45014 Federal Register / Vol. 73, No. 149 / Friday, August 1, 2008 / Notices 

insurance; and (3) Workers’

compensation laws or plans. 

As indicated, the Secretary has 

elected to implement this provision by 

publishing instructions at a Web site 

established for such purpose. The Web 

site is http://www.cms.hhs.gov/ 

MandatoryInsRep/. CMS shall use this 

Web site to publish preliminary 

guidance as well as the final 

instructions. The Web site also advises 

interested parties how to comment on 

the preliminary guidance. Form 

Number: CMS–10265 (OMB# 0938–

New); Frequency: Yearly; Affected 

Public: Business or other for-profits, 

Not-for-profit institutions and State, 

Local or Tribal Governments; Number of 

Respondents: 290,404; Total Annual 

Responses: 6,920,504; Total Annual 

Hours: 2,120,478. 

To obtain copies of the supporting 

statement and any related forms for the 

proposed paperwork collections 

referenced above, access CMS’ Web Site 

at http://www.cms.hhs.gov/ 

PaperworkReductionActof1995, or email your request, including your 

address, phone number, OMB number, 

and CMS document identifier, to 

Paperwork@cms.hhs.gov, or call the 

Reports Clearance Office on (410) 786–

1326. 

In commenting on the proposed 

information collections please reference 

the document identifier or OMB control 

number. To be assured consideration, 

comments and recommendations must 

be submitted in one of the following 

ways by September 30, 2008: 

1. Electronically. You may submit 

your comments electronically to http:// 

www.regulations.gov. Follow the 

instructions for ‘‘Comment or 

Submission’’ or ‘‘More Search Options’’

to find the information collection 

document(s) accepting comments. 

2. By regular mail. You may mail 

written comments to the following 

address: CMS, Office of Strategic 

Operations and Regulatory Affairs, 

Division of Regulations Development, 

Attention: Document Identifier/OMB 

Control Number___, Room C4–26–05, 

7500 Security Boulevard, Baltimore, 

Maryland 21244–1850. 

Dated: July 2, 2008. 

Michelle Shortt, 

Director, Regulations Development Group, 

Office of Strategic Operations and Regulatory 

Affairs. 

[FR Doc. E8–17731 Filed 7–31–08; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2008–N–0420] 

Medical Device User Fee Rates for 

Fiscal Year 2009 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is publishing the 

fee rates and payment procedures for 

medical device user fees for fiscal year 

(FY) 2009. The Federal Food, Drug, and 

Cosmetic Act (the act), as amended by 

the Medical Device User Fee and 

Modernization Act of 2002 (MDUFMA), 

the Medical Device User Fee 

Stabilization Act of 2005 (MDUFSA), 

and the Medical Device User Fee 

Amendments of 2007 (Title II of the 

Food and Drug Administration 

Amendments Act of 2007 (FDAAA)), 

authorizes FDA to collect user fees for 

certain medical device submissions, and 

annual fees both for certain periodic 

reports and for certain establishments 

subject to registration. The FY 2009 fee 

rates are provided in this notice. These 

fees apply from October 1, 2008, 

through September 30, 2009. To avoid 

delay in the review of your application, 

you should pay the fee before or at the 

time you submit your application to 

FDA. The fee you must pay is the fee 

that is in effect on the later of the date 

that your application is received by FDA 

or the date your fee payment is received. 

If you want to pay a reduced small 

business fee, you must qualify as a small 

business before you make your 

submission to FDA; if you do not 

qualify as a small business before you 

make your submission to FDA, you will 

have to pay the higher standard fee. 

This notice provides information on 

how the fees for FY 2009 were 

determined, the payment procedures 

you should follow, and how you may 

qualify for reduced small business fees. 

FOR FURTHER INFORMATION CONTACT: For 

information on MDUFMA: Visit FDA’s 

Web site, http://www.fda.gov/cdrh/ 

mdufma. 

For questions relating to this notice: 

David Miller, Office of Financial 

Management (HFA–100), Food and Drug 

Administration, 5600 Fishers Lane, 

Rockville, MD 20857, 301–827–3917. 

