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Federal Register / Vol. 70, No.

162 / Tuesday, August 23, 2005 / Notices 49295

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1—Continued


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

Total 4,000
1There are no capital costs or operating and maintenance costs associated with this collection of information.

In the Federal Register of May 3, 2005 Dated: August 17, 2005. Administration, 5600 Fishers Lane,
(70 FR 22887), FDA published a 60-day Jeffrey Shuren, Rockville, MD 20857, 301–827–1223.
notice requesting public comment on Assistant Commissioner for Policy. SUPPLEMENTARY INFORMATION: Under the
the information collection provisions. [FR Doc. 05–16657 Filed 8–22–05; 8:45 am] PRA (44 U.S.C. 3501–3520), Federal
No comments were received. BILLING CODE 4160–01–S agencies must obtain approval from the
Dated: August 17, 2005. Office of Management and Budget
Jeffrey Shuren, (OMB) for each collection of
Assistant Commissioner for Policy. DEPARTMENT OF HEALTH AND information they conduct or sponsor.
HUMAN SERVICES ‘‘Collection of information’’ is defined
[FR Doc. 05–16656 Filed 8–22–05; 8:45 am]
in 44 U.S.C. 3502(3) and 5 CFR
BILLING CODE 4160–01–S Food and Drug Administration 1320.3(c) and includes agency requests
or requirements that members of the
[Docket No. 2005N–0317]
public submit reports, keep records, or
DEPARTMENT OF HEALTH AND
Agency Information Collection provide information to a third party.
HUMAN SERVICES
Activities; Proposed Collection; Section 3506(c)(2)(A) of the PRA (44
Food and Drug Administration Comment Request; Record Retention U.S.C. 3506(c)(2)(A)) requires Federal
Requirements for the Soy Protein and agencies to provide a 60-day notice in
Risk of Coronary Heart Disease Health the Federal Register concerning each
[Docket No. 2005N–0029] proposed collection of information,
Claim
Agency Information Collection including each proposed extension of an
Activities; Announcement of Office of AGENCY: Food and Drug Administration, existing collection of information,
Management and Budget Approval; HHS. before submitting the collection to OMB
ACTION: Notice. for approval. To comply with this
Infant Formula Recall Regulations
requirement, FDA is publishing notice
AGENCY: Food and Drug Administration, SUMMARY: The Food and Drug of the proposed collection of
HHS. Administration (FDA) is announcing an information set forth in this document.
opportunity for public comment on the With respect to the following
ACTION: Notice. proposed collection of certain collection of information, FDA invites
information by the agency. Under the comments on these topics: (1) Whether
SUMMARY: The Food and Drug Paperwork Reduction Act of 1995 (the the proposed collection of information
Administration (FDA) is announcing PRA), Federal agencies are required to is necessary for the proper performance
that a collection of information entitled publish notice in the Federal Register of FDA’s functions, including whether
‘‘Infant Formula Recall Regulations’’ has concerning each proposed collection of the information will have practical
been approved by the Office of information, including each proposed utility; (2) the accuracy of FDA’s
Management and Budget (OMB) under extension of an existing collection of estimate of the burden of the proposed
the Paperwork Reduction Act of 1995. information, and to allow 60 days for collection of information, including the
FOR FURTHER INFORMATION CONTACT: public comment in response to the validity of the methodology and
Peggy Robbins, Office of Management notice. This notice solicits comments on assumptions used; (3) ways to enhance
Programs (HFA–250), Food and Drug the record retention requirement of the the quality, utility, and clarity of the
Administration, 5600 Fishers Lane, soy protein/coronary heart disease information to be collected; and (4)
Rockville, MD 20857, 301–827–1223. health claim. ways to minimize the burden of the
DATES: Submit written or electronic
collection of information on
SUPPLEMENTARY INFORMATION: In the respondents, including through the use
Federal Register of February 1, 2005 (70 comments on the collection of
information by October 24, 2005. of automated collection techniques,
FR 5188), the agency announced that when appropriate, and other forms of
the proposed information collection had ADDRESSES: Submit electronic
information technology.
been submitted to OMB for review and comments on the collection of
clearance under 44 U.S.C. 3507. An information to: http://www.fda.gov/ Record Retention Requirements for the
agency may not conduct or sponsor, and dockets/ecomments. Submit written Soy Protein and Risk of Coronary Heart
a person is not required to respond to, comments on the collection of Disease Health Claim—21 CFR
a collection of information unless it information to the Division of Dockets 101.82(c)(2)(ii)(B) (OMB Control
displays a currently valid OMB control Management (HFA–305), Food and Drug Number 0910–0428)—Extension
number. OMB has now approved the Administration, 5630 Fishers Lane, rm. Section 403(r)(3)(A)(i) of the Federal
information collection and has assigned 1061, Rockville, MD 20852. All Food, Drug, and Cosmetic Act (21 U.S.C.
OMB control number 0910–0188. The comments should be identified with the 343(r)(3)(A)(i)) provides for the use of
approval expires on July 31, 2008. A docket number found in brackets in the food label statements characterizing a
copy of the supporting statement for this heading of this document. relationship of any nutrient of the type
information collection is available on FOR FURTHER INFORMATION CONTACT: required to be in the label or labeling of
the Internet at http://www.fda.gov/ Peggy Robbins, Office of Management the food to a disease or a health related
ohrms/dockets. Programs (HFA–250), Food and Drug condition only where that statement

