Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Guidance for Humanitarian Device Exemption Holders, Institutional Review Boards, Clinical Investigators, and Food and Drug Administration Staff: Humanitarian Device Exemption Regulation: Questions and Answers; Availability, 7270-7272 [2010-3030]
Download as PDF
<![CDATA[
7270
Federal Register / Vol. 75, No. 32 / Thursday, February 18, 2010 / Notices
2009, and include the ingredients added
as of the date of submission. Section
904(c) of the act also requires
submission of information whenever
additives, or the quantities of additives,
are changed.
FDA issued guidance documents on
both (1) Registration and Product Listing
for Owners and Operators of Domestic
Tobacco Product Establishments
(November 12, 2009, 74 FR 58298) and
(2) Listing of Ingredients in Tobacco
Products (December 1, 2009, 74 FR
62795) to assist persons making such
submissions to FDA under the Tobacco
Control Act. While electronic
submission of registration and product
listing information and ingredient
listing information are not required,
FDA is strongly encouraging electronic
submission to facilitate efficiency and
timeliness of data management and
collection. To that end, FDA designed
the eSubmitter application to streamline
the data entry process for registration
and product listing and for ingredient
listing. This tool allows for importation
of large quantities of structured data,
attachments of files (e.g., in portable
document format (PDFs) and certain
media files), and automatic
acknowledgement of FDA’s receipt of
submissions. FDA also developed paper
forms (FDA Form 3742—Registration
and Listing for Owners and Operators of
Domestic Tobacco Product
Establishments and FDA Form 3743—
Listing of Ingredients in Tobacco
Products) as an alternative submission
tool. Both the eSubmitter application
and the paper forms can be accessed at
https://www.fda.gov/tobacco.
On September 1, 2009 (74 FR 45219),
FDA published notice in the Federal
Register announcing that a proposed
collection of information had been
submitted to OMB for emergency
processing under the Paperwork
Reduction Act of 1995. On September
15, 2009 (74 FR 47257), FDA published
a notice correcting the length of the
comment period, keeping it open until
October 1, 2009. On October 13, 2009
(74 FR 52495), FDA published a notice
reopening the comment period until
October 26, 2009. Based on comments
indicating that the burden estimates
were too low, FDA has adjusted its
original burden estimates. FDA has
adjusted its burden estimate for
registration and product listing for
owners and operators of domestic
establishments under section 905 of the
act from 0.75 hours per response to 3.75
hours per response. FDA has adjusted
its burden estimate for listing of
ingredients under section 904 of the act
from 0.75 hours per response to 3.0
hours per response. FDA also decreased
the number of respondents for listing of
ingredients under section 904 from
100,000 to 11,000 in response to
comments that this estimate was too
high. FDA also added the activity of
applying for a Dun and Bradstreet D-UN-S number to the burden of this
information collection for those who
chose to use eSubmitter.
FDA estimates the burden of this
collection of information as follows:
TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1
Activity
No. of
Respondents
Registration and Product
Listing for Owners and
Operators of Domestic
Establishments
Annual Frequency
per Response
Total Annual
Respondents
Hours per
Response
Total Hours
100,000
1
100,000
3.75
375,000
Listing of Ingredients
11,000
1
11,000
3.0
33,000
Obtaining a Dun and
Bradstreet D-U-N-S
Number
1,550
1
1,550
0.5
775
Total
1 There
112,550
408,775
are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: February 4, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010–3031 Filed 2–17–10; 8:45 am]
BILLING CODE 4160–01–S
WReier-Aviles on DSKGBLS3C1PROD with NOTICES
112,550
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2008–D–0434]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Guidance for
Humanitarian Device Exemption
Holders, Institutional Review Boards,
Clinical Investigators, and Food and
Drug Administration Staff:
Humanitarian Device Exemption
Regulation: Questions and Answers;
Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
VerDate Nov<24>2008
14:39 Feb 17, 2010
Jkt 220001
PO 00000
Notice.