SUPPLEMENTARY INFORMATION: 

I. Background 

Section 738 of the act (21 U.S.C. 379j) 

establishes fees for certain medical 

device applications, submissions, 

supplements, and notices (for 

simplicity, this notice refers to these 

collectively as ‘‘submissions’’); for 

periodic reporting on class III devices; 

and for the registration of certain 

establishments. Under statutorilydefined conditions, a qualified 

applicant may receive a fee waiver or 

may pay a lower small business fee (see 

21 U.S.C. 379j(d) and (e)). 

Under the act, the fee rate for each 

type of submission is set at a specified 

percentage of the standard fee for a 

premarket application (a premarket 

application is a premarket approval 

application (PMA), a product 

development protocol (PDP), or a 

biologics licensing application (BLA)). 

The act specifies the standard fee for a 

premarket application for each year 

from FY 2008 through FY 2012; the 

standard fee for a premarket application 

received by FDA during FY 2009 is 

$200,725. From this starting point, this 

notice establishes FY 2009 fee rates for 

other types of submissions, and for 

periodic reporting, by applying criteria 

specified in the act. 

The act specifies the annual fee for 

establishment registration for each year 

from FY 2008 through FY 2012; the 

registration fee for FY 2009 is $1,851. 

There is no reduction in the registration 

fee for small businesses. An 

establishment must pay the registration 

fee if it is any of the following types of 

establishments: 

• Manufacturer. An establishment 

that makes by any means any article that 

is a device, including an establishment 

that sterilizes or otherwise makes such 

article for or on behalf of a specification 

developer or any other person. 

• Single-Use Device Reprocessor. An 

establishment that performs 

manufacturing operations on a singleuse device that has previously been 

used on a patient. 

• Specification Developer. An 

establishment that develops 

specifications for a device that is 

distributed under the establishment’s 

name but which performs no 

manufacturing, including an 

establishment that, in addition to 

developing specifications, also arranges 

for the manufacturing of devices labeled 

with another establishment’s name by a 

contract manufacturer. 

The fees for FY 2009 go into effect on 

October 1, 2008, and will remain in 

effect through September 30, 2009. 

II. Fees for FY 2009 

Under the act, all submission fees and 

the periodic reporting fee are set as a 

percent of the standard (full) fee for a 

premarket application (see 21 U.S.C. 

379j(a)(2)(A)), and the act sets the 

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Federal Register / Vol. 73, No. 149 / Friday, August 1, 2008 / Notices 45015 

standard fee for a premarket application, 

including a biologic licensing 

application (BLA) and a premarket 

report, at $200,725 for FY 2009 (see 21 

U.S.C. 379j(b); this is referred to as the 

‘‘base fee’’). The fees set by reference to 

the base fee are—

• For a panel-track supplement, 75 

percent of the base fee; 

• For a 180-day supplement, 15 

percent of the base fee; 

• For a real-time supplement, 7 

percent of the base fee; 

• For a 30-day notice, 1.6 percent of 

the base fee; 

• For a 510(k) premarket notification, 

1.84 percent of the base fee; 

• For a 513(g) request for 

classification information, 1.35 percent 

of the base fee; and 

• For an annual fee for periodic 

reporting concerning a class III device, 

3.5 percent of the base fee. 

For all submissions other than a 

510(k) premarket notification, a 30-day 

notice, and a 513(g) request for 

classification information, the small 

business fee is 25 percent of the 

standard (full) fee (see 21 U.S.C. 

379j(d)(2)(C)). For a 510(k) premarket 

notification submission, a 30-day notice, 

and a 513(g) request for classification 

information, the small business fee is 50 

percent of the standard (full) fee (see 21 

U.S.C. 379j(e)(2)(C)). There is no small 

business rate for the annual 

establishment registration fee; all 

establishments pay the same fee. Table 

1 of this document sets out the FY 2009 

rates for all medical device fees. 

TABLE 1—MEDICAL DEVICE FEES FOR FY 2009 

Application Fee Type 

Standard Fee, as a Percent of the Standard 

Fee for a Premarket 

Application 

FY 2009 

Standard Fee 

FY 2009 Small 

Business Fee 

Premarket application (a PMA submitted under section 515(c)(1) of the act (21 

U.S.C. 360e(c)(1)), a PDP submitted under section 515(f) of the act, or a BLA 

submitted under section 351 of the Public Health Service (PHS) Act (42 U.S.C. 

