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35098 Federal Register / Vol. 70, No.

115 / Thursday, June 16, 2005 / Notices

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN 1—Continued


No. of No. of responses Total annual Hours per
Section of the act/basis of burden respondents per respondent responses response Total hours

Guidance for notifications 3 1 3 1 3

Total 1,153
1 There are no capital costs or operating and maintenance costs associated with this collection of information.

These estimates are based on FDA’s DATES: Submit written or electronic information to be collected; and (4)
experience with health claims, nutrient comments on the collection of ways to minimize the burden of the
content claims, and other similar information by August 15, 2005. collection of information on
notification procedures that fall under ADDRESSES: Submit electronic respondents, including through the use
the agency’s jurisdiction. Because the comments on the collection of of automated collection techniques,
claims are based on an authoritative information to: http://www.fda.gov/ when appropriate, and other forms of
statement of certain scientific bodies of dockets/ecomments. Submit written information technology.
the Federal Government or the National comments on the collection of
Academy of Sciences or one of its information to the Division of Dockets Medical Devices: Humanitarian Use
subdivisions, FDA believes that the Management (HFA–305), Food and Drug Devices—21 CFR Part 814 (OMB
information submitted with a Administration, 5630 Fishers Lane, rm. Control Number 0910–0332)—Extension
notification will either be provided as 1061, Rockville, MD 20852. All This collection implements the
part of the authoritative statement, or comments should be identified with the humanitarian use device (HUD)
readily available as part of the scientific docket number found in brackets in the Provision under section 520(m) of the
literature to firms wishing to make heading of this document. Federal Food, Drug, and Cosmetic Act
claims. Presentation of a supporting FOR FURTHER INFORMATION CONTACT: (the act) (21 U.S.C. 360j(m)) and 21 CFR
bibliography and a brief balanced Peggy Robbins, Office of Management part 814, subpart H. Under section
account or analysis of this literature Programs (HFA–250), Food and Drug 520(m) of the act, FDA is authorized to
should be fairly straightforward. Administration, 5600 Fishers Lane, exempt an HUD from the effectiveness
Dated: June 9, 2005. Rockville, MD 20857, 301–827–1223. requirements of sections 514 and 515 of
Jeffrey Shuren, SUPPLEMENTARY INFORMATION: Under the the act (21 U.S.C. 360d and 360e)
Assistant Commissioner for Policy. PRA (44 U.S.C. 3501–3520), Federal provided that the device do the
[FR Doc. 05–11860 Filed 6–15–05; 8:45 am]
agencies must obtain approval from the following: (1) Is used to treat or
Office of Management and Budget diagnosis a disease or condition that
BILLING CODE 4160–01–S
(OMB) for each collection of affects fewer than 4,000 individuals in
information they conduct or sponsor. the United States; (2) would not be
DEPARTMENT OF HEALTH AND ‘‘Collection of information’’ is defined available to a person with such a disease
HUMAN SERVICES in 44 U.S.C. 3502(3) and 5 CFR or condition unless the exemption is
1320.3(c) and includes agency requests granted, and there is no comparable
Food and Drug Administration or requirements that members of the
device, other than another HUD
public submit reports, keep records, or
[Docket No. 2005N–0216] approved under this exemption,
provide information to a third party.
available to treat or diagnose the disease
Section 3506(c)(2)(A) of the PRA (44
Agency Information Collection or condition; and (3) the device will not
U.S.C. 3506(c)(2)(A)) requires Federal
Activities; Proposed Collection; expose patients to an unreasonable or
agencies to provide a 60-day notice in
Comment Request; Medical Devices: significant risk of illness or injury, and
the Federal Register concerning each
Humanitarian Use Devices the probable benefit to health from
proposed collection of information,
including each proposed extension of an using the device outweighs the risk of
AGENCY: Food and Drug Administration,
existing collection of information before injury or illness from its use, taking into
HHS.
submitting the collection to OMB for account the probable risks and benefits
ACTION: Notice. of currently available devices or
approval. To comply with this
SUMMARY: The Food and Drug requirement, FDA is publishing notice alternative forms of treatment.
Administration (FDA) is announcing an of the proposed collection of The information collection will allow
opportunity for public comment on the information set forth in this document. FDA to determine whether to do the
proposed collection of certain With respect to the following following: (1) Grant HUD designation of
information by the agency. Under the collection of information, FDA invites a medical device, (2) exempt a HUD
Paperwork Reduction Act of 1995 (the comments on these topics: (1) Whether from the effectiveness requirements in
PRA), Federal agencies are required to the proposed collection of information sections 514 and 515 of the act provided
publish notice in the Federal Register is necessary for the proper performance that the device meets requirements set
concerning each proposed collection of of FDA’s functions, including whether forth in section 520(m) of the act, and
information, including each proposed the information will have practical (3) grants marketing approval(s) for the
extension of an existing collection of utility; (2) the accuracy of FDA’s HUD. Failure to collect this information
information, and to allow 60 days for estimate of the burden of the proposed would prevent FDA from making those
public comment in response to the collection of information, including the determinations. Also, this information
notice. This notice solicits comments on validity of the methodology and enables FDA to determine whether the
information collection requirements for assumptions used; (3) ways to enhance holder of a HUD is in compliance with
Humanitarian Use Devices. the quality, utility, and clarity of the the HUD requirements.

