Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Reclassification Petitions for Medical Devices, 76461-76462 [E5-7804]
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Federal Register / Vol. 70, No. 247 / Tuesday, December 27, 2005 / Notices
76461
Health Department Charge; a review of
the Top Five Priority Issues of the HDS
and how to proceed on the next top
priority issues; a discussion on the
formulation of recommendations on the
Environmental Health Workforce; a
discussion on issues the BSC would like
addressed; and a discussion to establish
the regularity and timing of the HDS
face-to-face and teleconference
meetings.
Items are subject to change as
priorities dictate.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
collection of information to OMB for
review and clearance.
Food and Drug Administration
Reclassification Petitions for Medical
Devices—(OMB Control Number 0910–
0138)—Extension
This
teleconference meeting is scheduled to
begin at 1 p.m. e.s.t. To participate
during the Public Comment period (2–
2:10 p.m.), dial (877) 315–6535,
conference code 383520.
ACTION:
SUPPLEMENTARY INFORMATION:
FOR FURTHER INFORMATION CONTACT:
Individuals interested in attending the
meeting, contact Sandra Malcom,
Committee Management Specialist,
NCEH/ATSDR, 1600 Clifton Road, M/S
E–28, Atlanta, Georgia 30333; telephone
404/498–0003, fax 404/498–0059; email: smalcom@cdc.gov.
The Director, Management Analysis
and Services Office, has been delegated
the authority to sign Federal Register
notices pertaining to announcements of
meetings and other committee
management activities for both CDC and
the National Center for Environmental
Health/Agency for Toxic Substances
and Disease Registry.
Dated: December 27, 2005.
Alvin Hall,
Director, Management Analysis and Services
Office Centers for Disease Control and
Prevention.
[FR Doc. E5–7868 Filed 12–23–05; 8:45 am]
BILLING CODE 4163–18–P
[Docket No. 2005N–0350]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Reclassification
Petitions for Medical Devices
AGENCY:
Food and Drug Administration,
HHS.
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing
that a proposed collection of
information has been submitted to the
Office of Management and Budget
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
DATES: Fax written comments on the
collection of information by January 26,
2006.
ADDRESSES: OMB is still experiencing
significant delays in the regular mail,
including first class and express mail,
and messenger deliveries are not being
accepted. To ensure that comments on
the information collection are received,
OMB recommends that comments be
faxed to the Office of Information and
Regulatory Affairs, OMB, Attn: Fumie
Yokota, Desk Officer for FDA, FAX:
202–395–6974.
FOR FURTHER INFORMATION CONTACT:
Denver Presley, Office of Management
Programs (HFA–250), Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301–827–1472.
SUPPLEMENTARY INFORMATION: In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
FDA has the responsibility under
sections 513(e), 513(f), 514(b), 515(b),
and 520(l) of the Federal Food, Drug,
and Cosmetic Act (the act) (21 U.S.C.
360c(e), 360c(f), 360d(b), 360e(b), and
360j(l)) and part 860 (21 CFR part 860),
subpart C, to collect data and
information contained in
reclassification petitions. The
reclassification provisions of the act
allow any person to petition for
reclassification of a device from any one
of the three classes (I, II, and III) to
another class. The reclassification
content regulation (§ 860.123) requires
the submission of sufficient, valid
scientific evidence demonstrating that
the proposed classification will provide
a reasonable assurance of safety and
effectiveness of the device for its
intended use. The reclassification
provisions of the act serve primarily as
a vehicle for manufacturers to seek
reclassification from a higher to a lower
class, thereby reducing the regulatory
requirements applicable to a particular
device. The reclassification petitions
requesting classification from class III to
class II or class I, if approved, provide
an alternative route to the market in lieu
of premarket approval for class III
devices.
Respondents are device
manufacturers seeking reclassification.
In the Federal Register of September
14, 2005 (70 FR 54392), FDA published
a 60-day notice requesting public
comment on the information collection
provisions. No comments were received.
TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1
21 CFR Section
No. of
Respondents
860.123
bjneal on PROD1PC70 with NOTICES
1There
Annual Frequency per
Response
6
1
Total Annual
Responses
Hours per
Response
6
500
are no capital costs or operating and maintenance costs associated with this collection of information.