262)) Set in statute $200,725 $50,181 

Premarket report (submitted under section 515(c)(2) of the act) 100 % $200,725 $50,181 

Efficacy supplement (to an approved BLA under section 351 of the PHS Act) 100 % $200,725 $50,181 

Panel-track supplement 75 % $150,544 $37,636 

180-day supplement 15 % $30,109 $7,527 

Real-time supplement 7 % $14,051 $3,513 

510(k) premarket notification submission 1.84 % $3,693 $1,847 

30-day notice 1.6 % $3,212 $1,606 

513(g) request for classification information 1.35 % $2,710 $1,355 

Annual Fee Type 

Annual fee for periodic reporting on a class III device 3.5 % $7,025 $1,756 

Annual establishment registration fee (to be paid by each establishment that is a 

manufacturer, a single-use device reprocessor, or a specification developer, as 

defined by 21 U.S.C. 379i(13)) Set in statute $1,851 $1,851 

III. How to Qualify as a Small Business 

for Purposes of Medical Device Fees 

If your business has gross receipts or 

sales of no more than $100 million for 

the most-recent tax year, you may 

qualify for reduced small business fees. 

If your business has gross sales or 

receipts of no more than $30 million, 

you may also qualify for a waiver of the 

fee for your first premarket application 

(PMA, PDP, or BLA) or premarket 

report. You must include the gross 

receipts or sales of all of your affiliates 

along with your own gross receipts or 

sales when determining whether you 

meet the $100 million or $30 million 

threshold. If you want to pay the small 

business fee rate for a submission, or 

you want to receive a waiver of the fee 

for your first premarket application or 

premarket report, you should submit the 

materials showing you qualify as a small 

business 60 days before you send your 

submission to FDA. If you make a 

submission before FDA finds that you 

qualify as a small business, you must 

pay the standard fee for that submission. 

If your business qualified as a small 

business for FY 2008, your status as a 

small business will expire at the close 

of business on September 30, 2008. You 

must re-qualify for FY 2009 in order to 

pay small business fees during FY 2009. 

If you are a domestic (U.S.) business, 

and wish to qualify as a small business 

for FY 2009, you must submit the 

following to FDA: 

(1) A completed FY 2009 MDUFMA 

Small Business Qualification 

Certification (Form FDA 3602). This 

form is provided in FDA’s guidance 

document, ‘‘FY 2009 Medical Device 

User Fee Small Business Qualification 

and Certification,’’ available on FDA’s 

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

mdufma. This form is not available 

separate from the guidance document. 

(2) A certified copy of your Federal 

(U.S.) Income Tax Return for the most 

recent tax year. The most recent tax year 

will be 2008, except—

• If you submit your FY 2009 

MDUFMA Small Business Qualification 

before April 15, 2009, and you have not 

yet filed your return for 2008, you may 

use tax year 2007. 

• If you submit your FY 2009 

MDUFMA Small Business Qualification 

on or after April 15, 2008, and have not 

yet filed your 2008 return because you 

obtained an extension, you may submit 

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45016 Federal Register / Vol. 73, No. 149 / Friday, August 1, 2008 / Notices 

your most-recent return filed prior to 

the extension. 

(3) For each of your affiliates, either—

• If the affiliate is a domestic (U.S.) 

business, a certified copy of the 

affiliate’s Federal (U.S.) income tax 

return for the most recent tax year, or 

• If the affiliate is a foreign business 

and cannot submit a Federal (U.S.) 

Income Tax Return, a National Taxing 

Authority Certification completed by, 

and bearing the official seal of, the 

National Taxing Authority of the 

country in which the firm is 

headquartered. This certification must 

show the amount of gross receipts or 

sales for the most recent tax year, in 

both U.S. dollars and the local currency 

of the country, the exchange rate used 

in converting the local currency to U.S. 

dollars, and the dates of the gross 

receipts or sales collected. The 

applicant should also submit a 

statement signed by the head of the 

applicant’s firm or by its chief financial 

officer that the applicant has submitted 

certifications for all of its affiliates, 

identifying the name(s) of each 

affiliate(s), or that the applicant has no 

affiliates. The National Taxing 

Authority is the foreign equivalent of 

the U.S. Internal Revenue Service. 

