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Federal Register / Vol. 70, No.

247 / Tuesday, December 27, 2005 / Notices 76461

Health Department Charge; a review of DEPARTMENT OF HEALTH AND collection of information to OMB for
the Top Five Priority Issues of the HDS HUMAN SERVICES review and clearance.
and how to proceed on the next top
Food and Drug Administration Reclassification Petitions for Medical
priority issues; a discussion on the
Devices—(OMB Control Number 0910–
formulation of recommendations on the [Docket No. 2005N–0350] 0138)—Extension
Environmental Health Workforce; a
discussion on issues the BSC would like Agency Information Collection FDA has the responsibility under
addressed; and a discussion to establish Activities; Submission for Office of sections 513(e), 513(f), 514(b), 515(b),
the regularity and timing of the HDS Management and Budget Review; and 520(l) of the Federal Food, Drug,
face-to-face and teleconference Comment Request; Reclassification and Cosmetic Act (the act) (21 U.S.C.
meetings. Petitions for Medical Devices 360c(e), 360c(f), 360d(b), 360e(b), and
Items are subject to change as 360j(l)) and part 860 (21 CFR part 860),
AGENCY: Food and Drug Administration, subpart C, to collect data and
priorities dictate. HHS. information contained in
SUPPLEMENTARY INFORMATION: This ACTION: Notice. reclassification petitions. The
teleconference meeting is scheduled to reclassification provisions of the act
begin at 1 p.m. e.s.t. To participate SUMMARY: The Food and Drug
allow any person to petition for
during the Public Comment period (2– Administration (FDA) is announcing reclassification of a device from any one
2:10 p.m.), dial (877) 315–6535, that a proposed collection of of the three classes (I, II, and III) to
conference code 383520. information has been submitted to the another class. The reclassification
Office of Management and Budget content regulation (§ 860.123) requires
FOR FURTHER INFORMATION CONTACT: (OMB) for review and clearance under
Individuals interested in attending the the submission of sufficient, valid
the Paperwork Reduction Act of 1995. scientific evidence demonstrating that
meeting, contact Sandra Malcom, DATES: Fax written comments on the
Committee Management Specialist, the proposed classification will provide
collection of information by January 26, a reasonable assurance of safety and
NCEH/ATSDR, 1600 Clifton Road, M/S 2006.
E–28, Atlanta, Georgia 30333; telephone effectiveness of the device for its
ADDRESSES: OMB is still experiencing intended use. The reclassification
404/498–0003, fax 404/498–0059; e-
mail: smalcom@cdc.gov. significant delays in the regular mail, provisions of the act serve primarily as
including first class and express mail, a vehicle for manufacturers to seek
The Director, Management Analysis and messenger deliveries are not being reclassification from a higher to a lower
and Services Office, has been delegated accepted. To ensure that comments on class, thereby reducing the regulatory
the authority to sign Federal Register the information collection are received, requirements applicable to a particular
notices pertaining to announcements of OMB recommends that comments be device. The reclassification petitions
meetings and other committee faxed to the Office of Information and requesting classification from class III to
management activities for both CDC and Regulatory Affairs, OMB, Attn: Fumie class II or class I, if approved, provide
the National Center for Environmental Yokota, Desk Officer for FDA, FAX: an alternative route to the market in lieu
Health/Agency for Toxic Substances 202–395–6974. of premarket approval for class III
and Disease Registry. devices.
FOR FURTHER INFORMATION CONTACT:
Dated: December 27, 2005. Denver Presley, Office of Management Respondents are device
Alvin Hall, Programs (HFA–250), Food and Drug manufacturers seeking reclassification.
Director, Management Analysis and Services Administration, 5600 Fishers Lane, In the Federal Register of September
Office Centers for Disease Control and Rockville, MD 20857, 301–827–1472. 14, 2005 (70 FR 54392), FDA published
Prevention. SUPPLEMENTARY INFORMATION: In a 60-day notice requesting public
[FR Doc. E5–7868 Filed 12–23–05; 8:45 am] compliance with 44 U.S.C. 3507, FDA comment on the information collection
BILLING CODE 4163–18–P has submitted the following proposed provisions. No comments were received.

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1


No. of Annual Frequency per Total Annual Hours per
21 CFR Section Total Hours
Respondents Response Responses Response

860.123 6 1 6 500 3,000


1There are no capital costs or operating and maintenance costs associated with this collection of information.
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76462 Federal Register / Vol. 70, No. 247 / Tuesday, December 27, 2005 / Notices

