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Federal Register / Vol. 70, No.

235 / Thursday, December 8, 2005 / Notices 73009

Dated: December 1, 2005. DEPARTMENT OF HEALTH AND provide information to a third party.
Joan Karr, HUMAN SERVICES Section 3506(c)(2)(A) of the PRA (44
Acting Reports Clearance Officer, Centers for U.S.C. 3506(c)(2)(A)) requires Federal
Disease Control and Prevention. Food and Drug Administration agencies to provide a 60-day notice in
[FR Doc. E5–7040 Filed 12–7–05; 8:45 am] [Docket No. 2005N–0457] the Federal Register concerning each
proposed collection of information,
BILLING CODE 4163–18–P
Agency Information Collection including each proposed extension of an
Activities; Proposed Collection; existing collection of information,
DEPARTMENT OF HEALTH AND Comment Request; Notice of a Claim before submitting the collection to OMB
HUMAN SERVICES for Generally Recognized as Safe for approval. To comply with this
Exemption Based on a Generally requirement, FDA is publishing notice
Food and Drug Administration Recognized as Safe Determination of the proposed collection of
information set forth in this document.
AGENCY: Food and Drug Administration, With respect to the following
[Docket No. 2005N–0186] HHS. collection of information, FDA invites
ACTION: Notice. comments on these topics: (1) Whether
Agency Information Collection
Activities; Announcement of Office of the proposed collection of information
SUMMARY: The Food and Drug
Management and Budget Approval; is necessary for the proper performance
Administration (FDA) is announcing an
of FDA’s functions, including whether
State Enforcement Notifications opportunity for public comment on the
the information will have practical
proposed collection of certain
AGENCY: Food and Drug Administration, utility; (2) the accuracy of FDA’s
information by the agency. Under the
HHS. estimate of the burden of the proposed
Paperwork Reduction Act of 1995 (the
collection of information, including the
PRA), Federal agencies are required to
ACTION: Notice. validity of the methodology and
publish notice in the Federal Register
assumptions used; (3) ways to enhance
concerning each proposed collection of
SUMMARY: The Food and Drug the quality, utility, and clarity of the
information, including each proposed
Administration (FDA) is announcing information to be collected; and (4)
extension of an existing collection of
that a collection of information entitled ways to minimize the burden of the
information, and to allow 60 days for
‘‘State Enforcement Notifications’’ has collection of information on
public comment in response to the
been approved by the Office of respondents, including through the use
notice. This notice solicits comments on
Management and Budget (OMB) under of automated collection techniques,
the procedures used for submitting a
the Paperwork Reduction Act of 1995. when appropriate, and other forms of
Generally Recognized as Safe (GRAS)
information technology.
FOR FURTHER INFORMATION CONTACT: notice stating that a particular use of a
Peggy Robbins, Office of Management substance is not subject to the premarket Notice of a Claim for GRAS Exemption
approval requirements of the Federal Based on a GRAS Determination—21
Programs (HFA–250), Food and Drug
Food, Drug, and Cosmetic Act (the act). CFR 170.36 and 570.36 (OMB Control
Administration, 5600 Fishers Lane,
DATES: Submit written or electronic Number 0910–0342)—Extension
Rockville, MD 20857, 301–827–1223.
comments on the collection of Section 409 of the act (21 U.S.C. 348)
SUPPLEMENTARY INFORMATION: In the information by February 6, 2006. establishes a premarket approval
Federal Register of September 14, 2005 ADDRESSES: Submit electronic requirement for ‘‘food additives;’’
(70 FR 54393), the agency announced comments on the collection of section 201(s) of the act (21 U.S.C.
that the proposed information collection information to http://www.fda.gov/ 321(s)) provides an exemption from the
had been submitted to OMB for review dockets/ecomments. Submit written definition of ‘‘food additive’’ and thus
and clearance under 44 U.S.C. 3507. An comments on the collection of from the premarket approval
agency may not conduct or sponsor, and information to the Division of Dockets requirement, for uses of substances that
a person is not required to respond to, Management (HFA–305), Food and Drug are GRAS by qualified experts. FDA is
a collection of information unless it Administration, 5630 Fishers Lane, rm. proposing a voluntary procedure
displays a currently valid OMB control 1061, Rockville, MD 20852. All whereby members of the food industry
number. OMB has now approved the comments should be identified with the who determine that use of a substance
information collection and has assigned docket number found in brackets in the satisfies the statutory exemption may
OMB control number 0910–0275. The heading of this document. notify FDA of that determination. The
approval expires on November 30, 2008. FOR FURTHER INFORMATION CONTACT: notice would include a detailed
A copy of the supporting statement for Peggy Robbins, Office of Management summary of the data and information
this information collection is available Programs (HFA–250), Food and Drug that support the GRAS determination,
on the Internet at ‘‘http://www.fda.gov/ Administration, 5600 Fishers Lane, and the notifier would maintain a
ohrms/dockets’’. Rockville, MD 20857, 301–827–1223. record of such data and information.
SUPPLEMENTARY INFORMATION: Under the FDA would make the information
Dated: November 30, 2005.
PRA (44 U.S.C. 3501–3520), Federal describing the GRAS claim, and the
Jeffrey Shuren, agencies must obtain approval from the agency’s response to the notice,
Assistant Commissioner for Policy. Office of Management and Budget available in a publicly accessible file;
[FR Doc. 05–23744 Filed 12–7–05; 8:45 am] (OMB) for each collection of the entire GRAS notice would be
BILLING CODE 4160–01–S information they conduct or sponsor. publicly available consistent with the
‘‘Collection of information’’ is defined Freedom of Information Act and other
in 44 U.S.C. 3502(3) and 5 CFR Federal disclosure statutes.
1320.3(c) and includes agency requests Description of Respondents:
or requirements that members of the Manufacturers of Substances Used in
public submit reports, keep records, or Food and Feed.

