25750 Federal Register / Vol. 73, No. 89 / Wednesday, May 7, 2008 / Notices 

Modernization Act of 1997, provides 

that any person may market a food 

product whose label bears a nutrient 

content claim or a health claim that is 

based on an authoritative statement of a 

scientific body of the U.S. Government 

or the National Academy of Sciences 

(NAS). Under this section of the act, a 

person that intends to use such a claim 

must submit a notification of its 

intention to use the claim 120 days 

before it begins marketing the product 

bearing the claim. In the Federal 

Register of June 11, 1998 (63 FR 32102), 

FDA announced the availability of a 

guidance entitled ‘‘Guidance for 

Industry: Notification of a Health Claim 

or Nutrient Content Claim Based on an 

Authoritative Statement of a Scientific 

Body.’’ The guidance provides the 

agency’s interpretation of terms central 

to the submission of a notification and 

the agency’s views on the information 

that should be included in the 

notification. The agency believes that 

the guidance will enable persons to 

meet the criteria for notifications that 

are established in section 403(r)(2)(G) 

and (r)(3)(C) of the act. In addition to the 

information specifically required by the 

act to be in such notifications, the 

guidance states that the notifications 

should also contain information on 

analytical methodology for the nutrient 

that is the subject of a claim based on 

an authoritative statement. FDA intends 

to review the notifications the agency 

receives to ensure that they comply with 

the criteria established by the act. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1.— ESTIMATED ANNUAL REPORTING BURDEN1

Section of the Act/Basis of Burden No. of 

Respondents 

Annual 

Frequency per 

Response 

Total Annual 

Responses 

Hours Per 

Response Total Hours 

403(r)(2)(G) (nutrient content claims) 1 1 1 250 250 

403(r)(2)(C) (health claims) 2 1 2 450 900 

Guidance for notifications 3 1 3 1 3 

Total 1,153 

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

These estimates are based on FDA’s 

experience with health claims, nutrient 

content claims, and other similar 

notification procedures that fall under 

the agency’s jurisdiction. FDA estimates 

that it will receive one nutrient content 

claim notification and two health claim 

notifications per year. 

Section 403(r)(2)(G) and 403(r)(3)(C) 

of the act requires that the notification 

include the exact words of the claim, a 

copy of the authoritative statement, a 

concise description of the basis upon 

which such person relied for 

determining that this is an authoritative 

statement as outlined in the act, and a 

balanced representation of the scientific 

literature relating to the relationship 

between a nutrient and a disease or 

health-related condition to which a 

health claim refers or to the nutrient 

level to which the nutrient content 

claim refers. This balanced 

representation of the scientific literature 

is expected to include a bibliography of 

the scientific literature on the topic of 

the claim and a brief, balanced account 

or analysis of how this literature either 

supports or fails to support the 

authoritative statement. 

Since the claims are based on 

authoritative statements of a scientific 

body of the Federal government or NAS, 

FDA believes that the information that 

is required by the act to be submitted 

with a notification will be readily 

available to a respondent. However, the 

respondent will have to collect and 

assemble that information. Based on 

communications with firms that have 

submitted notifications, FDA estimates 

that it will take a respondent 250 hours 

to collect and assemble the information 

required by the statute for nutrient 

content claim notifications and 450 

hours to collect and assemble the 

information required by the statute for 

health claim notifications. 

Under the guidance, notifications 

should also contain information on 

analytical methodology for the nutrient 

that is the subject of a claim based on 

an authoritative statement. The 

guidance applies to both nutrient 

content claim and health claim 

notifications. FDA has determined that 

this information should be readily 

available to a respondent and, thus, the 

agency estimates that it will take a 

respondent 1 hour to incorporate the 

information into the notification. 

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 only through FDMS at 

http://www.regulations.gov. 

Dated: May 1, 2008. 

Jeffrey Shuren, 

Associate Commissioner for Policy and 

Planning. 

[FR Doc. E8–10180 Filed 5–6–08; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2008–N–0269] 

Agency Emergency Processing Under 

Office of Management and Budget 

Review; Implementation of Sections 

222, 223, and 224 of the Food and Drug 

Administration Amendments Act of 

2007 

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 emergency processing under 

the Paperwork Reduction Act of 1995 

(the PRA). The proposed collection of 

information concerns the requirement 

established by the Food and Drug 

Administration Amendments Act of 

2007 (FDAAA), that device 

establishments must submit registration 

and listing information by electronic 

means using FDA Form 3673, unless the 

Secretary of Health and Human Services 

(the Secretary) grants them a waiver 

from the electronic submission 

requirement. 

