136 Federal Register / Vol. 72, No. 1 / Wednesday, January 3, 2007 / Notices 

Dated: December 22, 2006. 

Randall W. Lutter, 

Associate Commissioner for Policy and 

Planning. 

[FR Doc. E6–22450 Filed 12–29–06; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. 2003N–0573] 

Draft Animal Cloning Risk 

Assessment; Proposed Risk 

Management Plan; Draft Guidance for 

Industry; 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 on 

animal cloning. FDA’s Center for 

Veterinary Medicine (CVM) developed 

this draft risk assessment to evaluate the 

health risks to animals involved in the 

process of cloning and to evaluate the 

food consumption risks that may result 

from edible products derived from 

animal clones or their progeny. FDA is 

also announcing the availability of, and 

is requesting comment on, a proposed 

risk management plan for animal clones 

and their progeny. The proposed risk 

management plan takes into account the 

risks identified in the draft risk 

assessment and sets out proposed 

measures that FDA might use to manage 

those risks. In addition, FDA is 

announcing availability of draft 

guidance for industry #179 for public 

comment. This draft guidance describes 

FDA’s recommendations regarding the 

use of edible products from animal 

clones and their progeny in human food 

or in animal feed. 

DATES: Submit written or electronic 

comments on the draft risk assessment 

document, the proposed risk 

management plan, and the draft 

guidance for industry by April 3, 2007. 

FDA will accept comments, data, and 

information after the deadline, but to 

ensure consideration by the agency in 

any final documents, comments must be 

received by this date. Comments on 

agency guidance documents are 

welcome at any time. 

ADDRESSES: Submit written requests for 

single copies of the draft risk 

assessment, proposed risk management 

plan, or the draft guidance for industry 

to the Communications Staff (HFV–12), 

Center for Veterinary Medicine, Food 

and Drug Administration, 7519 Standish 

Pl., Rockville, MD 20855. Send a selfaddressed, adhesive label to assist that 

office in processing your request. 

Submit written comments on the draft 

risk assessment, proposed risk 

management plan, or draft guidance for 

industry 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. See 

the SUPPLEMENTARY INFORMATION section 

for electronic access to the documents. 

FOR FURTHER INFORMATION CONTACT: 

Larisa Rudenko, Center for Veterinary 

Medicine (HFV–100), Food and Drug 

Administration, 7500 Standish Pl., 

Rockville, MD 20855, 240–453–6842, email: clones@cvm.fda.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

In July 2001, FDA’s CVM issued an 

update on livestock cloning (available at 

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

clones.htm) and indicated its intention 

to work with stakeholders to assess 

potential risks presented by cloning 

food-producing animals. It also 

requested that companies voluntarily 

refrain from introducing animal clones, 

their progeny, or their food products 

(such as milk or meat) into the human 

or animal food supply, pending 

completion of the risk assessment 

process. The public participation phase 

of this process begins with the release 

of draft documents entitled ‘‘Animal 

Cloning: A Draft Risk Assessment,’’

‘‘Animal Cloning: Proposed Risk 

Management Plan for Clones and Their 

Progeny,’’ and ‘‘Draft Guidance for 

Industry #179: Use of Edible Products 

From Animal Clones or Their Progeny 

for Human Food or Animal Feed.’’

Among the goals of our draft risk 

assessment were the determination of 

whether somatic cell nuclear transfer 

(SCNT), the process used to produce the 

clones being considered in the risk 

assessment, poses any unique risks to 

animals involved in cloning relative to 

other assisted reproductive 

technologies, and whether foods derived 

from animal clones or their progeny 

pose consumption risks greater than 

those posed by foods derived from their 

conventional counterparts. It 

specifically does not consider risk 

issues that may be posed by genetically 

engineered animals. 

The draft risk assessment has been 

peer reviewed in accordance with the 

Office of Management and Budget’s 

Information Quality Peer Review 

Bulletin. The peer reviewers’ comments 

and the agency’s response to them are 

posted on the Internet with the draft risk 

assessment (see the Electronic Access 

section of this document). 

The proposed risk management plan 

describes proposed measures that the 

agency might use to address animal 

health and food consumption risks 

identified in the draft risk assessment 

that are within the agency’s purview. It 

also describes the agency’s plans with 

regard to issues that are not within the 

agency’s authority to manage (e.g., 

ethics) regarding animal cloning. 

The draft guidance for industry 

describes FDA’s recommendations 

regarding the introduction of edible 

products from animal clones and their 

progeny into the food and feed supply. 

FDA will consider information received 

during the comment period in its 

preparation of a final risk assessment. 

To that end, FDA requests that any 

producers or breeders of clones who 

have additional data on the health of the 

clones or their progeny or composition 

of food products (i.e., meat or milk) 

derived from clones or their progeny 

share those data with us. Additionally, 

the agency reiterates that the release of 

these draft documents does not affect its 

request to industry to continue to refrain 

from introducing food products from 

clones and their progeny into the 

marketplace. 

II. Significance of Guidance 

The draft guidance for industry is a 

level 1 draft guidance that is being 

issued consistent with FDA’s good 

guidance practices regulation (21 CFR 

10.115). The draft guidance represents 

the agency’s current thinking on the 

topic. The draft guidance document 

does not create or confer any rights for 

or on any person and will not operate 

to bind FDA or the public. Alternative 

methods may be used as long as they 

satisfy the requirements of the 

applicable statutes and regulations. 

