RE: Docket No. 02N–0466/Reminder

[Guest guest]

Just a reminder to enter your comments to the FDA (made easy). I have

searched and we are VERY poor in taking care of our future " THE CHILDREN " .

Presently there are 130 names for EC; and ONLY 36 EMC (email correspondance).

Please respond today! If you don't think this doesn't concern you, think

twice! Clinical studies on smallpox in children 2-5 years of age.

 

 

Jane

 

 

Here is where you can search for your name:

 

http://63.75.126.224/Google/fda_search.pl?q=Docket+No.+02N%960466 & client=fdago

 

v & site=fdagov & searchselector= & restrict= & sa=Search

 

 

Corresponding to the FDA made easy! Cut and copy.

 

*When corresponding to the FDA about your written comments on use of the

smallpox vaccine trial on 2-5 year old children, please use the address below

and it is important to insert in the subject the docket number:

 

Address: fdadockets

RE: Docket No. 02N–0466

 

Your comment can simply say " I DO NOT support the smallpox vaccine study,

Docket No. 02N–0466. "

 

Also remember the FDA WORKS for US!

 

DATES: To be considered, written or electronic comments on the proposed

research must be received on or before 4:30 p.m. December 2, 2002.

ADDRESSES: Submit written comments to the Dockets Management Branch

(HFA–305), Docket Number 02N–0466, Food and Drug Administration, 5630 Fishers

Lane, Room 1061, Rockville, MD 20852. Submit electronic comments to

http://www.fda.gov/dockets/ecomments. All comments should be identified with

the docket number found in brackets in the heading of this document. Received

comments may be viewed on the FDA Web site at: http://www.fda.gov/ohrms/

dockets/dockets/02n0466/02n0466.htm or may be seen in the Dockets Management

Branch between 9 a.m. and 4 p.m., Monday through Friday.

 

~ ~ ~ ~ DETAILS ~ ~ ~ ~ ~ ~

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Office of Public Health and Science

and Food and Drug Administration

[Docket No. 02N–0466]

Solicitation of Public Review and

Comment on Research Protocol: A

Multicenter, Randomized Dose

Response Study of the Safety, Clinical

and Immune Response of Dryvax

Administered to Children 2 to 5 Years

of Age

AGENCY: Office of Public Health and

Science and Food and Drug

Administration, HHS.

ACTION: Notice.

SUMMARY: The Office for Human

Research Protections (OHRP), Office of

Public Health and Science, Department

of Health and Human Services (HHS)

and the Food and Drug Administration

(FDA), HHS are soliciting public review

and comment on a proposed research

protocol entitled ‘‘A Multicenter,

Randomized Dose Response Study of

the Safety, Clinical and Immune

Response of DryvaxAdministered to

Children 2 to 5 Years of Age.’’ The

proposed research would be supported

by a contract awarded by the National

Institutes of Health (NIH) and

conducted under an Investigational New

Drug Application (IND) filed with the

FDA. Public review and comment is

solicited regarding the proposed

research protocol pursuant to the

requirements of HHS regulations at 45

CFR 46.407 and FDA regulations at 21

CFR 50.54.

DATES: To be considered, written or

electronic comments on the proposed

research must be received on or before

4:30 p.m. December 2, 2002.

ADDRESSES: Submit written comments

to the Dockets Management Branch

(HFA–305), Docket Number 02N–0466,

Food and Drug Administration, 5630

Fishers Lane, Room 1061, Rockville, MD

20852. Submit electronic comments to

http://www.fda.gov/dockets/ecomments.

All comments should be identified with

the docket number found in brackets in

the heading of this document. Received

comments may be viewed on the FDA

Web site at: http://www.fda.gov/ohrms/

dockets/dockets/02n0466/02n0466.htm

or may be seen in the Dockets

Management Branch between 9 a.m. and

4 p.m., Monday through Friday.

FOR FURTHER INFORMATION CONTACT: Dr.

Leslie K. Ball, Office for Human

Research Protection, The Tower

Building, 1101 Wootton Parkway, Suite

200, Rockville, MD 20852; telephone301–496–7005; fax 301–402–0527; e-mail:

LBall; or Ms.

Patricia M. Beers Block, Office for Good

Clinical Practice, OSHC, Office of the

Commissioner, Food and Drug

Administration, 5600 Fishers Lane, HF–

34, Rockville, MD 20857; telephone

301–827–3340; fax 301–827–1169; e-mail:

pbeersblock.

SUPPLEMENTARY INFORMATION: All

studies conducted or supported by HHS

which are not otherwise exempt and

which propose to involve children as

subjects require Institutional Review

Board (IRB) review in accordance with

the provisions of HHS regulations at 45

CFR part 46, subpart D. Under FDA’s

Interim Final Rule effective April 30,

2001 (21 CFR part 50, subpart D), FDA

adopted similar regulations to provide

safeguards for children enrolled in

clinical investigations of FDA-regulated

products.