DATES: Fax written comments on the 

collection of information by June 6, 

2008. 


sroberts on PROD1PC70 with NOTICES
Federal Register / Vol. 73, No. 89 / Wednesday, May 7, 2008 / Notices 25751 

ADDRESSES: To ensure that comments on 

the information collection are received, 

OMB recommends that written 

comments be faxed to the Office of 

Information and Regulatory Affairs, 

OMB, Attn: FDA Desk Officer, FAX: 

202–395–6974, or e-mailed to 

baguilar@omb.eop.gov. All comments 

should be identified with the OMB 

control number 0910–NEW and title 

‘‘Implementation of Sections 222, 223, 

and 224 of the Food and Drug 

Administration Amendments Act of 

2007; (21 U.S.C. 360); Emergency 

Request.’’ Also include the FDA docket 

number found in brackets in the 

heading of this document. 

FOR FURTHER INFORMATION CONTACT: 

Denver Presley, Jr., Office of the Chief 

Information Officer (HFA–250), Food 

and Drug Administration, 5600 Fishers 

Lane, Rockville, MD 20857, 301–827–

1472. 

SUPPLEMENTARY INFORMATION: FDA is 

requesting emergency processing of this 

proposed collection of information 

under section 3507(j) of the PRA (44 

U.S.C. 3507(j) and 5 CFR 1320.13)). Title 

II of FDAAA (Public Law 110–85), 

enacted September 27, 2007, amends 

section 510 of the Federal Food, Drug, 

and Cosmetic Act (FD&C Act) (21 U.S.C. 

360) to require all domestic and foreign 

device establishments to submit 

registration and device listing 

information to FDA by electronic 

means, and specifies the timeframes 

when establishments are required to 

submit such information. These new 

registration and listing requirements 

were in effect on October 1, 2007. The 

proposed collection of information 

concerns the information that owners/ 

operators of device establishments must 

submit electronically in order to register 

their establishments and list their 

devices using FDA Form No. 3673. In 

addition, owners/operators seeking a 

waiver from the electronic submission 

requirements will need to submit a 

written request for a waiver to FDA with 

a complete explanation as to why their 

registration and listing information 

cannot be submitted electronically. See 

sections 222, 223, and 224 of FDAAA. 

Thus, FDA is requesting emergency 

processing of this new collection of 

information for electronic registration 

and listing, and information relating to 

requests for waivers. 

With respect to the following 

collection of information, FDA invites 

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. 

Implementation of Sections 222, 223, 

and 224 of the Food and Drug 

Administration Amendments Act of 

2007; (21 U.S.C. 360); Emergency 

Request 

Sections 222, 223, and 224 of FDAAA, 

which were in effect on October 1, 2007, 

require that device establishment 

registrations and listings under section 

510 of the FD&C Act (including the 

submission of updated information) be 

submitted to the Secretary by electronic 

means, unless the Secretary grants a 

request for waiver of the requirement 

because the use of electronic means is 

not reasonable for the person requesting 

the waiver. FDA expects that 20,000 to 

30,000 device establishments will need 

to register electronically between now 

and December 31, 2008. Section 224 of 

FDAAA requires that these 

establishments also must have an 

opportunity request waivers. Thus, 

emergency approval of this request is 

necessary to implement these provisions 

of the statute. 

Section 222 of FDAAA amends 

section 510(b) of the FD&C Act to 

require domestic establishments to 

register annually during the period 

beginning October 1 and ending 

December 31 of each year. Section 222 

of FDAAA also amends section 510(i)(1) 

of the FD&C Act to require foreign 

establishments to immediately register 

upon first engaging in one of the 

covered device activities described 

under the statute, and they must also 

register annually during the period 

beginning on October 1 and ending on 

December 31 of each year. In addition, 

section 223 of FDAAA amends section 

510(j)(2) of the FD&C Act to require 

establishments to list their devices 

annually with FDA during the period 

beginning on October 1 and ending on 

December 31 of each year. 

Under FDAAA, device establishment 

owners/operators are required to keep 

their registration and device listing 

information up-to-date using the 

agency’s new electronic system. 

Owners/operators of new device 

establishments must use the electronic 

system to create new accounts, new 

registration records, and new device 

listings. Section 224 of FDAAA amends 

section 510(p) of the FD&C Act by 

allowing a person affected to request a 

waiver from the requirement to register 

electronically when the ‘‘use of 

electronic means’’ is not reasonable for 

the person. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1

Section of 

the 2007 

Amendments 

FDA Form No. No. 

of Respondents 

Annual Frequency 

per Response 

Total Annual 

Responses 

Hours 

per Response Total Hours 

2222 3673 2,600 1 2,704 0.5 1,352 

2232 3673 24,382 1 24,382 0.25 6,095 

2242 29,370 1 29,370 0.75 22,028 

2243 2,600 1 2,600 0.5 1,300 

224 (waiver request)2 20 1 20 1 20 

224 (waiver request)3 1 1 1 1 1 


sroberts on PROD1PC70 with NOTICES
25752 Federal Register / Vol. 73, No. 89 / Wednesday, May 7, 2008 / Notices 

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1—Continued 

Section of 

the 2007 

Amendments 

FDA Form No. No. 

of Respondents 

Annual Frequency 

per Response 

Total Annual 

Responses 

Hours 

per Response Total Hours 

Total Hours 30,796 

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

2One time burden. 

3Annual increase in burden. 