Frm 00040
Fmt 4703
Sfmt 4703
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 March 22,
2010.
ADDRESSES: To ensure that comments on
the information collection are received,
OMB recommends that written
comments be faxed to the Office of
Information and Regulatory Affairs,
OMB, Attn: FDA Desk Officer, FAX:
202–395–7285, or e-mailed to
oira_submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910–NEW and
title Guidance for Humanitarian Device
Exemption Holders, Institutional
E:\FR\FM\18FEN1.SGM
18FEN1
Federal Register / Vol. 75, No. 32 / Thursday, February 18, 2010 / Notices
Review Boards, Clinical Investigators,
and Food and Drug Administration
Staff: Humanitarian Device Exemption
Regulation: Questions and Answers;
Availability. Also include the FDA
docket number found in brackets in the
heading of this document.
FOR FURTHER INFORMATION CONTACT:
Denver Presley Jr., Office of Information
Management, Food and Drug
Administration, 1350 Piccard Dr., P150–
400B, Rockville, MD 20850, 301–796–
3793.
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.
Guidance for Humanitarian Device
Exemption Holders, Institutional
Review Boards , Clinical Investigators,
and Food and Drug Administration
Staff: Humanitarian Device Exemption
Regulation: Questions and Answers
(OMB Control Number 0910–NEW)—
Extension
Title III of the Food and Drug
Administration Amendments Act of
2007 (FDAAA) (Public Law 110–85)
amended chapter V of the Federal Food,
Drug, and Cosmetic Act (the act) (21
U.S.C. 351 et seq.) by inserting section
515A, Pediatric Uses of Devices (21
U.S.C. 360e–1).
This new provision requires that new
applications under section 520(m) of the
act (21 U.S.C. 360j(m)) include both a
description of any pediatric
subpopulation that suffer from: (1) A
disease or condition that the device is
intended to treat, diagnose, or cure and
(2) the number of affected pediatric
patients.
Title III of FDAAA also amended
section 520(m) of the act as follows:
Section 520(m)(6)(A)(ii) provides that
the Secretary of Health and Human
Services will assign an annual
distribution number (ADN) for devices
indicated for use in a pediatric
population or in a pediatric
subpopulation. The ADN shall be based
on the following information in a
humanitarian device exemption (HDE)
application: (1) The number of
individuals affected by the disease or
condition that such device is intended
to treat, diagnose, or cure and of that
number; (2) the number of individuals
likely to use the device and (3) the
number of devices reasonably necessary
to treat such individuals.
Section 520(m)(6)(A)(iii) provides that
an HDE holder immediately notify the
agency if the number of devices
distributed during any calendar year
exceeds the ADN.
Section 520(m)(6)(C) provides that an
HDE holder may petition to modify the
ADN if additional information on the
number of individuals affected by the
disease or condition arises.
In the Federal Register of August 5,
2008 (73 FR 45460), FDA published a
60-day notice requesting public
comment on the proposed collection of
information. FDA had previously
published a 30-day notice on September
30, 2009 (74 FR 50214) and is
republishing this 30-day notice to
provide a more descriptive response to
the comments received in response to
the August 5, 2008, notice.
FDA received 7 letters in response to
the August 5, 2008, notice. Six of the
seven comments were substantive, each
containing several comments regarding
many of the 66 questions contained in
the guidance. The comments and the
agency’s responses are discussed in the
following paragraphs:
(Comment) Several of the comments
sought clarification regarding when the
Annual Distribution Number (ADN)
reporting requirement applied.
(Response) A paragraph was added to
clarify that the ADN relates only to
those devices that are on the market
through the HDE process for a disease
or condition that occurs in pediatric
patients or in a pediatric subpopulation.
The response to Question 27 was
augmented to include the phrase
‘‘independent Institutional Review
Board (IRB)’’ to clarify that not all IRBs
are internal bodies within a hospital or
clinic.