If you are a foreign business, and wish 

to qualify as a small business for FY 

2009, you must submit the following: 

(1) A completed FY 2009 MDUFMA 

Foreign Small Business Qualification 

Certification (Form FDA 3602A). This 

form is provided in FDA’s guidance 

document, ‘‘FY 2009 Medical Device 

User Fee Small Business Qualification 

and Certification,’’ available on FDA’s 

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

mdufma. This form is not available 

separate from the guidance document. 

(2) A National Taxing Authority 

Certification, completed by, and bearing 

the official seal of, the National Taxing 

Authority of the country in which the 

firm is headquartered. This Certification 

must show the amount of gross receipts 

or sales for the most recent tax year, in 

both U.S. dollars and the local currency 

of the country, the exchange rate used 

in converting the local currency to U.S. 

dollars, and the dates of the gross 

receipts or sales collected. 

(3) For each of your affiliates, either—

• If the affiliate is a domestic (U.S.) 

business, a certified copy of the 

affiliate’s Federal (U.S.) Income Tax 

Return for the most recent tax year 

(2007 or later), or 

• If the affiliate is a foreign business 

and cannot submit a Federal (U.S.) 

Income Tax Return, a National Taxing 

Authority Certification completed by, 

and bearing the official seal of, the 

National Taxing Authority of the 

country in which the firm is 

headquartered. This certification must 

show the amount of gross receipts or 

sales for the most recent tax year, in 

both U.S. dollars and the local currency 

of the country, the exchange rate used 

in converting the local currency to U.S. 

dollars, and the dates for the gross 

receipts or sales collected. The 

applicant should also submit a 

statement signed by the head of the 

applicant’s firm or by its chief financial 

officer that the applicant has submitted 

certifications for all of its affiliates, 

identifying the name(s) of each 

affiliate(s), or that the applicant has no 

affiliates. The National Taxing 

Authority is the foreign equivalent of 

the U.S. Internal Revenue Service. 

IV. Procedures for Paying Application 

and Annual Report Fees 

If your application or submission is 

subject to a fee and is received by FDA 

from October 1, 2008 through 

September 30, 2009, you must pay the 

fee in effect for FY 2009. The later of the 

date that the application or annual 

report is received in the reviewing 

center’s document room or the date that 

the check is received by U.S. Bank 

determines whether the fee rates for FY 

2008 or FY 2009 apply. FDA must 

receive the correct fee at the time that 

an application or annual report is 

submitted, or the application or annual 

report will not be accepted for filing or 

review. 

FDA requests that you follow the 

steps below before submitting a medical 

device application or annual report 

subject to a fee. Please pay close 

attention to these procedures to ensure 

that FDA links the fee with the correct 

application. (Note: In no case should the 

check for the fee be submitted to FDA 

with the application.) 

A. Step One—Secure a Payment 

Identification Number (PIN) and 

Medical Device User Fee Cover Sheet 

From FDA Before Submitting Either the 

Application or the Payment (Note: Both 

the FY 2008 and FY 2009 fee rates will 

be available on the Cover Sheet Web 

Site beginning on the date of 

publication of this notice, and the FY 

2008 rates will no longer appear after 

September 30, 2008.) 

Log onto the MDUFMA Web site at 

http://www.fda.gov/oc/mdufma and, 

under the forms heading, click on the 

link ‘‘User Fee Cover Sheet.’’ Complete 

the Medical Device User Fee Cover 

Sheet. Be sure you choose the correct 

application submission date range. (Two 

choices will be offered until October 1, 

2008. One choice is for applications that 

will be received on or before September 

30, 2008, which will be subject to FY 

2008 fee rates. A second choice is for 

applications that will be received on or 

after October 1, 2008, which will be 

subject to FY 2009 fee rates.) After 

completing data entry, print a copy of 

the Medical Device User Fee Cover 

Sheet and note the unique PIN located 

in the upper right-hand corner of the 

printed cover sheet. 