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49296 Federal Register / Vol. 70, No. 162 / Tuesday, August 23, 2005 / Notices

meets the requirements of the protein in foods that contain soy as the protein in a food that bears the health
regulations promulgated by the sole source of protein. However, at the claim and contains sources of protein
Secretary to authorize the use of such a present time there is no validated other than soy, and to make such
health claim. Section 101.82 (21 CFR analytical methodology available to records available to appropriate
101.82) of FDA’s regulations authorizes quantify the amount of soy protein in regulatory officials upon written
a health claim for food labels about soy foods that contain other sources of request. The information collected
protein and the risk of coronary heart protein. For these latter foods, FDA includes nutrient data bases or analyses,
disease. To bear the soy protein/ must rely on information known only to recipes or formulations, purchase orders
coronary heart disease health claim, the manufacturer to assess compliance for ingredients, or any other information
foods must contain at least 6.25 grams with the requirement that the food that reasonably substantiates the ratio of
of soy protein per reference amount contain the qualifying amount of soy
soy protein to total protein.
customarily consumed. Analytical protein. Thus, FDA requires
methods for measuring total protein can manufacturers to have and keep records FDA estimates the burden of this
be used to quantify the amount of soy to substantiate the amount of soy collection of information as follows:

TABLE 1.—ESTIMATED ANNUAL RECORDKEEPING BURDEN1


Annual Frequency per Total Annual Hours per
21 CFR Section No. of Recordkeepers Total Hours
Recordkeeping Records Record

101.82(c)(2)(ii)(B) 25 1 25 1 25
1There are no capital costs or operating and maintenance costs associated with this collection of information.

Based upon its experience with the ‘‘Adverse Experience Reporting for DEPARTMENT OF HEALTH AND
use of health claims, FDA estimates that Licensed Biological Products; and HUMAN SERVICES
only about 25 firms would be likely to General Records’’ has been approved by
market products bearing a soy protein/ the Office of Management and Budget Food and Drug Administration
coronary heart disease health claim and (OMB) under the Paperwork Reduction [Docket No. 2005D–0310]
that only, perhaps, one of each firm’s Act of 1995.
products might contain nonsoy sources Draft Guidance for Industry on Gene
of protein along with soy protein. The FOR FURTHER INFORMATION CONTACT:
Therapy Clinical Trials—Observing
records required to be retained by Jonna Capezzuto, Office of Management Participants for Delayed Adverse
§ 101.82(c)(2)(ii)(B) are the records, e.g., Programs (HFA–250), Food and Drug Events; Availability
the formulation or recipe, that a Administration, 5600 Fishers Lane,
manufacturer has and maintains as a Rockville, MD 20857, 301–827–4659. AGENCY: Food and Drug Administration,
normal course of its doing business. HHS.
SUPPLEMENTARY INFORMATION: In the
Thus, the burden to the food ACTION: Notice.
Federal Register of April 20, 2005 (70
manufacturer is that involved in
FR 20571), the agency announced that SUMMARY: The Food and Drug
assembling and providing the records to
the proposed information collection had Administration (FDA) is announcing the
appropriate regulatory officials for
review or copying. been submitted to OMB for review and availability of a draft document entitled
clearance under 44 U.S.C. 3507. An ‘‘Guidance for Industry: Gene Therapy
Dated: August 17, 2005. agency may not conduct or sponsor, and Clinical Trials—Observing Participants
Jeffrey Shuren, a person is not required to respond to, for Delayed Adverse Events,’’ dated
Assistant Commissioner for Policy. a collection of information unless it August 2005. The draft guidance
[FR Doc. 05–16658 Filed 8–22–05; 8:45 am] displays a currently valid OMB control provides sponsors of gene therapy
BILLING CODE 4160–01–S number. OMB has now approved the studies with recommendations
information collection and has assigned regarding collection of data on delayed
OMB control number 0910–0308. The adverse events in participants who have
DEPARTMENT OF HEALTH AND approval expires on July 31, 2008. A been exposed to gene therapy products.
HUMAN SERVICES When finalized, this guidance will
copy of the supporting statement for this
information collection is available on supplement the recommendations in the
Food and Drug Administration ‘‘Guidance for Industry: Supplemental
the Internet at http://www.fda.gov/
[Docket No. 2004N–0469] ohrms/dockets. Guidance on Testing for Replication
Competent Retrovirus in Retroviral
Agency Information Collection Dated: August 17, 2005. Vector Based Gene Therapy Products
Activities; Announcement of Office of Jeffrey Shuren, and During Follow-up of Patients in
Management and Budget Approval; Assistant Commissioner for Policy. Clinical Trials Using Retroviral Vectors’’
Adverse Experience Reporting for [FR Doc. 05–16659 Filed 8–22–05; 8:45 am] (Retroviral Vector guidance), dated
Licensed Biological Products; and October 2000, for study participant
BILLING CODE 4160–01–S
General Records long-term followup. However, the
AGENCY: Food and Drug Administration, recommendations in the Retroviral
HHS. Vector guidance regarding the length of
followup will be superseded by this
ACTION: Notice.
Gene Therapy Clinical Trials guidance.
SUMMARY: The Food and Drug DATES: Submit written or electronic
Administration (FDA) is announcing comments on the draft guidance by
that a collection of information entitled November 21, 2005, to ensure their

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