(Comment) Question 31 was
augmented to describe the different
reporting requirements for
manufacturers and for user facilities.
(Response) Manufacturers must
submit reports to FDA and the ‘‘IRB of
record’’ whenever a humanitarian use
7271
device (HUD) may have caused or
contributed to a death or serious injury,
or has malfunctioned and would be
likely to cause or contribute to a death
or serious injury if the malfunction were
to recur (§§ 803.50 and 814.126(a) (21
CFR 803.50 and 814.126(a))). User
facilities must submit reports to FDA,
the ‘‘IRB of record’’ and the
manufacturer whenever a HUD may
have caused or contributed to a death.
They must also submit reports to FDA
and the ‘‘IRB of record’’ if the
manufacturer is unknown, whenever a
HUD may have caused or contributed to
a serious injury (§§ 803.30 and
814.126(a)).
(Comment) Some of the comments
related to the placement of information
in the draft guidance.
(Response) In Question 40, the
statement: ‘‘If a HUD is being
investigated in an Investigational Device
Exemption, (IDE) Study for a different
indication, does it impact the number of
allowable patients under the HDE’’ was
redesignated as question 35 and moved
from the ‘‘IRB Section’’ of the guidance
and placed in the section, ‘‘After FDA
Approves an HDE’’ because it did not
pertain directly to IRBs.
(Comment) Changes were made to the
section, ‘‘The Role of Institutional
Review Boards (IRBs),’’ question 37
specifically, in order to clarify the
distinction between the terms ‘‘use,’’
‘‘HUD,’’ and ‘‘investigational use/clinical
investigation’’ of a HUD.
(Response) Specifically, FDA clarified
that the term ‘‘use’’ in the guidance,
when unmodified, refers to the use of a
HUD according to its approved labeling
and indication(s). If a HUD is being used
in a clinical investigation (i.e.,
collection of safety and effectiveness
data), whether for its HDE-approved
indications or for a different indication,
then this document refers to
‘‘investigational use’’ or ‘‘clinical
investigation’’ of the HUD. Finally in
addition to adding clarifying
information, a decision tree was also
added to the guidance for ease of
reference for IRBs.
FDA estimates the burden of this
collection of information as follows:
WReier-Aviles on DSKGBLS3C1PROD with NOTICES
TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1
Section of the Federal
Food, Drug,
and Cosmetic Act
No. of
Respondents
Annual Frequency
per Response
Total Annual
Respondents
Hours per
Response
Total Hours
515A(a)(2)
5
1
5
100
500
520(m)(6)(A)(ii)
3
1
3
50
150
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14:39 Feb 17, 2010
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Fmt 4703
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E:\FR\FM\18FEN1.SGM
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7272
Federal Register / Vol. 75, No. 32 / Thursday, February 18, 2010 / Notices
TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1—Continued
Section of the Federal
Food, Drug,
and Cosmetic Act
No. of
Respondents
Annual Frequency
per Response
Total Annual
Respondents
Hours per
Response
Total Hours
520(m)(6)(A)(iii)
1
1
1
100
100
520(m)(6)(C)
5
1
5
100
500
Total
WReier-Aviles on DSKGBLS3C1PROD with NOTICES
1 There
1,250
are no capital costs or operating and maintenance costs associated with this collection of information.
FDA based these estimates on the
number of original HDE applications
that the Center for Devices and
Radiological Health (CDRH) received for
the period October 1, 2004, through
September 30, 2007. During that time,
CDRH received 16 original HDE
applications or about 5 per year.
FDA estimates that for each year,
CDRH will receive five HDE
applications and that three of these
applications will be indicated for
pediatric use. One HDE holder will
notify the agency that the number of
devices distributed in the year has
exceeded the ADN and five HDE holders
will petition to have the ADN modified
due to additional information on the
number of individuals affected by the
disease of condition.
The draft guidance refers also to
previously approved collections of
information found in FDA regulations.
