Federal Register / Vol. 69, No. 226 / Wednesday, November 24, 2004 / Notices 68383

conditions that those developers have 

no concerns that the new protein could 

enter the food supply.

FDA scientists predict that this draft 

guidance will generate about 20 to 150 

early food safety evaluations yearly. 

While there is uncertainty as to the 

number of developers who will choose 

to submit an evaluation, FDA estimates 

that the annual number of early food 

safety evaluations will be closer to the 

lower bound estimate of 20 evaluations 

rather than the upper bound estimate of 

150 evaluations. This estimation is 

supported by the fact that on average 

there have been nine initial 

biotechnology consultations per year; an 

initial biotechnology consultation has 

traditionally been the first discussion 

between a developer and FDA about a 

bioengineered food.

Evaluation Components

The early food safety evaluation for 

new proteins includes six main data 

components. Four of these data 

components are easily and quickly 

obtainable, having to do with the 

identity and source of the protein. FDA 

estimates that completing these data 

components will take about 4 hours per 

evaluation. In table 1 of this document, 

row 1 shows that for 20 evaluations, the 

total burden for these 4 data 

components is 80 hours.

Two data components ask for original 

data to be generated. One data 

component consists of a bioinformatics 

analysis which can be performed using 

publicly available databases. The other 

data component involves ‘wet’ lab work 

to assess the new protein’s stability and 

the resistance of the protein to 

enzymatic degradation using 

appropriate in vitro assays (protein 

digestibility study).

The paperwork burden of these two 

data components consists of the time it 

takes the company to put together the 

information on these two data 

components to submit to FDA. We 

estimate that these two data components 

will take 16 hours to complete (8 hours 

for each component). Table 1, row 2, 

shows that for 20 evaluations, the total 

burden for these two data components 

is 320 hours.

III. Comments

Interested persons may submit to the 

Division of Dockets Management (see 

ADDRESSES) written or electronic 

comments regarding the draft guidance 

and the collection of information 

provisions. 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. The draft guidance and 

received comments may be seen in the 

Division of Dockets Management 

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

through Friday.

IV. Electronic Access

An electronic version of the draft 

guidance is available on the Internet at 

http://www.cfsan.fda.gov/guidance.html

and http://www.fda.gov/cvm.

Dated: November 17, 2004.

Jeffrey Shuren,

Assistant Commissioner for Policy.

[FR Doc. 04–26049 Filed 11–19–04; 1:52 pm]

BILLING CODE 4160–01–S

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES

Food and Drug Administration

[Docket No. 2004D–0481]

Guidance for Industry and Food and 

Drug Administration Staff; Class II 

Special Controls Guidance Document: 

Newborn Screening Test Systems for 

Amino Acids, Free Carnitine, and 

Acylcarnitines Using Tandem Mass 

Spectrometry; Availability

AGENCY: Food and Drug Administration, 

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of the guidance entitled 

‘‘Class II Special Controls Guidance 

Document: Newborn Screening Test 

Systems for Amino Acids, Free 

Carnitine, and Acylcarnitines Using 

Tandem Mass Spectrometry.’’ This 

guidance document describes a means 

by which newborn screening test 

systems for amino acids, free carnitine, 

and acylcarnitines using tandem mass 

spectrometry may comply with the 

requirements of special controls for 

class II devices. It includes 

recommendations for validation of 

performance characteristics and 

recommendations for product labeling.

Elsewhere in this issue of the Federal 

Register, FDA is publishing a final rule 

to classify newborn screening test 

systems for amino acids, free carnitine, 

and acylcarnitines using tandem mass 

spectrometry into class II (special 

controls). This guidance document is 

immediately in effect as the special 

control for newborn screening test 

systems for amino acids, free carnitine, 

and acylcarnitines using tandem mass 

spectrometry, but it remains subject to 

comment in accordance with the 

agency’s good guidance practices 

(GGPs).

DATES: Submit written or electronic 

comments on this guidance at any time. 

General comments on agency guidances 

are welcome at any time.

ADDRESSES: Submit written requests for 

single copies on a 3.5′′ diskette of the 

guidance document entitled ‘‘Class II 

Special Controls Guidance Document: 

Newborn Screening Test Systems for 

Amino Acids, Free Carnitine, and 

Acylcarnitines Using Tandem Mass 

Spectrometry’’ 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 that office in processing your 

request, or fax your request to 301–443–

8818. 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.fda.gov/dockets/ecomments. 

Identify comments with the docket 

number found in brackets in the 

heading of this document.

FOR FURTHER INFORMATION CONTACT:

Carol C. Benson, Center for Devices and 

Radiological Health (HFZ–440), Food 

and Drug Administration, 2098 Gaither 

Rd., Rockville, MD 20850, 301–594–

1243, ext. 144.

SUPPLEMENTARY INFORMATION:

I. Background

Elsewhere in this issue of the Federal 

Register, FDA is publishing a final rule 

classifying newborn screening test 

systems for amino acids, free carnitine, 

and acylcarnitines using tandem mass 

spectrometry into class II (special 

controls) under section 513(f)(2) of the 

Federal Food, Drug, and Cosmetic Act 

(the act) (21 U.S.C. 360c(f)(2)). This 

guidance document will serve as the 

special control for newborn screening 

test systems for amino acids, free 

carnitine, and acylcarnitines that utilize 

tandem mass spectrometry. Section 

513(f)(2) of the act provides that any 

person who submits a premarket 

notification under section 510(k) of the 

act (21 U.S.C. 360(k)) for a device that 

has not previously been classified may, 

within 30 days after receiving written 

notice classifying the device in class III 

under section 513(f)(1) of the act, 

request FDA to classify the device under 

the criteria set forth in section 513(a)(1)

68384 Federal Register / Vol. 69, No. 226 / Wednesday, November 24, 2004 / Notices 

of the act. FDA shall, within 60 days of 

receiving such a request, classify the 

device by written order. This 

classification shall be the initial 

classification of the device.