The estimates in table 1 of this 

document are based on FDA’s 

experience, data from the device 

registration and listing database, and 

our estimates of the time needed to 

complete the previously required forms. 

We estimate that the time needed to 

enter registration and listing 

information electronically using FDA 

Form 3673 will not differ significantly 

from the time needed to fill in the paper 

forms (FDA Forms 2891, 2891a, and 

2892) that previously were used for this 

purpose because the information 

required is essentially identical. 

In addition, under section 224 of 

FDAAA, device establishments owner/ 

operators for whom registering and 

listing by electronic means is not 

reasonable may request a waiver from 

the Secretary. Because a device 

establishment’s owner/operator required 

to register and list would only need to 

have access to a computer, Internet, and 

an e-mail address for registration and 

list by electronic means, the agency did 

not anticipate the receipt of a large 

number of requests for waiver. For the 

first few months of operation of the 

web-based system, i.e., October through 

December 2007, FDA received fewer 

than 10 requests for waivers from the 

requirement to submit registration and 

listing information electronically. As 

data for more than 16,000 

establishments have been received 

electronically for the same period, these 

requests amount to less than 1 percent 

of the total number of establishments 

that have responded. 

Based on information taken from our 

databases, FDA estimates that there are 

29,370 owner/operators who 

collectively register a total of 33,490 

device establishments. The number of 

respondents listed for section 224 of 

FDAAA in the burden table is 29,370, 

which corresponds to the number of 

owner/operators who annually register 

one or more establishments. In addition, 

FDA estimates that 4,988 owner/ 

operators are initial importers who must 

register their establishments but who, 

under FDA’s existing regulations, are 

not required to list their devices unless 

they initiate or develop the 

specifications for the devices or 

repackage or relabel the devices. The 

number of respondents included in the 

burden table for section 223 of FDAAA 

is 24,382, which corresponds to the 

number of owner/operators who list one 

or more devices annually (29,370 - 4,988 

= 24,382). 

To calculate the burden estimate for 

waiver requests under section 224 of 

FDAAA, we assume as stated previously 

that less than one tenth of one percent 

of the 33,490 total device establishments 

would request waivers from FDA. This 

means the total number of waiver 

requests would probably not exceed 20 

requests (33,490 x 0.0006). We also 

estimate that the one-time burden on 

these establishments would be an hour 

of time for a mid-level manager to draft, 

approve, and mail a letter. In addition, 

FDA estimates the total number of 

establishments will increase by 2,600 

new establishments each year. Of the 

2,600 new registrants each year, we 

assume that less than one percent (i.e., 

1) of these will also request waivers 

each year. The total, therefore, is 21 

waiver requests, which could increase 

by only 1 additional request each year. 

Dated: May 1, 2008. 

Jeffrey Shuren, 

Associate Commissioner for Policy and 

Planning. 

[FR Doc. E8–10194 Filed 5–6–08; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2008–D–0228] (formerly 

Docket No. 00D–1401) 

Guidance for Industry and Food and 

Drug Administration Staff; 

Administrative Procedures for CLIA 

Categorization; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of the guidance entitled 

‘‘Administrative Procedures for CLIA 

Categorization.’’ The guidance describes 

FDA’s current practices concerning the 

administrative aspects of categorizing 

commercially available in vitro 

diagnostic tests under the Clinical 

Laboratory Improvement Amendments 

of 1988 (CLIA). The guidance discusses 

what manufacturers should submit to 

help expedite CLIA categorization by 

FDA. 

DATES: Submit written or electronic 

comments on this guidance at any time. 

General comments on agency guidance 

documents are welcome at any time. 

ADDRESSES: Submit written requests for 

single copies of the guidance document 

entitled ‘‘Administrative Procedures for 

CLIA Categorization’’ to the Division of 

Small Manufacturers, International, and 

Consumer Assistance (HFZ–220), Center 

for Devices and Radiological Health, 

Food and Drug Administration, 1350 

Piccard Dr., Rockville, MD 20850. Send 

one self-addressed adhesive label to 

assist the office in processing your 

request, or fax your request to 240–276–

3151. See the SUPPLEMENTARY

INFORMATION section for information on 

electronic access to the guidance. 

Submit written comments concerning 

this guidance 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. Identify 

comments with the docket number 

found in brackets in the heading of this 

document. 

FOR FURTHER INFORMATION CONTACT: 

Carol Benson, Center for Devices and 

Radiological Health (HFZ–440), Food 

and Drug Administration, 2098 Gaither 

Rd., Rockville, MD 20850, 240–276–

0491, ext. 117. 

SUPPLEMENTARY INFORMATION: 

I. Background 

On February 28, 1992, the Department 

of Health and Human Services 

published the final laboratory standards 

regulations (57 FR 7002) implementing 

CLIA (42 U.S.C. 263a). The 

implementing regulations are codified at 

42 CFR part 493. CLIA regulates 

laboratory testing and requires that 

clinical laboratories obtain a certificate 


sroberts on PROD1PC70 with NOTICES