The collections of information in 21
CFR part 803 have been approved under
OMB control number 0910–0437; the
collections of information in 21 CFR
part 812 have been approved under
OMB control number 0910–0078; the
collections of information in 21 CFR
part 807, subpart E, have been approved
under OMB control number 0910–0120;
the collections of information in 21 CFR
part 814, subparts A, B, and C, have
been approved under OMB control
number 0910–0231; the collection of
information in 21 CFR parts 50 and 56
have been approved under OMB control
number 0910–0130; the collections of
information in 21 CFR part 820 have
been approved under OMB control
number 0910–0073; the collections of
information in 21 CFR part 814, subpart
H, have been approved under OMB
control number 0910–0332; and the
collection of information requirements
in 21 CFR 10.30 have been approved
under OMB control number 0910–0183.
Dated: February 4, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010–3030 Filed 2–17–10; 8:45 am]
BILLING CODE 4160–01–S
VerDate Nov<24>2008
14:39 Feb 17, 2010
Jkt 220001
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2009–N–0512]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Antimicrobial
Animal Drug Distribution Reports
Under Section 105 of the Animal Drug
User Fee Amendments of 2008
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 March 22,
2010.
ADDRESSES: To ensure that comments on
the information collection are received,
OMB recommends that written
comments be faxed to the Office of
Information and Regulatory Affairs,
OMB, Attn: FDA Desk Officer, FAX:
202–395–7285, or e-mailed to
oira_submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910—NEW and
title ‘‘Antimicrobial Animal Drug
Distribution Reports Under Section 105
of the Animal Drug User Fee
Amendments of 2008.’’ Also include the
FDA docket number found in brackets
in the heading of this document.
FOR FURTHER INFORMATION CONTACT:
Denver Presley Jr., Office of Information
Management, Food and Drug
Administration, 1350 Piccard Dr., PI50–
400B, Rockville, MD 20850, 301–796–
3793.
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.
PO 00000
Frm 00042
Fmt 4703
Sfmt 4703
Antimicrobial Animal Drug
Distribution Reports Under Section 105
of the Animal Drug User Fee
Amendments of 2008—(OMB Control
Number 0910–NEW)—Extension
Section 105 of the Animal Drug User
Fee Amendments of 2008 (ADUFA)
amended section 512 of the Federal
Food, Drug, and Cosmetic Act (the act)
(21 U.S.C. 360b) to require that the
sponsor of each new animal drug that
contains an antimicrobial agent submit
an annual report to FDA on the amount
of each antimicrobial active ingredient
in the drug that is sold or distributed for
use in food-producing animals,
including information on any
distributor-labeled product. The
legislation was enacted to address the
problem of antimicrobial resistance, and
to help ensure that FDA has the
necessary information to examine safety
concerns related to the use of antibiotics
in food-producing animals (154
Congressional Record H7534).
Each report must specify: (1) The
amount of each antimicrobial active
ingredient by container size, strength,
and dosage form; (2) quantities
distributed domestically and quantities
exported; and (3) a listing of the target
animals, indications, and production
classes that are specified on the
approved label of the product.
The first report must be submitted not
later than March 31, 2010. The report
must cover the period of the preceding
calendar year and include separate
information for each month of the
calendar year. The reports required
under section 105 of ADUFA are
required to be separate from periodic
drug experience reports that are
required under § 514.80(b)(4) (21 CFR
§ 514.80(b)(4) (OMB Control No. 0910–
0284).
In the Federal Register of October 26,
2009 (74FR 55046), FDA published a 60day notice requesting public comment
on the proposed collection of
information. FDA received comments
from two organizations. Both
commenters supported the information
collection and stated that the data to be
collected would be useful in addressing
E:\FR\FM\18FEN1.SGM
18FEN1
]]>Agencies
[Federal Register Volume 75, Number 32 (Thursday, February 18, 2010)]
[Notices]
[Pages 7270-7272]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-3030]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2008-D-0434]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Guidance for
Humanitarian Device Exemption Holders, Institutional Review Boards,
Clinical Investigators, and Food and Drug Administration Staff:
Humanitarian Device Exemption Regulation: Questions and Answers;
Availability
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 March
22, 2010.
ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be faxed to the Office
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer,
FAX: 202-395-7285, or e-mailed to oira_submission@omb.eop.gov. All
comments should be identified with the OMB control number 0910-NEW and
title Guidance for Humanitarian Device Exemption Holders, Institutional
[[Page 7271]]
Review Boards, Clinical Investigators, and Food and Drug Administration
Staff: Humanitarian Device Exemption Regulation: Questions and Answers;
Availability. Also include the FDA docket number found in brackets in
the heading of this document.
FOR FURTHER INFORMATION CONTACT: Denver Presley Jr., Office of
Information Management, Food and Drug Administration, 1350 Piccard Dr.,
P150-400B, Rockville, MD 20850, 301-796-3793.
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.
Guidance for Humanitarian Device Exemption Holders, Institutional
Review Boards , Clinical Investigators, and Food and Drug
Administration Staff: Humanitarian Device Exemption Regulation:
Questions and Answers (OMB Control Number 0910-NEW)--Extension
Title III of the Food and Drug Administration Amendments Act of
2007 (FDAAA) (Public Law 110-85) amended chapter V of the Federal Food,
Drug, and Cosmetic Act (the act) (21 U.S.C. 351 et seq.) by inserting
section 515A, Pediatric Uses of Devices (21 U.S.C. 360e-1).
This new provision requires that new applications under section
520(m) of the act (21 U.S.C. 360j(m)) include both a description of any
pediatric subpopulation that suffer from: (1) A disease or condition
that the device is intended to treat, diagnose, or cure and (2) the
number of affected pediatric patients.
Title III of FDAAA also amended section 520(m) of the act as
follows:
Section 520(m)(6)(A)(ii) provides that the Secretary of Health and
Human Services will assign an annual distribution number (ADN) for
devices indicated for use in a pediatric population or in a pediatric
subpopulation. The ADN shall be based on the following information in a
humanitarian device exemption (HDE) application: (1) The number of
individuals affected by the disease or condition that such device is
intended to treat, diagnose, or cure and of that number; (2) the number
of individuals likely to use the device and (3) the number of devices
reasonably necessary to treat such individuals.
Section 520(m)(6)(A)(iii) provides that an HDE holder immediately
notify the agency if the number of devices distributed during any
calendar year exceeds the ADN.
Section 520(m)(6)(C) provides that an HDE holder may petition to
modify the ADN if additional information on the number of individuals
affected by the disease or condition arises.
In the Federal Register of August 5, 2008 (73 FR 45460), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. FDA had previously published a 30-day notice
on September 30, 2009 (74 FR 50214) and is republishing this 30-day
notice to provide a more descriptive response to the comments received
in response to the August 5, 2008, notice.
FDA received 7 letters in response to the August 5, 2008, notice.
Six of the seven comments were substantive, each containing several
comments regarding many of the 66 questions contained in the guidance.
The comments and the agency's responses are discussed in the following
paragraphs:
(Comment) Several of the comments sought clarification regarding
when the Annual Distribution Number (ADN) reporting requirement
applied.
(Response) A paragraph was added to clarify that the ADN relates
only to those devices that are on the market through the HDE process
for a disease or condition that occurs in pediatric patients or in a
pediatric subpopulation. The response to Question 27 was augmented to
include the phrase ``independent Institutional Review Board (IRB)'' to
clarify that not all IRBs are internal bodies within a hospital or
clinic.
(Comment) Question 31 was augmented to describe the different
reporting requirements for manufacturers and for user facilities.