Within 30 days after the issuance of 

an order classifying the device, FDA 

must publish a notice in the Federal 

Register announcing such classification. 

Because of the timeframes established 

by section 513(f)(2) of the act, FDA has 

determined, under § 10.115(g)(2) (21 

CFR 10.115(g)(2)), that it is not feasible 

to allow for public participation before 

issuing this guidance as a final guidance 

document. Therefore, FDA is issuing 

this guidance document as a level 1 

guidance document that is immediately 

in effect. FDA will consider any 

comments that are received in response 

to this notice to determine whether to 

amend the guidance document.

II. Significance of Guidance

This guidance is being issued 

consistent with FDA’s GGPs regulation 

(§ 10.115). The guidance represents the 

agency’s current thinking on newborn 

screening test systems for amino acids, 

free carnitine, and acylcarnitines that 

utilize tandem mass spectrometry. It 

does not create or confer any rights for 

or on any person and does not operate 

to bind FDA or the public. An 

alternative approach may be used if 

such approach satisfies the 

requirements of the applicable statute 

and regulations.

III. Electronic Access

To receive ‘‘Class II Special Controls 

Guidance Document: Newborn 

Screening Test Systems for Amino 

Acids, Free Carnitine, and 

Acylcarnitines Using Tandem Mass 

Spectrometry’’ by fax machine, call the 

Center for Devices and Radiological 

Health (CDRH) Facts-On-Demand 

system at 800–899–0381 or 301–827–

0111 from a touch-tone telephone. Press 

1 to enter the system. At the second 

voice prompt, press 1 to order a 

document. Enter the document number 

(1301) followed by the pound sign (#). 

Follow the remaining voice prompts to 

complete your request.

Persons interested in obtaining a copy 

of the guidance may also do so by using 

the Internet. CDRH maintains an entry 

on the Internet for easy access to 

information, including text, graphics, 

and files that may be downloaded to a 

personal computer with Internet access. 

Updated on a regular basis, the CDRH 

home page includes device safety alerts, 

Federal Register reprints, information 

on premarket submissions (including 

lists of cleared submissions, approved 

applications, and manufacturers’

addresses), small manufacturer’s 

assistance, information on video 

conferencing and electronic 

submissions, Mammography Matters, 

and other device-oriented information. 

The CDRH Web site may be accessed at 

http://www.fda.gov/cdrh. A search 

capability for all CDRH guidance 

documents is available at http://

www.fda.gov/cdrh/guidance.html. 

Guidance documents are also available 

on the Division of Dockets Management 

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

ohrms/dockets.

IV. Paperwork Reduction Act of 1995

This guidance contains information 

collection provisions that are subject to 

review by the Office of Management and 

Budget (OMB) under the Paperwork 

Reduction Act of 1995 (the PRA) (44 

U.S.C. 3501–3520). The collections of 

information addressed in the guidance 

document have been approved by OMB 

in accordance with the PRA under the 

regulations governing premarket 

notification submissions (21 CFR part 

807, subpart E, OMB control number 

0910–0120). The labeling provisions 

addressed in the guidance have been 

approved by OMB under OMB control 

number 0910–0485.

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.

Dated: November 15, 2004.

Linda S. Kahan,

Deputy Director, Center for Devices and 

Radiological Health.

[FR Doc. 04–25976 Filed 11–23–04; 8:45 am]

BILLING CODE 4160–01–S

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES

Food and Drug Administration

[Docket No. 2004N–0479]

Draft Risk Assessment of 

Streptogramin Resistance in 

Enterococcus faecium Attributable to 

the Use of Streptogramins in Animals; 

Availability

AGENCY: Food and Drug Administration, 

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of, and is requesting 

comment on, a draft risk assessment of 

the potential impact that food-animal 

use of streptogramin antimicrobials has 

on the resistance to chemically similar 

streptogramins used to treat human 

enterococcal infections. The veterinary 

drug of interest in this risk assessment 

is the streptogramin, virginiamycin, a 

drug approved for use in chicken, 

turkey, swine, and cattle feed. FDA will 

consider information received during 

the comment period in its preparation of 

a final risk assessment.

DATES: Submit written or electronic 

comments on the draft risk assessment 

document by January 24, 2005. FDA 

will accept comments, data, and 

information after the deadline, but to 

assure consideration by the agency, we 

must receive comments by this date.

ADDRESSES: Single copies of this draft 

risk assessment are available from the 

Communications Staff (HFV–12), Center 

for Veterinary Medicine, Food and Drug 

Administration, 7519 Standish Pl., 

Rockville, MD 20855. Please enclose a 

self-addressed, adhesive label to assist 

that office in processing your request. 

This draft risk assessment is also 

available on the Internet at: http://

www.fda.gov/cvm/antimicrobial/

antimicrobial.htm.

Send written comments on this draft 

risk assessment 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.accessdata.fda.gov/scripts/oc/

dockets/commentdocket.cfm.

FOR FURTHER INFORMATION CONTACT:

Barry Hooberman, Center for Veterinary 

Medicine (HFV–102), Food and Drug 

Administration, 7500 Standish Pl., 

Rockville, MD 20855, 301–827–8557, email: bhooberm@cvm.fda.gov.

SUPPLEMENTARY INFORMATION: