the importation of 

adulterated, misbranded, or unapproved 

drugs by allowing the agency to focus its 

resources on imported drugs outside the 

program that may pose such risks. Such 

a program would increase the likelihood 

of expedited entry for specific finished 

drug products and APIs imported into 

the United States that meet the criteria 

for selection under the program. 

DATES: Submit written or electronic 

comments on this pilot program by 

March 16, 2009. Submit written or 

electronic comments on the collection 

of information by March 16, 2009. 

ADDRESSES: Submit written comments 

regarding this SSC pilot program 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. 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. Submit 

electronic comments on the collection 

of information 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: 

Kathleen Anderson, Office of 

Compliance, Division of New Drugs and 

Labeling Compliance, Food and Drug 

Administration, Center for Drug 

Evaluation and Research, 10903 New 

Hampshire Ave., Bldg. 51, rm. 5182, 

Silver Spring, MD 20993, 301–796– 

3110. 

SUPPLEMENTARY INFORMATION: 

I. Background 

The SSC pilot program is part of 

FDA’s risk-based approach to regulating 

drug imports, and it follows the 

President’s charge to the Interagency 

Working Group on Import Safety to 

better assure that imported products are 

safe. 

The goal of the pilot program is to 

allow FDA to determine the practicality 

of developing a secure supply chain 

program. The information obtained from 

this pilot program will assist FDA in its 

determination. A Secure Supply Chain 

program would assist the agency in its 

efforts to prevent the importation of 

adulterated, misbranded, or unapproved 

drugs by allowing the agency to focus its 

resources on imported drugs that fall 

outside the program and that may pose 

such risks. Such a program would 

increase the likelihood of expedited 

entry for specific finished drug products 

and APIs imported into the United 

States that meet the criteria for selection 

under the program. 

II. Definitions for the Purposes of This 

Program 

• Affirmation of Compliance (AofC) 

Code: A code designated by FDA for use 

by filers to convey information related 

to product or firm compliance with 

agency requirements, used to help 

expedite entry processing. Some AofC 

codes require a qualifier to provide 

additional information to aid in 

expedited processing. 

• Automated Broker Interface (ABI): 

An integral part of the Automated 

Commercial System, ABI is the means 

by which brokers or importers transmit 

entry data to the U.S. Customs and 

Border Protection (CBP). 

• Automated Commercial System 

(ACS): The system used by CBP to track, 

control, and process all commercial 

goods imported into the United States. 

• Broker/Customs Broker/Filer: A 

licensed Customs broker hired to file 

entries for another party or a Customs 

ABI participant that files its own 

entries. 

• Customs-Trade Partnership Against 

Terrorism (CTPAT): CTPAT is the CBP 

initiative that partners with members of 

the trade community on a voluntary 

basis to better secure the international 

product supply chain to the United 

States. 

• Foreign Shipper: The firm 

identified or declared as the shipper at 

time of entry into the United States. 

• Importer of Record: The person, 

establishment, or representative 

responsible for making entry of 

imported goods in accordance with all 

laws affecting such importation. 

• ‘‘May Proceed’’: This term means 

that an FDA-regulated imported product 

may proceed into domestic commerce 

after the electronic screening. This is 

not a decision by FDA about the 

product’s regulatory status, and it does 

not preclude FDA action at a later time. 

• Manufacturer ID (MID): 

Manufacturer identification code 

constructed with specific segments of 

the manufacturer’s or shipper’s name 

and address. Refer to CBP Customs 

Directive Number 3550–055 (Old 

Number 3500–13), dated November 24, 

1986, for instructions on determining 

the manufacturer ID. 

• Ultimate Consignee: The party in 

the United States, at the time of entry or 

release, to whom the overseas shipper 

sold the imported merchandise. If at the 

time of entry the imported merchandise 

has not been sold, then the Ultimate 

Consignee at the time of entry or release 

is defined as the party in the United 

States to whom the overseas shipper 

consigned the imported merchandise. 