VerDate Aug<31>2005
14:54 Dec 23, 2005
Jkt 208001
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Frm 00020
Fmt 4703
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E:\FR\FM\27DEN1.SGM
Total Hours
27DEN1
3,000
76462
Federal Register / Vol. 70, No. 247 / Tuesday, December 27, 2005 / Notices
Based on current trends and actual
reclassification petitions received, FDA
anticipates that six petitions will be
submitted each year. The time required
to prepare and submit a reclassification
petition, including the time needed to
assemble supporting data, averages 500
hours per petition. This average is based
upon estimates by FDA administrative
and technical staff that are familiar with
the requirements for submission of a
reclassification petition, have consulted
and advised manufacturers on these
requirements, and have reviewed the
documentation submitted.
Dated: December 8, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E5–7804 Filed 12–23–05; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2005D–0481]
Draft Guidance for Industry: Lead in
Candy Likely To Be Consumed
Frequently by Small Children:
Recommended Maximum Level and
Enforcement Policy; Draft Supporting
Document: Supporting Document for
Recommended Maximum Level for
Lead in Candy Likely To Be Consumed
Frequently by Small Children;
Availability
AGENCY:
Food and Drug Administration,
HHS.
bjneal on PROD1PC70 with NOTICES
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing the
availability of a draft guidance for
industry entitled ‘‘Lead in Candy Likely
To Be Consumed Frequently by Small
Children: Recommended Maximum
Level and Enforcement Policy.’’ This
draft guidance provides a recommended
maximum lead level in candy likely to
be consumed frequently by small
children. FDA considers the
recommended maximum level to be
protective of human health and to be
achievable with the use of good
manufacturing practices in the
production of candy and candy
ingredients. The agency is also
announcing the availability of a draft
supporting document entitled
‘‘Supporting Document for
Recommended Maximum Level for Lead
in Candy Likely To Be Consumed
Frequently by Small Children.’’ These
two documents are intended to assist
candy manufacturers in achieving
VerDate Aug<31>2005
16:26 Dec 23, 2005
Jkt 208001
reduced lead levels in their products
consistent with the agency’s policy of
reducing lead levels in the food supply
to reduce consumers’ lead exposure to
the lowest level that practicably can be
obtained.
DATES: Submit written or electronic
comments on the draft guidance by
March 13, 2006. General comments on
agency guidance documents are
welcome at any time.
ADDRESSES: Submit written requests for
single copies of the draft guidance and/
or draft supporting document to the
Division of Plant Product Safety (HFS–
305), Center for Food Safety and
Applied Nutrition, Food and Drug
Administration, 5100 Paint Branch
Pkwy., College Park, MD 20740. Send
one self-addressed adhesive label to
assist that office in processing your
requests.
Submit written comments on the draft
guidance and/or draft supporting
document to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852. Submit
electronic comments to https://
www.fda.gov/dockets/ecomments. See
the SUPPLEMENTARY INFORMATION section
for electronic access to the draft
guidance and draft supporting
documents.
FOR FURTHER INFORMATION CONTACT:
Michael E. Kashtock, Center for Food
Safety and Applied Nutrition (HFS–
305), Food and Drug Administration,
5100 Paint Branch Pkwy., College Park,
MD 20740, 301–436–2022.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of
a draft guidance for industry entitled
‘‘Lead in Candy Likely To Be Consumed
Frequently by Small Children:
Recommended Maximum Level and
Enforcement Policy.’’ This draft
guidance provides a recommended
maximum lead level in candy likely to
be consumed frequently by small
children. FDA considers the
recommended maximum level to be
protective of human health and to be
achievable with the use of good
manufacturing practices in the
production of candy and candy
ingredients. FDA notes that the
recommended level is not for
enforcement purposes. In addition, FDA
is rescinding previous guidance
provided in a 1995 letter to the industry
regarding an enforcement level. Finally,
this draft guidance reiterates FDA’s
enforcement policy toward the use of
lead based ink on candy wrappers as
stated in the 1995 letter to the industry.
PO 00000
Frm 00021
Fmt 4703
Sfmt 4703
FDA also is announcing the availability
of a draft document entitled
‘‘Supporting Document for
Recommended Maximum Level for Lead
in Candy Likely To Be Consumed
Frequently by Small Children.’’ The
draft supporting document provides
additional background and rationale for
the recommended maximum level.
These two documents are intended to
assist candy manufacturers in achieving
reduced lead levels in their products
consistent with the agency’s policy of
reducing lead levels in the food supply
to reduce consumers’ lead exposure to
the lowest level that practically can be
obtained.
