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 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 VerDate Nov<24>2008 14:39 Feb 17, 2010 Jkt 220001 PO 00000 Frm 00041 Fmt 4703 Sfmt 4703 E:\FR\FM\18FEN1.SGM 18FEN1 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
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