Pursuant to HHS regulations at 45

CFR 46.407 and FDA regulations at 21

CFR 50.54, if an IRB reviewing a

protocol conducted or supported by

HHS for a clinical investigation

regulated by FDA does not believe that

the proposed research or clinical

investigation involving children as

subjects meets the requirements of HHS

regulations at 45 CFR 46.404, 46.405, or

46.406, and FDA regulations at 21 CFR

50.51, 50.52, or 50.53, respectively, the

research or clinical investigation may

proceed only if the following conditions

are met: (a) The IRB finds and

documents that the research or clinical

investigation presents a reasonable

opportunity to further the

understanding, prevention, or

alleviation of a serious problem

affecting the health and welfare of

children; and (b) the Secretary (HHS)

and the Commissioner (FDA),

respectively, after consultation with a

panel of experts in pertinent disciplines

(for example: science, medicine,

education, ethics, law) and following

opportunity for public review and

comment determine either:

(1) That the research or the clinical

investigation in fact satisfies the

conditions of 45 CFR 46.404, 46.405, or

46.406 under HHS regulations, and 21

CFR 50.51, 50.52, or 50.53 under FDA

regulations, or (2) that the following

conditions are met: (i) The research or

clinical investigation presents a

reasonable opportunity to further the

understanding, prevention, or

alleviation of a serious problem

affecting the health or welfare of

children; (ii) the research or clinical

investigation will be conducted in

accordance with sound ethical

principles; and (iii) adequate provisions

are made for soliciting the assent of

children and the permission of their

parents or guardians, as set forth in 45

CFR 46.408 and 21 CFR 50.55.

HHS received a request from Harbor-UCLA

Medical Center to review a

protocol entitled ‘‘A Multicenter,

Randomized Dose Response Study of

the Safety, Clinical and Immune

Response of DryvaxAdministered to

Children 2 to 5 Years of Age’’ pursuant

to the provisions of HHS regulations at

45 CFR 46.407. The sponsor of this

research, the National Institute of

Allergy and Infectious Diseases (NIAID),

NIH, proposes to study the safety and

immune response to Dryvax(vaccinia

virus vaccine), when administered to

children 2 to 5 years of age. This study

proposes to evaluate Dryvaxat its full,

licensed strength and at a 1:5 dilution,

in children enrolled in a number of

sites, including Harbor-UCLA Medical

Center and Cincinnati Children’s

Hospital Medical Center. Use of

Dryvaxin this protocol is being

performed under an FDA IND primarily

because there are no data to support the

efficacy of the 1:5 dilution of this

product in children. This protocol was

developed by NIAID in the context of

current HHS bioterrorism preparedness

plans, given the potential risk of

smallpox being used as a weapon of

bioterrorism, and has been approved by

two IRBs.

However, after reviewing this research

proposal, the Harbor-UCLA Medical

Center IRB determined that this study

could not be approved under 45 CFR

46.404, 46.405, or 46.406 but was

suitable for review under 45 CFR

46.407. Because this clinical

investigation is regulated by FDA,

FDA’s regulations at 21 CFR part 50,

subpart D, apply as well. The Harbor-UCLA

Medical Center IRB was unable to

assess the prospect of direct benefit to

the participants but found that the

research presented a reasonable

opportunity to further the

understanding, prevention or alleviation

of a serious problem affecting the health

or welfare of children. NIAID has not

initiated this clinical trial pending the

Secretary’s and Commissioner’s

determination. Experts in relevant

disciplines have reviewed this protocol

(see discussion below regarding access

to each expert’s report), but prior to the

Secretary and Commissioner making a

final determination, public review and

comment are hereby solicited pursuant

to HHS regulations at 45 CFR 46.407

and FDA regulations at 21 CFR 50.54. In

particular, comments are solicited on

the following questions: (1) What are the

potential benefits of the research, if any,

to the subjects and to children in

general; (2) what are the types and

degrees of risk that this research

presents to the subjects; (3) are the risks

to the subjects reasonable in relation to

the anticipated benefits, if any, to the

subjects, and the importance of the

knowledge that may reasonably be

expected to result; and (4) does the

research present a reasonable

opportunity to further the

understanding, prevention, or

alleviation of a serious problem

affecting the health or welfare of

children?

All written comments concerning this

matter should be submitted to FDA’s

Dockets Management Branch pursuant

to 21 CFR 10.20. Received comments

may be viewed on the FDA Web site at:

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

dockets/02n0466/02n0466.htm or may

be seen in the Dockets Management

Branch between the 9 a.m. and 4 p.m.,

Monday through Friday.

Materials available for review on the

OHRP Web page (available at http://

ohrp.osophs.dhhs.gov/dpanel/

dpindex.htm) include: The NIH

protocol, site-specific protocol

application reviewed by the Harbor-UCLA

Medical Center IRB, sample

parental permission document, relevant

package inserts, and reports of each of

the experts pursuant to HHS regulations

at 45 CFR 46.407 and FDA regulations

at 21 CFR 50.54. A paper copy of the

information referenced here is available

upon request.

Dated: October 23, 2002.

Lester M. Crawford,

Deputy Commissioner, FDA.

Dated: October 24, 2002.

Eve E. Slater,

Assistant Secretary for Health.

[FR Doc. 02–27769 Filed 10–30–02; 8:45 am]

BILLING CODE 4150–28–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 02N–0454]

Agency Information Collection

Activities; Proposed Collection;

Comment Request; Notice of a Claim

for Generally Recognized as Safe

Exemption Based on a Generally

Recognized as Safe Determination

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing an

opportunity for public comment on the

 

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