III. SSC Pilot Program 

A. Description 

The SSC pilot program will be jointly 

administered by the Office of 

Compliance in CDER and the Division 

of Import Operations and Policy (DIOP) 

in ORA. To be selected to participate in 

the SSC pilot program, an application 

must meet the following criteria: 

1. The applicant must submit a 

complete application, which is Form 


jlentini on PROD1PC65 with NOTICES
2606 Federal Register / Vol. 74, No. 10 / Thursday, January 15, 2009 / Notices 

FDA–3676. An applicant must be the 

holder of the New Drug Application 

(NDA) or Abbreviated New Drug 

Application (ANDA) or the foreign 

manufacturer of the imported finished 

drug product or API. 

2. If the Ultimate Consignee identified 

in the SSC pilot application is an 

establishment subject to section 510 of 

the Federal Food, Drug, and Cosmetic 

Act (the act), then it must be in 

compliance with FDA’s registration, 

drug listing, and current good 

manufacturing practice (cGMP) 

requirements and must have been in 

compliance over the past 3 years. 

3. If the drug product identified in the 

SSC pilot application is a finished 

dosage form, then the firm identified as 

the Ultimate Consignee for the drug 

product must be identified in the NDA 

or ANDA. 

4. If the drug product identified in the 

SSC pilot application is an API, then it 

must be used in the manufacture of an 

FDA approved drug product. 

5. The importation of the finished 

drug product or API must: (a) Be from 

the foreign manufacturer identified in 

the SSC pilot application, (b) arrive 

through the identified port of entry and 

port of arrival, (c) use the identified 

Broker/Customs Broker/Filer, and (d) be 

intended for the identified Ultimate 

Consignee. 

6. The foreign manufacturer identified 

in the SSC pilot application must be in 

compliance with requirements of the act 

relating to drugs. 

7. The SSC applicant must have either 

a pending application or be certified 

with the CBP Customs-Trade 

Partnership Against Terrorism (CTPAT) 

Tier II certified secure supply chain. 

Both applicants to the SSC pilot 

program and firms identified in the SSC 

application must be CTPAT Tier II 

certified or Tier II pending certification 

at the time an application is submitted 

for participation in the pilot program. 

8. The primary and secondary 

contacts identified in the SSC 

application must be able to answer 

questions and resolve issues raised by 

FDA. 

9. The applicant must have a plan in 

place for promptly correcting any 

concerns that FDA identifies regarding 

its secure supply chain or specific 

importations. 

10. The applicant must have a 

sufficient plan in place for recalling or 

correcting any finished drug products or 

APIs that do not meet, or are discovered 

not to have been manufactured in 

accordance with, FDA requirements. 

Deviations from the recall procedures 

for products associated with the SSC 

pilot program must be reported to FDA 

within 3 business days of identification 

by the applicant. 

11. Applicants must comply with 

recordkeeping requirements of the act 

and its implementing regulations. For 

the purposes of participating in this 

pilot, applicants must make these 

records readily available to FDA upon 

request. Regardless of whether required 

by law, applicants must also maintain 

records that confirm the information 

provided in their SSC pilot applications, 

including documentation of their 

CTPAT certification status. These 

records must be maintained for the 

duration of the applicant’s participation 

in the program and be readily available 

when requested by FDA. FDA requests, 

however, that these records be 

maintained and be readily available 

when requested by FDA for a period of 

at least 3 years after the pilot ends or the 

applicant’s participation in the pilot 

ends. In addition, regardless of whether 

required by law, for each shipment of 

finished drug product or API, applicants 

must maintain records that document 

the product’s movement through the 

secure supply chain from the point of 

manufacture to the point of receipt by 

the Ultimate Consignee. These records 

must be maintained for the duration of 

the applicant’s participation in the 

program and be readily available when 

requested by FDA. 

12. The Broker/Customs Broker/Filer 

identified in the SSC pilot application 

must be qualified for paperless entry 

filing to FDA’s Operational and 

Administrative System for Import 

Support (OASIS). 

Participation in the SSC pilot program 

described in this notice is voluntary. 

