Loading ...
Sorry, an error occurred while loading the content.

RE: Docket No. 02N–0466

Expand Messages
  • DaRocksMom@aol.com
    Corresponding to the FDA made easy! Cut and copy. *When corresponding to the FDA please use the address below and it is important to insert in the subject the
    Message 1 of 1 , Nov 2, 2002
    • 0 Attachment
      Corresponding to the FDA made easy! Cut and copy.

      *When corresponding to the FDA please use the address below and it is
      important to insert in the subject the docket number:

      Address: fdadockets@...
      Subject: 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

      *the rest is blank and incomplete, FDA did not give a third page
      VerDate 0ct<09>2002 14:59 Oct 30, 2002 Jkt 200001 PO 00000 Frm 00025 Fmt 47
    Your message has been successfully submitted and would be delivered to recipients shortly.