The agency has adopted good
guidance practices (GGPs) that set forth
the agency’s policies and procedures for
the development, issuance, and use of
guidance documents (21 CFR 10.115).
The draft guidance is being issued as a
level 1 draft guidance consistent with
GGPs. The draft guidance represents the
agency’s current thinking on lead levels
in candy that are achievable with the
use of good manufacturing practices in
the production of candy and candy
ingredients and that also provides for
the protection of human health. 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 an
approach satisfies the requirements of
the applicable statutes and regulations.
II. Comments
Interested persons may submit to the
Division of Dockets Management (see
ADDRESSES) written or electronic
comments on the draft guidance and
draft supporting 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. The draft guidance and draft
supporting document and received
comments may be seen in the Division
of Dockets Management between 9 a.m.
and 4 p.m., Monday through Friday.
III. Electronic Access
Persons with access to the Internet
may obtain the document at https://
www.cfsan.fda.gov/guidance.html.
Dated: December 14, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05–24494 Filed 12–22–05; 8:45 am]
BILLING CODE 4160–01–S
E:\FR\FM\27DEN1.SGM
27DEN1
]]>Agencies
[Federal Register Volume 70, Number 247 (Tuesday, December 27, 2005)]
[Notices]
[Pages 76461-76462]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E5-7804]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2005N-0350]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Reclassification
Petitions for Medical Devices
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing that a
proposed collection of information has been submitted to the Office of
Management and Budget (OMB) for review and clearance under the
Paperwork Reduction Act of 1995.
DATES: Fax written comments on the collection of information by January
26, 2006.
ADDRESSES: OMB is still experiencing significant delays in the regular
mail, including first class and express mail, and messenger deliveries
are not being accepted. To ensure that comments on the information
collection are received, OMB recommends that comments be faxed to the
Office of Information and Regulatory Affairs, OMB, Attn: Fumie Yokota,
Desk Officer for FDA, FAX: 202-395-6974.
FOR FURTHER INFORMATION CONTACT: Denver Presley, Office of Management
Programs (HFA-250), Food and Drug Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301-827-1472.
SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.
Reclassification Petitions for Medical Devices--(OMB Control Number
0910-0138)--Extension
FDA has the responsibility under sections 513(e), 513(f), 514(b),
515(b), and 520(l) of the Federal Food, Drug, and Cosmetic Act (the
act) (21 U.S.C. 360c(e), 360c(f), 360d(b), 360e(b), and 360j(l)) and
part 860 (21 CFR part 860), subpart C, to collect data and information
contained in reclassification petitions. The reclassification
provisions of the act allow any person to petition for reclassification
of a device from any one of the three classes (I, II, and III) to
another class. The reclassification content regulation (Sec. 860.123)
requires the submission of sufficient, valid scientific evidence
demonstrating that the proposed classification will provide a
reasonable assurance of safety and effectiveness of the device for its
intended use. The reclassification provisions of the act serve
primarily as a vehicle for manufacturers to seek reclassification from
a higher to a lower class, thereby reducing the regulatory requirements
applicable to a particular device. The reclassification petitions
requesting classification from class III to class II or class I, if
approved, provide an alternative route to the market in lieu of
premarket approval for class III devices.
Respondents are device manufacturers seeking reclassification.
In the Federal Register of September 14, 2005 (70 FR 54392), FDA
published a 60-day notice requesting public comment on the information
collection provisions. No comments were received.
Table 1.--Estimated Annual Reporting Burden\1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
No. of Annual Frequency per Total Annual Hours per
21 CFR Section Respondents Response Responses Response Total Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
860.123 6 1 6 500 3,000
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\There are no capital costs or operating and maintenance costs associated with this collection of information.
[[Page 76462]]
Based on current trends and actual reclassification petitions
received, FDA anticipates that six petitions will be submitted each
year. The time required to prepare and submit a reclassification
petition, including the time needed to assemble supporting data,
averages 500 hours per petition. This average is based upon estimates
by FDA administrative and technical staff that are familiar with the
requirements for submission of a reclassification petition, have
consulted and advised manufacturers on these requirements, and have
reviewed the documentation submitted.
Dated: December 8, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E5-7804 Filed 12-23-05; 8:45 am]
BILLING CODE 4160-01-S