FDA plans to substantially increase the 

rate at which entries of the finished 

drug products and APIs selected for the 

SSC pilot program are given a ‘‘May 

Proceed’’ without human entry review 

or examination at the time of entry. As 

with all entries, FDA will, however, 

perform full electronic entry review of 

products included in the SSC pilot 

program. Some entries covered by the 

SSC pilot program will receive further 

FDA review or examination after the 

electronic entry review. In addition, 

FDA does not intend to issue a ‘‘May 

Proceed’’ after electronic entry review if 

it has information that a problem may 

exist with the product. Nothing in this 

notice restricts FDA, CBP, or any other 

agency from examining or inspecting 

any product or establishment, or affects 

the legal responsibilities of participants 

or the legal requirements of products 

that they are importing. FDA intends to 

regularly examine records and review 

whether participants in the SSC pilot 

program continue to meet the program’s 

criteria. 

FDA will assign a qualifier (a unique 

identifier) to each selected SSC pilot 

program application, and the Broker/ 

Customs Broker/Filer will transmit the 

qualifier when filing entry for the 

product. The qualifier will accompany 

an AofC code, which FDA has 

designated as ‘‘SSC.’’ The AofC code 

identifies the drug product as being part 

of the SSC pilot program. In the event 

of any changes to the information 

contained in the SSC pilot program 

application, the pilot program applicant 

must submit a modified application 

detailing those changes and obtain FDA 

authorization of those changes in order 

to continue participation in the 

program. FDA will attempt to respond 

to the applicant’s modified application 

within 15 business days after receipt. 

The pilot program participants must 

be in full compliance with all 

requirements of the act relating to drug 

products. FDA may withdraw its 

selection of an application if the 

applicant, foreign manufacturer, or 

Ultimate Consignee receives a Warning 

Letter citing violations of the act relating 

to drug products or that FDA otherwise 

deems to have violated any 

requirements of the act relating to drug 

products. If the pilot program’s criteria 

are no longer met, FDA intends to 

withdraw its selection of the relevant 

application. Termination of 

participation in the SSC pilot program 

will result in a return to the general rate 

at which entries of the finished drug 

products and APIs are given a ‘‘May 

Proceed’’ without human entry review 

or examination at the time of entry. 

If FDA withdraws its selection of an 

application it will provide notice to the 

applicant. The applicant may provide 

information to show the program’s 

criteria are met and, upon FDA review, 

participation in the SSC pilot program 

could continue or be resumed. 

B. Selection of Participants for the Pilot 

The Secure Supply Chain application 

form may not be submitted to FDA until 

the Office of Management and Budget 

(OMB) has approved the information 

collection associated with the SSC pilot 

program (see section IV of this 

document). After OMB approval, FDA 

will accept applications to participate in 

the program and FDA will select 

qualified applications. FDA will 

announce in the Federal Register 

OMB’s approval, the date that 

applications may be submitted, and 

application submission procedures. 

FDA plans to select applications to 

participate in the SSC pilot program 

from not more than 100 qualified 


jlentini on PROD1PC65 with NOTICES
Federal Register / Vol. 74, No. 10 / Thursday, January 15, 2009 / Notices 2607 

applicants and not more than 5 drug 

products per applicant. FDA may, at its 

discretion, increase or decrease the 

number of applications that it selects or 

the number of products per applicant. 

The application to participate in the 

SSC pilot program is available for 

review and comment on the FDA Web 

site athttp://www.fda.gov/cder/fedreg/ 

fda-3676.pdf. Applications will be 

processed as they are received, on a 

first-come, first-served basis. All fields 

must be completed on the application; 

incomplete applications will be 

returned to the U.S. primary contact 

named in the application. Applicants 

will be notified in writing as to whether 

their applications have been selected. 

C. Duration of the Pilot 

The Secure Supply Chain application 

form may not be submitted to FDA until 

OMB has approved the information 

collection associated with the SSC pilot 

program. After OMB approval, FDA will 

accept applications to participate in the 

program and begin selecting 

applications for participation. FDA 

plans to finish selecting applications 

and begin the SSC pilot program 180 

days after the date FDA announces that 

it is accepting applications. FDA plans 

to continue the SSC pilot program for 2 

years after it begins. At its discretion, 

FDA may terminate the SSC pilot 

program before the close of the 2-year 

period, or FDA may extend the SSC 

pilot program beyond 2 years. Such 

decisions will be announced in the 

Federal Register. 