B. Step Two—Electronically Transmit a 

Copy of the Printed Cover Sheet With 

the PIN to FDA’s Office of Financial 

Management 

Once you are satisfied that the data on 

the cover sheet is accurate, 

electronically transmit that data to FDA 

according to instructions on the screen. 

Since electronic transmission is 

possible, applicants are required to set 

up a user account and use passwords to 

assure data security in the creation and 

electronic submission of cover sheets. 

C. Step Three—Mail Payment and a 

Copy of the Completed Medical Device 

User Fee Cover Sheet to the St. Louis 

Address Specified in This Section 

• Make the payment in U. S. currency 

by check, bank draft, or U.S. Postal 

money order payable to the Food and 

Drug Administration. (FDA’s tax 

identification number is 53–0196965, 

should your accounting department 

need this information.) 

• Please write your application’s 

unique PIN, from the upper right-hand 

corner of your completed Medical 

Device User Fee Cover Sheet, on your 

check, bank draft, or U.S. Postal money 

order. 

• Mail the payment and a copy of the 

completed Medical Device User Fee 

Cover Sheet to: Food and Drug 

Administration, P.O. Box 956733, St. 

Louis, MO, 63195–6733. 

(Note: This address is for payments of 

application and annual report fees only 

and is not to be used for payment of 

annual establishment registration fees.) 

If you prefer to send a check by a 

courier (such as FEDEX, DHL, UPS, 

etc.), the courier may deliver the check 

to: U.S. Bank, Attn: Government 

Lockbox 956733, 1005 Convention 

Plaza, St. Louis, MO 63101. 

(Note: This address is for courier 

delivery only. Contact the U.S. Bank at 

314–418–4821 if you have any questions 

concerning courier delivery.) 

It is helpful if the fee arrives at the 

bank at least 1 day before the 

application arrives at FDA. FDA records 

the official application receipt date as 

the later of the following: 

• The date the application was 

received by FDA. 

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Federal Register / Vol. 73, No. 149 / Friday, August 1, 2008 / Notices 45017 

• The date U.S. Bank receives the 

payment. U.S. Bank is required to notify 

FDA within 1 working day, using the 

PIN described previously in this 

document. 

D. Step Four—Submit Your Application 

to FDA With a Copy of the Completed 

Medical Device User Fee Cover Sheet 

Please submit your application and a 

copy of the completed Medical Device 

User Fee Cover Sheet to one of the 

following addresses: 

• Medical device applications should 

be submitted to: Food and Drug 

Administration, Center for Devices and 

Radiological Health, Document Mail 

Center (HFZ–401), 9200 Corporate 

Blvd., Rockville, MD 20850. 

• Biologic applications should be sent 

to: Food and Drug Administration, 

Center for Biologics Evaluation and 

Research, Document Control Center 

(HFM–99), suite 200N, 1401 Rockville 

Pike, Rockville, MD 20852–1448. 

V. Procedures for Paying Annual 

Establishment Fees 

If you are required to pay an annual 

establishment registration fee, you must 

pay for each establishment prior to 

registration. Payment must be submitted 

by first creating a Device Facility Use 

Fee (DFUF) order through the User Fee 

Web site at https://fdasfinapp8.fda.gov/ 

OA_HTML/fdaCAcdLogin.jsp. You will 

be issued a PIN once you place your 

order. After payment has been 

processed, you will be issued a payment 

confirmation number (PCN). You will 

not be able to register your 

establishment if you do not have a PIN 

and a PCN. An establishment required 

to pay an annual establishment 

registration fee is not legally registered 

in FY 2009 until it has completed the 

steps in this section to register and pay 

any applicable fee (see 21 U.S.C. 

379j(f)(2)). 

A. Step One—Submit a Device Facility 

User Fee Order With a PIN From FDA 

Before Registering or Submitting 

Payment 

To submit a DFUF order, you must 

create or have previously created a user 

account and password for the User Fee 

Web site listed in this section. After 

creating a user name and password, log 

onto the Annual Facility User Fee 2009 

store. Complete the DFUF order by 

entering the number of establishments 

you are registering. Once you are 

satisfied that the data on the order is 

accurate, electronically transmit that 

data to FDA according to instructions on 

the screen. Print a copy of the final 

DFUF order and note the unique PIN 

located in the upper right-hand corner 

of the printed order. 