III. Comments 

Interested persons may submit to the 

Division of Dockets Management (see 

ADDRESSES) written or electronic 

comments regarding the draft risk 

assessment document, the proposed risk 

management plan, and the draft 

guidance for industry. For convenience 

in reviewing the comments, FDA 

requests that comments be separately 

identified as to which document they 

address. 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 


rwilkins on PROD1PC63 with NOTICES
Federal Register / Vol. 72, No. 1 / Wednesday, January 3, 2007 / Notices 137 

document. 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 

Persons with access to the Internet 

may obtain the documents at http:// 

www.fda.gov/cvm/cloning.htm. In an 

effort to better ensure broad awareness 

of this Federal Register notice, FDA will 

announce it and make copies available 

through the FDA Dockets Listserv 

(http://www.fda.gov/ohrms/dockets/ 

FDAMAIL/DMBemaillist.htm). To be 

added to any of FDA’s free e-mail 

subscription services go to http:// 

www.fda.gov. Click on ‘‘Subscribe to 

FDA’s E-mail Lists,’’ then follow the 

instructions provided. 

Dated: August 18, 2006. 

Jeffrey Shuren, 

Assistant Commissioner for Policy. 

[FR Doc. 06–9927 Filed 12–28–06; 11:00 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. 2006D–0504] 

Draft Guidance for Industry and Food 

and Drug Administration Staff; RadioFrequency Wireless Technology in 

Medical Devices; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of the draft guidance 

entitled ‘‘Draft Guidance for Industry 

and FDA Staff; Radio-Frequency 

Wireless Technology in Medical 

Devices.’’ This draft guidance document 

addresses issues relevant to the safe and 

effective use of radio frequency (RF) 

wireless technology in medical devices, 

including wireless coexistence, 

performance, data integrity, security, 

and electromagnetic compatibility 

(EMC). These issues involve all stages of 

the product life cycle and should be 

considered in preparing premarket 

submissions; identifying, documenting, 

and implementing product design 

requirements, as well as design 

verification and validation; and risk 

management processes and procedures. 

DATES: Submit written or electronic 

comments on the draft guidance by 

April 2, 2007. 

ADDRESSES: Submit written requests for 

single copies of the draft guidance 

entitled ‘‘Draft Guidance for Industry 

and FDA Staff: Radio-Frequency 

Wireless Technology in Medical 

Devices’’ 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 240–276–

3151. 

Submit written comments on the draft 

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. See 

the SUPPLEMENTARY INFORMATION section 

for information on electronic access to 

the guidance. 

FOR FURTHER INFORMATION CONTACT: 

Donald Witters, Center for Devices and 

Radiological Health (HFZ–130), Food 

and Drug Administration, 12725 

Twinbrook Pkwy., Rockville, MD 20852, 

301–827–4955. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA has developed this draft 

guidance document to assist industry, 

systems and service providers, 

consultants, FDA staff, and others in the 

design, development, and evaluation of 

RF wireless technology in medical 

devices. The RF wireless emissions from 

one product or device can affect the 

function of another, the electromagnetic 

environments where medical devices 

are used may contain many sources of 

RF energy, and the use of RF wireless 

technology in and around medical 

devices is increasing. As a result, the 

draft guidance recommends that 

manufacturers address concerns about 

the potential effects of the use of RF 

wireless technology in and around 

medical devices on the ability of 

medical devices to function properly 

and the resultant safety of patients and 

operators. 

This draft guidance references 

national and international standards 

and discusses some of FDA’s regulatory 

requirements, including premarket 

requirements (21 CFR parts 807 and 

814). The draft guidance document also 

discusses quality system requirements 

as they specifically apply to RF wireless 

technology in medical devices, 

including design and development 

activities (21 CFR part 820). 

II. Significance of Guidance 

This draft guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The draft guidance, when finalized, will 

represent the agency’s current thinking 

on RF wireless technology in and 

around medical devices. 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 

Persons interested in obtaining a copy 

of the draft guidance may do so by using 

the Internet. To receive ‘‘Draft Guidance 

for Industry and FDA Staff; RadioFrequency Wireless Technology in 

Medical Devices’’ you may either send 

an e-mail request to dsmica@fda.hhs.gov 

to receive an electronic copy of the 

document or send a fax request to 240–

276–3151 to receive a hard copy. Please 

use the document number 1618 to 

identify the guidance you are 

requesting. 

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 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 draft guidance refers to 

previously approved collections of 

information found in FDA regulations. 

These collections of information are 

subject to review by the Office of 

Management and Budget (OMB) under 

the Paperwork Reduction Act of 1995 

(44 U.S.C. 3501–3520). The collections 

of information in 21 CFR part 801 have 

been approved under OMB control 

number 0910–0485; the collections of 

information in 21 CFR part 807 have 

been approved under OMB control 

number 0910–0120; the collections of 

information in 21 CFR part 814 have 

been approved under OMB control 

number 0910–0231; and the collections 


rwilkins on PROD1PC63 with NOTICES