D. Evaluation 

FDA intends to evaluate the SSC pilot 

program based on several factors, 

including the following: Time frames for 

passage of goods through the entry 

process; the level of adherence by the 

SSC pilot program participants to the 

program’s criteria; and the impact of the 

SSC pilot program. This evaluation will 

help FDA determine whether it should 

establish an SSC program and, if so, the 

parameters of such a program. FDA may 

also determine that it should extend the 

pilot program, perhaps with 

modifications, to continue its 

evaluation. 

IV. Paperwork Reduction Act of 1995 

Under the Paperwork Reduction Act 

of 1995 (the PRA) (44 U.S.C. 3501– 

3520), Federal agencies must obtain 

approval from OMB for each collection 

of information that 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 for each proposed 

collection of information before 

submitting the collection to OMB for 

approval. To comply with this 

requirement, FDA is publishing this 

notice of the proposed collection of 

information set forth in this document. 

With respect to the collection of 

information associated with the SSC 

pilot program, FDA invites comments 

on the following topics: (1) Whether the 

proposed information collected is 

necessary for the proper performance of 

FDA’s functions, including whether the 

information will have practical utility; 

(2) the accuracy of FDA’s estimated 

burden of the proposed information 

collected, including the validity of the 

methodology and assumptions used; (3) 

ways to enhance the quality, utility, and 

clarity of the information collected; and 

(4) ways to minimize the burden of 

information collected on the 

respondents, including through the use 

of automated collection techniques, 

when appropriate, and other forms of 

information technology. 

FDA is announcing an opportunity for 

sponsors and foreign manufacturers of 

finished drug products and APIs 

intended for human use imported via a 

secure supply chain to participate in a 

voluntary SSC pilot program. A limited 

number of applications that meet 

criteria established by FDA will be 

selected by FDA based largely on 

information submitted in the Secure 

Supply Chain application. Because 

there is an information collection under 

the PRA associated with the SSC pilot 

program, FDA must first obtain OMB 

approval to collect this information 

before accepting applications to 

participate in the program and before 

selecting qualified applications. 

The information collection associated 

with the SSC pilot program consists of 

the following: 

1. Secure Supply Chain application 

form. Proposed Form FDA–3676 will 

request: 

(a) Identification and contact 

information for sponsors and foreign 

manufacturers wishing to participate in 

the SSC pilot program, (b) information 

about each drug to be imported, (c) 

logistical information associated with 

the importation and a description of the 

process by which the drug will be 

brought into the United States, and (d) 

A description of procedures that the 

applicant will follow to remedy any 

deficiencies that FDA may identify with 

the importation, including recall 

procedures. A draft of proposed Form 

FDA–3676 may be obtained at http:// 

www.fda.gov/cder/fedreg/fda–3676.pdf, 

or by calling 301–827–1482. As 

explained previously, the Secure 

Supply Chain application form may not 

be submitted to FDA until OMB has 

approved the information collection 

associated with the SSC pilot program. 

2. Changes to information contained 

in SSC pilot program. If there are 

changes to the information contained in 

the SSC pilot program application, then 

the applicant would be expected to 

submit to FDA a modified application 

detailing those changes and obtain FDA 

authorization before implementing 

them. 

3. FDA withdrawal of selection. If 

FDA withdraws its selection of an 

application from participating in the 

SSC pilot program, the applicant would 

be given an opportunity to provide 

information to FDA to show that the 

program’s criteria are met and 

participation should continue or be 

resumed. FDA will consider and act on 

this information at its sole discretion. 

4. Recordkeeping requirements. 

Applicants will be expected to maintain 

records that confirm the information 

provided in their SSC pilot program 

applications, as well as records that 

document the drugs’ movement through 

the secure supply chain from the point 

of manufacture to the point of receipt by 

the Ultimate Consignee, and make these 

records available to FDA if requested. 