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Federal Register / Vol. 70, No. 115 / Thursday, June 16, 2005 / Notices 35099

Description of Respondents: FDA estimates the burden of this


Businesses or others for-profit. collection of information as follows:

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1


Annual Frequency per Total Annual Re-
21 CFR Section No. of Respondents Hours per Response Total Hours
Response sponses

814.102 20 1 20 40 800

814.104 8 1 8 320 2,560

814.106 8 2 16 50 800

814.108 20 1 20 80 1,600

814.116(e)(3) 1 1 1 1 1

814.124(a) 5 1 5 1 5

814.124(b) 1 1 1 2 2

814.126(b)(1) 35 1 35 120 4,200

Total 9,968
1There are no capital costs or operating and maintenance costs associated with this collection of information.

TABLE 2.—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1


Annual frequency per
21 CFR Section No. of recordkeepers Total annual records Hours per record Total hours
recordkeeping

814.126(b)(2) 35 1 35 2 70
1 There are no capital costs or operating and maintenance costs associated with this collection of information.

Dated: June 9, 2005. Administration, 5600 Fishers Lane, DEPARTMENT OF HEALTH AND
Jeffrey Shuren, Rockville, MD 20857, 301–827–1482. HUMAN SERVICES
Assistant Commissioner for Policy.
SUPPLEMENTARY INFORMATION: In the Food and Drug Administration
[FR Doc. 05–11861 Filed 6–15–05; 8:45 am]
Federal Register of January 31, 2005 (70
BILLING CODE 4160–01–S
FR 4853), the agency announced that
[Docket No. 2005N–0208]
the proposed information collection had
DEPARTMENT OF HEALTH AND been submitted to OMB for review and Agency Information Collection
HUMAN SERVICES clearance under 44 U.S.C. 3507. An Activities; Proposed Collection;
agency may not conduct or sponsor, and Comment Request; Dissemination of
Food and Drug Administration a person is not required to respond to, Information on Unapproved/New Uses
a collection of information unless it for Marketed Drugs, Biologics, and
[Docket No. 2004N–0441]
displays a currently valid OMB control Devices
Agency Information Collection number. OMB has now approved the
information collection and has assigned AGENCY: Food and Drug Administration,
Activities; Announcement of Office of
OMB control number 0910–0001. The HHS.
Management and Budget Approval;
Application for Food and Drug approval expires on May 31, 2008. A ACTION: Notice.
Administration Approval to Market a copy of the supporting statement for this
New Drug information collection is available on SUMMARY: The Food and Drug
the Internet at http://www.fda.gov/ Administration (FDA) is announcing an
AGENCY: Food and Drug Administration, opportunity for public comment on the
ohrms/dockets.
HHS. proposed collection of certain
ACTION: Notice. Dated: June 9, 2005. information by the agency. Under the
Jeffrey Shuren, Paperwork Reduction Act of 1995 (the
SUMMARY: The Food and Drug Assistant Commissioner for Policy. PRA), Federal agencies are required to
Administration (FDA) is announcing [FR Doc. 05–11862 Filed 6–15–05; 8:45 am] publish notice in the Federal Register
that a collection of information entitled concerning each proposed collection of
BILLING CODE 4160–01–S
‘‘Application for FDA Approval to information, including each proposed
Market a New Drug’’ has been approved extension of an existing collection of
by the Office of Management and information, and to allow 60 days for
Budget (OMB) under the Paperwork public comment in response to the
Reduction Act of 1995. notice. This notice solicits comments on
FOR FURTHER INFORMATION CONTACT: the reporting and recordkeeping
Karen Nelson, Office of Management requirements associated with the
Programs (HFA–250), Food and Drug dissemination of unapproved or new

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