(Response) Manufacturers must submit reports to FDA and the ``IRB
of record'' whenever a humanitarian use device (HUD) may have caused or
contributed to a death or serious injury, or has malfunctioned and
would be likely to cause or contribute to a death or serious injury if
the malfunction were to recur (Sec. Sec. 803.50 and 814.126(a) (21 CFR
803.50 and 814.126(a))). User facilities must submit reports to FDA,
the ``IRB of record'' and the manufacturer whenever a HUD may have
caused or contributed to a death. They must also submit reports to FDA
and the ``IRB of record'' if the manufacturer is unknown, whenever a
HUD may have caused or contributed to a serious injury (Sec. Sec.
803.30 and 814.126(a)).
(Comment) Some of the comments related to the placement of
information in the draft guidance.
(Response) In Question 40, the statement: ``If a HUD is being
investigated in an Investigational Device Exemption, (IDE) Study for a
different indication, does it impact the number of allowable patients
under the HDE'' was redesignated as question 35 and moved from the
``IRB Section'' of the guidance and placed in the section, ``After FDA
Approves an HDE'' because it did not pertain directly to IRBs.
(Comment) Changes were made to the section, ``The Role of
Institutional Review Boards (IRBs),'' question 37 specifically, in
order to clarify the distinction between the terms ``use,'' ``HUD,''
and ``investigational use/clinical investigation'' of a HUD.
(Response) Specifically, FDA clarified that the term ``use'' in the
guidance, when unmodified, refers to the use of a HUD according to its
approved labeling and indication(s). If a HUD is being used in a
clinical investigation (i.e., collection of safety and effectiveness
data), whether for its HDE-approved indications or for a different
indication, then this document refers to ``investigational use'' or
``clinical investigation'' of the HUD. Finally in addition to adding
clarifying information, a decision tree was also added to the guidance
for ease of reference for IRBs.
FDA estimates the burden of this collection of information as
follows:
Table 1.--Estimated Annual Reporting Burden\1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Section of the Federal Food, Drug, and No. of Annual Frequency Total Annual
Cosmetic Act Respondents per Response Respondents Hours per Response Total Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
515A(a)(2) 5 1 5 100 500
--------------------------------------------------------------------------------------------------------------------------------------------------------
520(m)(6)(A)(ii) 3 1 3 50 150
--------------------------------------------------------------------------------------------------------------------------------------------------------
[[Page 7272]]
520(m)(6)(A)(iii) 1 1 1 100 100
--------------------------------------------------------------------------------------------------------------------------------------------------------
520(m)(6)(C) 5 1 5 100 500
--------------------------------------------------------------------------------------------------------------------------------------------------------
Total 1,250
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
FDA based these estimates on the number of original HDE
applications that the Center for Devices and Radiological Health (CDRH)
received for the period October 1, 2004, through September 30, 2007.
During that time, CDRH received 16 original HDE applications or about 5
per year.
FDA estimates that for each year, CDRH will receive five HDE
applications and that three of these applications will be indicated for
pediatric use. One HDE holder will notify the agency that the number of
devices distributed in the year has exceeded the ADN and five HDE
holders will petition to have the ADN modified due to additional
information on the number of individuals affected by the disease of
condition.
The draft guidance refers also to previously approved collections
of information found in FDA regulations. The collections of information
in 21 CFR part 803 have been approved under OMB control number 0910-
0437; the collections of information in 21 CFR part 812 have been
approved under OMB control number 0910-0078; the collections of
information in 21 CFR part 807, subpart E, have been approved under OMB
control number 0910-0120; the collections of information in 21 CFR part
814, subparts A, B, and C, have been approved under OMB control number
0910-0231; the collection of information in 21 CFR parts 50 and 56 have
been approved under OMB control number 0910-0130; the collections of
information in 21 CFR part 820 have been approved under OMB control
number 0910-0073; the collections of information in 21 CFR part 814,
subpart H, have been approved under OMB control number 0910-0332; and
the collection of information requirements in 21 CFR 10.30 have been
approved under OMB control number 0910-0183.
Dated: February 4, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-3030 Filed 2-17-10; 8:45 am]
BILLING CODE 4160-01-S