Based on current trends and actual reduced lead levels in their products FDA also is announcing the availability
reclassification petitions received, FDA consistent with the agency’s policy of of a draft document entitled
anticipates that six petitions will be reducing lead levels in the food supply ‘‘Supporting Document for
submitted each year. The time required to reduce consumers’ lead exposure to Recommended Maximum Level for Lead
to prepare and submit a reclassification the lowest level that practicably can be in Candy Likely To Be Consumed
petition, including the time needed to obtained. Frequently by Small Children.’’ The
assemble supporting data, averages 500 DATES: Submit written or electronic draft supporting document provides
hours per petition. This average is based comments on the draft guidance by additional background and rationale for
upon estimates by FDA administrative March 13, 2006. General comments on the recommended maximum level.
and technical staff that are familiar with agency guidance documents are These two documents are intended to
the requirements for submission of a welcome at any time. assist candy manufacturers in achieving
reclassification petition, have consulted ADDRESSES: Submit written requests for reduced lead levels in their products
and advised manufacturers on these single copies of the draft guidance and/ consistent with the agency’s policy of
requirements, and have reviewed the or draft supporting document to the reducing lead levels in the food supply
documentation submitted. Division of Plant Product Safety (HFS– to reduce consumers’ lead exposure to
Dated: December 8, 2005. 305), Center for Food Safety and the lowest level that practically can be
Jeffrey Shuren, Applied Nutrition, Food and Drug obtained.
Assistant Commissioner for Policy.
Administration, 5100 Paint Branch
Pkwy., College Park, MD 20740. Send The agency has adopted good
[FR Doc. E5–7804 Filed 12–23–05; 8:45 am] guidance practices (GGPs) that set forth
one self-addressed adhesive label to
BILLING CODE 4160–01–S
assist that office in processing your the agency’s policies and procedures for
requests. the development, issuance, and use of
Submit written comments on the draft guidance documents (21 CFR 10.115).
DEPARTMENT OF HEALTH AND guidance and/or draft supporting The draft guidance is being issued as a
HUMAN SERVICES document to the Division of Dockets level 1 draft guidance consistent with
Food and Drug Administration Management (HFA–305), Food and Drug GGPs. The draft guidance represents the
Administration, 5630 Fishers Lane, rm. agency’s current thinking on lead levels
[Docket No. 2005D–0481] 1061, Rockville, MD 20852. Submit in candy that are achievable with the
electronic comments to http:// use of good manufacturing practices in
Draft Guidance for Industry: Lead in www.fda.gov/dockets/ecomments. See the production of candy and candy
Candy Likely To Be Consumed the SUPPLEMENTARY INFORMATION section ingredients and that also provides for
Frequently by Small Children: for electronic access to the draft the protection of human health. It does
Recommended Maximum Level and guidance and draft supporting not create or confer any rights for or on
Enforcement Policy; Draft Supporting documents. any person and does not operate to bind
Document: Supporting Document for
FOR FURTHER INFORMATION CONTACT: FDA or the public. An alternative
Recommended Maximum Level for
Michael E. Kashtock, Center for Food approach may be used if such an
Lead in Candy Likely To Be Consumed
Safety and Applied Nutrition (HFS– approach satisfies the requirements of
Frequently by Small Children;
Availability 305), Food and Drug Administration, the applicable statutes and regulations.
5100 Paint Branch Pkwy., College Park,
II. Comments
AGENCY: Food and Drug Administration, MD 20740, 301–436–2022.
HHS. SUPPLEMENTARY INFORMATION: Interested persons may submit to the
ACTION: Notice. I. Background Division of Dockets Management (see
ADDRESSES) written or electronic
SUMMARY: The Food and Drug FDA is announcing the availability of comments on the draft guidance and
Administration (FDA) is announcing the a draft guidance for industry entitled draft supporting document. Submit a
availability of a draft guidance for ‘‘Lead in Candy Likely To Be Consumed single copy of electronic comments or
industry entitled ‘‘Lead in Candy Likely Frequently by Small Children:
two paper copies of any mailed
To Be Consumed Frequently by Small Recommended Maximum Level and
comments, except that individuals may
Children: Recommended Maximum Enforcement Policy.’’ This draft
submit one paper copy. Comments are
Level and Enforcement Policy.’’ This guidance provides a recommended
to be identified with the docket number
draft guidance provides a recommended maximum lead level in candy likely to
found in brackets in the heading of this
maximum lead level in candy likely to be consumed frequently by small
be consumed frequently by small children. FDA considers the document. The draft guidance and draft
children. FDA considers the recommended maximum level to be supporting document and received
recommended maximum level to be protective of human health and to be comments may be seen in the Division
protective of human health and to be achievable with the use of good of Dockets Management between 9 a.m.
achievable with the use of good manufacturing practices in the and 4 p.m., Monday through Friday.
manufacturing practices in the production of candy and candy III. Electronic Access
production of candy and candy ingredients. FDA notes that the
ingredients. The agency is also recommended level is not for Persons with access to the Internet
announcing the availability of a draft enforcement purposes. In addition, FDA may obtain the document at http://
supporting document entitled is rescinding previous guidance www.cfsan.fda.gov/guidance.html.
‘‘Supporting Document for provided in a 1995 letter to the industry Dated: December 14, 2005.
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Recommended Maximum Level for Lead regarding an enforcement level. Finally,


Jeffrey Shuren,
in Candy Likely To Be Consumed this draft guidance reiterates FDA’s
Frequently by Small Children.’’ These enforcement policy toward the use of Assistant Commissioner for Policy.
two documents are intended to assist lead based ink on candy wrappers as [FR Doc. 05–24494 Filed 12–22–05; 8:45 am]
candy manufacturers in achieving stated in the 1995 letter to the industry. BILLING CODE 4160–01–S

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