B. Step Two—Pay for Your DFUF Order 

Unless paying by credit card, all 

payments must be in U. S. currency and 

drawn on a U.S. bank. The DFUF order 

will include payment information, 

including details on how you can pay 

online using a credit card or electronic 

checks. Follow the instructions 

provided to make an electronic 

payment. If you prefer not to pay online, 

you may pay by a check, in U.S. dollars 

and drawn on a U.S. bank, mailed to: 

Food and Drug Administration, P.O. 

Box 70961, Charlotte, NC 28272–0961. 

(Note: This address is different from the 

address for payments of application and 

annual report fees and is to be used only 

for payment of annual establishment 

registration fees.) 

If a check is sent by a courier that 

requests a street address, the courier can 

deliver the check to: Wachovia Bank, 

Attn: Food and Drug Administration—

Lockbox 70961, rm. NC0810, 1525 West 

WT Harris Blvd., Charlotte, NC 28262. 

(Note: This Wachovia Bank address is 

for courier delivery only; do not send 

mail to this address.) 

Please make sure that both of the 

following numbers are written on your 

check: (1) The FDA post office box 

number (P.O. Box 70961), and (2) the 

PIN that is printed on your order. A 

copy of your printed order should also 

be mailed along with your check. FDA’s 

tax identification number is 53–

0196965. 

Wire transfers may also be used to pay 

annual establishment fees. For wire 

transfer information, please contact the 

user fee helpdesk at 301–827–9539 or 

userfees@fda.gov. 

C. Step Three—Complete the 

Information Online to Update Your 

Establishment’s Annual Registration for 

FY 2009, or to Register a New 

Establishment for FY 2009 

Go to CDRH’s Web site at http:// 

www.fda.gov/cdrh/reglistpage.html and 

click the ‘‘Electronic Registration and 

Listing System (FURLS)’’ link on the left 

of the page. This opens up a new page 

with important information about 

FURLS. After reading this information 

click on the link at the bottom of the 

page. That takes you to an FDA Industry 

Systems page with tutorials that 

demonstrate how to create a new FURLS 

user account if your establishment did 

not create an account in FY 2008. 

Enter your existing account ID and 

password to log into FURLS. From the 

FURLS/FDA Industry Systems menu, 

there will be a button that you will click 

to go to the Device Registration and 

Listing Module (DRLM) of FURLS. New 

establishments will need to register and 

existing establishments will update 

their annual registration using choices 

on the DRLM menu. Once you choose 

to register or update your annual 

registration the system will prompt you 

through the entry of information about 

your establishment and your devices. If 

you have any problems with this 

process, e-mail reglist@cdrh.fda.gov or 

call 240–276–0111 for assistance. 

(Note: This e-mail address and phone 

number are for assistance with 

establishment registration only, and not 

for any other aspects of medical device 

user fees.) 

D. Step Four—Enter Your DFUF Order 

PIN and PCN 

After completing your annual or 

initial registration and device listing, 

you will be prompted to enter your 

DFUF order PIN and PCN, when 

applicable. Fees are only required for 

those establishments defined in section 

I of this document. 

Dated: July 28, 2008. 

Jeffrey Shuren, 

Associate Commissioner for Policy and 

Planning. 

[FR Doc. E8–17739 Filed 7–31–08; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2008–N–0427] 

Prescription Drug User Fee Rates for 

Fiscal Year 2009 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

rates for prescription drug user fees for 

fiscal year (FY) 2009. The Federal Food, 

Drug, and Cosmetic Act (the act), as 

amended by the Prescription Drug User 

Fee Amendments of 2007 (PDUFA IV) 

(Title 1 of the Food and Drug 

Administration Amendments Act of 

2007 (FDAAA)), authorizes FDA to 

collect user fees for certain applications 

for approval of drug and biological 

products, on establishments where the 

products are made, and on such 

products. Base revenue amounts to be 

generated from PDUFA fees were 

established by PDUFA IV, with 

provisions for certain adjustments. Fee 

revenue amounts for applications, 

establishments, and products are to be 

established each year by FDA so that 

mstockstill on PROD1PC66 with NOTICES