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73010 Federal Register / Vol. 70, No. 235 / Thursday, December 8, 2005 / Notices

FDA estimates the burden of this


collection of information as follows:

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1


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

170.36 50 1 50 150 7,500


570.36 10 1 10 150 1,500
Total 9,000
1There are no capital costs or operating and maintenance costs associated with this collection of information.

TABLE 2.—ESTIMATED ANNUAL RECORDKEEPING BURDEN1


No. of Record- Annual Frequency per Hours per
21 CFR Section Total Annual Records Total Hours
keepers Recordkeeping Recordkeeper

170.36(c)(v) 50 1 50 15 750
570.36(c)(v) 10 1 10 15 150
Total 900
1There are no capital costs or operating and maintenance costs associated with this collection of information.

The reporting requirement is for a DEPARTMENT OF HEALTH AND FAX your request to 301–443–8818. See
proposed rule that has not yet been HUMAN SERVICES the SUPPLEMENTARY INFORMATION section
issued as a final rule. In developing the for information on electronic access to
proposed rule, FDA solicited input from Food and Drug Administration the guidance.
representatives of the food industry on Submit written comments concerning
[Docket No. 2005D–0434]
the reporting requirements, but could this guidance to the Division of Dockets
not fully discuss with those Draft Guidance for Industry and Food Management (HFA–305), Food and Drug
representatives the details of the and Drug Administration; Nucleic Acid Administration, 5630 Fishers Lane, rm.
proposed notification procedure. FDA Based In Vitro Diagnostic Devices for 1061, Rockville, MD 20852. Submit
received no comments on the agency’s Detection of Microbial Pathogens; electronic comments to http://
estimate of the hourly reporting Availability www.fda.gov/dockets/ecomments.
Identify comments with the docket
requirements, and thus has no basis to AGENCY: Food and Drug Administration, number found in brackets in the
revise that estimate at this time. In 1998, HHS. heading of this document.
FDA began receiving notices that were
ACTION: Notice. FOR FURTHER INFORMATION CONTACT:
submitted under the terms of the
proposed rule. Since it began receiving Roxanne Shively, Center for Devices
SUMMARY: The Food and Drug and Radiological Health (HFZ–440),
notices, FDA has received 12 in 1998, Administration (FDA) is announcing the Food and Drug Administration, 2098
23 in 1999, 30 in 2000, 28 in 2001, 26 availability of the draft guidance Gaither Rd., Rockville, MD 20850, 240–
in 2002, 23 in 2003, 20 in 2004, and 22 entitled ‘‘Nucleic Acid Based In Vitro 276–0496 ext. 113.
to date in 2005, notices annually. To Diagnostic Devices for Detection of
SUPPLEMENTARY INFORMATION:
date, the number of annual notices is Microbial Pathogens.’’ This draft
less than FDA’s estimate; however, the guidance document is being issued to I. Background
number of annual notices could increase provide guidance on the types of This draft document is intended to
when the proposed rule becomes final. information and data to consider when provide a basic framework for the types
FDA received 23 notices in 1999, 30 preparing or reviewing premarket of information and data that we believe
notices in 2000, 28 notices in 2001, 26 submissions for nucleic acid based in should be addressed in the premarket
notices in 2002, 23 notices in 2003, and vitro diagnostic devices for the review of a nucleic acid based device for
20 notices in 2004. detection of microbial pathogens. detecting microbial pathogens. This
DATES: Submit written or electronic draft guidance replaces a previously
Dated: November 30, 2005.
comments on this draft guidance by issued document entitled ‘‘Review
Jeffrey Shuren, March 8, 2006. Criteria for Nucleic Acid Amplification-
Assistant Commissioner for Policy.
ADDRESSES: Submit written requests for based in vitro Diagnostic Devices for
[FR Doc. 05–23747 Filed 12–7–05; 8:45 am] single copies on a 3.5’’ diskette of the Direct Detection of Infectious
BILLING CODE 4160–01–S guidance document entitled ‘‘Nucleic Microorganisms’’ (June 1993). The
Acid Based In Vitro Diagnostic Devices current draft reflects changes in the
for Detection of Microbial Pathogens’’ to technologies available for nucleic acid
the Division of Small Manufacturers, detection, and expanded use in clinical
International, and Consumer Assistance laboratories. The recommendations
(HFZ–220), Center for Devices and within this draft guidance apply broadly
Radiological Health, Food and Drug to premarket review of these in vitro
Administration, 1350 Piccard Dr., diagnostic devices for detecting
Rockville, MD 20850. Send one self- microbial pathogens. Enzymatic
addressed adhesive label to assist that amplification may or may not be part of
office in processing your request, or the applied technology.

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