FDA intends to accept applications 

from no more than 100 qualified 

applicants and no more than 5 drugs per 

applicant to participate in the SSC pilot 

program. As indicated in table 1 of this 

document, FDA estimates that no more 

than 500 Secure Supply Chain 

application forms will be submitted by 

approximately 100 applicants, and that 

it will take approximately 3.5 hours to 

complete and submit each application 

form to FDA. FDA anticipates that 

approximately 5 applicants will need to 

submit a modified Secure Supply Chain 

application form, and that each 

modified application will take 

approximately 60 minutes to complete 

and submit to FDA. FDA anticipates 

that it will need to withdraw its 

selection of only one application under 

the SSC pilot program, and that it will 

take approximately 1 hour for an 

applicant to submit information in 

response. The reporting burden 

estimated in table 1 also includes the 

time for submitting the address where 

records associated with the SSC pilot 

program will be kept, and for submitting 

the FDA assigned qualifier code and 

Affirmation of Compliance code for 

each imported drug. 


jlentini on PROD1PC65 with NOTICES
2608 Federal Register / Vol. 74, No. 10 / Thursday, January 15, 2009 / Notices 

As indicated in table 2 of this 

document, FDA estimates that 

approximately 500 records associated 

with the SSC pilot program will be kept 

by approximately 100 applicants, and 

that each record will take about 15 

minutes to maintain. 

Because FDA intends to continue the 

SSC pilot program for 2 years, these 

burden estimates are for a one-time 

burden over a 2-year period. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1.—ESTIMATED REPORTING BURDEN1

SSC Pilot Program No. of Respondents 

No. of Responses per 

Respondent Total Responses Hours per Response Total Hours 

Secure Supply Chain application 

form 100 5 500 3.5 1,750 

Modified Secure Supply Chain application form 5 1 5 60 minutes 5 

Information submitted in response 

to termination of participation 1 1 1 1 1 

Total 1,755 

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

TABLE 2.—ESTIMATED RECORDKEEPING BURDEN1

SSC Pilot Program No. of Recordkeepers 

No. of Records per 

Recordkeeper Total Records Hours per Record Total Hours 

SSC Pilot Program records 100 5 500 15 minutes 125 

Total 125 

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

V. Comments 

Interested persons may submit to the 

Division of Dockets Management (see 

ADDRESSES) written or electronic 

comments regarding this document. 

Submit a single copy of electronic 

comments or two paper copies of any 

mailed comments, except that 

individuals may submit one paper copy. 

Comments are to be identified 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. 

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 

submissions will be accepted by FDA 

through FDMS only. 

Dated: January 8, 2009. 

Jeffrey Shuren, 

Associate Comissioner for Policy and 

Planning. 

[FR Doc. E9–791 Filed 1–14–09; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Indian Health Service 

Request for Public Comment: 30-Day 

Proposed Information Collection: 

Indian Health Service Background 

Investigations of Individuals in 

Positions Involving Regular Contact 

With or Control Over Indian Children, 

OPM-306 

Correction 

In notice document E8–30330 

beginning on page 78374 in the issue of 

Monday, December 22, 2008, make the 

following correction: 

On page 78374, in the third column, 

under Form Number, in the 10th line 

‘‘IRS’’ should read ‘‘IHS’’. 

[FR Doc. Z8–30330 Filed 1–14–09; 8:45 am] 

BILLING CODE 1505–01–D 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Indian Health Service 

Request for Public Comment: 30-Day 

Proposed Information Collection: 

Indian Health Service; HIV Knowledge/ 

Attitudes/Practice Customer Survey 

Correction 

In notice document E8–30329 

beginning on page 78375 in the issue of 

Monday, December 22, 2008, make the 

following corrections: 

1. On page 78375, in the third 

column, under Proposed Collection, in 

the sixth line ‘‘IRS’’ should read ‘‘IHS’’. 

2. On the same page, in the same 

column, in the same paragraph, six lines 

from the bottom ‘‘IRS’’ should read 

‘‘IHS’’. 

3. On the same page, in the same 

column, in the last paragraph, five lines 

from the bottom ‘‘AIIAN’’ should read 

‘‘AI/AN’’. 

4. On the same page, in the same 

column, in the same paragraph, four 

lines from the bottom ‘‘lETS’’ should 

read ‘‘IHS’’. 

[FR Doc. Z8–30329 Filed 1–14–09; 8:45 am] 

BILLING CODE 1505–01–D 


jlentini on PROD1PC65 with NOTICES