Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Medical Devices: Humanitarian Use Devices, 82301-82302 [2011-33551]

Download as PDF Federal Register / Vol. 76, No. 251 / Friday, December 30, 2011 / Notices Information Management, Food and Drug Administration, 1350 Piccard Dr., PI50–400B, Rockville, MD 20850, (301) 796–7651, Juanmanuel.vilela@fda.hhs.gov. Under the PRA (44 U.S.C. 3501–3520), Federal agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. ‘‘Collection of information’’ is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes Agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal agencies to provide a 60-day notice in the Federal Register concerning each proposed collection of information before submitting the collection to OMB for approval. To comply with this requirement, FDA is publishing notice of the proposed collection of information set forth in this document. With respect to the following collection of information, FDA invites comments on these topics: (1) Whether the proposed collection of information is necessary for the proper performance of FDA’s functions, including whether the information will have practical utility; (2) the accuracy of FDA’s estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology. This document solicits comments on certain labeling requirements for blood and blood components, including Source Plasma, finalized as part of a rule FDA is publishing elsewhere in this Federal Register entitled ‘‘Revisions to Labeling Requirements for Blood and Blood Components, Including Source Plasma.’’ SUPPLEMENTARY INFORMATION: srobinson on DSK4SPTVN1PROD with NOTICES Revisions to Labeling Requirements for Blood and Blood Components, Including Source Plasma—(OMB Control Number 0910–NEW) FDA is finalizing the labeling requirements for blood or blood components intended for use in transfusion or for further manufacture pursuant to the provisions of the Public Health Service Act (PHS Act) (42 U.S.C. 262–264), and the drugs, devices, and general administrative provisions of the VerDate Mar<15>2010 19:02 Dec 29, 2011 Jkt 226001 Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321, 331, 351–353, 355, 360, 360j, 371, and 374). Under these provisions of the PHS Act and the Federal Food, Drug, and Cosmetic Act, we have the authority to issue and enforce regulations designed to ensure that biological products are safe, pure, potent, and properly labeled, and to prevent the introduction, transmission, and spread of communicable disease. Under this rulemaking, FDA is consolidating the regulations related to labeling blood and blood components. Regulations for labeling of blood and blood components will be consolidated into § 606.121 (Container label) (21 CFR 606.121) and 21 CFR 606.122 (Circular of information). This notice solicits comments on the information collection associated with § 606.121(c)(11) (21 CFR 606.121(c)(11)) which requires that if the product is intended for further manufacturing use, a statement listing the results of all the tests for communicable disease agents required under § 610.40 (21 CFR 610.40) for which the donation has been tested and found negative must be on the container label; except that the label for Source Plasma is not required to list the negative results of serological syphilis testing under § 610.40(i) (21 CFR 610.40(i)) and § 640.65(b) (21 CFR 640.65(b)). In addition, this notice also solicits comments on the information collection associated with § 606.121(e)(2)(i) (21 CFR 606.121(e)(2)(i)) which requires that the product labels of certain red blood cells must include the type of additive solution with which the product was prepared. The Agency believes the rule amendments and the information collection provisions under § 606.121(c)(11) and § 606.121(e)(2)(i) in the final rule are part of usual and customary business practice and do not create any new burden for respondent. The collection of information requirements under §§ 606.121 and 606.122 are approved under OMB control number 0910–0116; and those in 21 CFR 640.70 have been approved under OMB control number 0910–0338. Under 5 CFR 1320.3(b)(2), the time, effort, and financial resources necessary to comply with a collection of information are excluded from the burden estimate if the reporting, recordkeeping, or disclosure activities needed to comply are usual and customary because they would occur in the normal course of activities. PO 00000 Frm 00034 Fmt 4703 Sfmt 4703 82301 Dated: December 22, 2011. Leslie Kux, Acting Assistant Commissioner for Policy. [FR Doc. 2011–33555 Filed 12–29–11; 8:45 am] BILLING CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2011–N–0619] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Medical Devices: Humanitarian Use Devices AGENCY: Food and Drug Administration, HHS. ACTION: Notice. 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 January 30, 2012. 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 emailed to oira_submission@omb.eop.gov. All comments should be identified with the OMB control number 0910–0332. Also include the FDA docket number found in brackets in the heading of this document. SUMMARY: FOR FURTHER INFORMATION CONTACT: Daniel Gittleson, Office of Information Management, Food and Drug Administration, 1350 Piccard Dr., PI50– 400B, Rockville, MD 20850, (301) 796– 5156, Daniel.Gittleson@fda.hhs.gov. 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. Medical Devices: Humanitarian Use Devices—(OMB Control Number 0910– 0332)—Extension This collection of information implements the humanitarian use device (HUD) provision of section 520(m) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 360j(m)) and subpart H, part 814 (21 CFR part 814). Under section 520(m) of E:\FR\FM\30DEN1.SGM 30DEN1 82302 Federal Register / Vol. 76, No. 251 / Friday, December 30, 2011 / Notices the FD&C Act, FDA is authorized to exempt an HUD from the effectiveness requirements of sections 514 and 515 of the FD&C Act (21 U.S.C. 360d and 360e) provided that the device: (1) Is used to treat or diagnose a disease or condition that affects fewer than 4,000 individuals in the United States; (2) would not be available to a person with such a disease or condition unless an exemption is granted because there is no comparable device other than another HUD approved under this exemption that is available to treat or diagnose the disease or condition; and (3) will not expose patients to an unreasonable or significant risk of illness or injury with the probable benefit to health from using the device outweighing the risk of injury or illness from its use. This takes into account the probable risks and benefits of currently available devices or alternative forms of treatment. The information collected will assist FDA in making determinations on the following: (1) Whether to grant HUD designation of a medical device; (2) exempt an HUD from the effectiveness requirements under sections 514 and 515 of the FD&C Act, provided that the device meets requirements set forth under section 520(m) of the FD&C Act; and (3) whether to grant marketing approval(s) for the HUD. Failure to collect this information would prevent FDA from making a determination on the factors listed previously in this document. Further, the collected information would also enable FDA to determine whether the holder of an HUD is in compliance with the HUD provisions under section 520(m) of the FD&C Act. The number of respondents in tables 1 and 2 of this document are an average from data for the previous 3 years, i.e., fiscal years 2008 to 2010. The number of annual reports submitted under section 814.126(b)(1) in table 1 reflects 43 respondents with approved HUD applications. Likewise, under section 814.126(b)(2) in table 2, the number of recordkeepers is 43. In the Federal Register of September 7, 2011 (76 FR 55394), FDA published a 60-day notice requesting public comment on the proposed collection of information. No comments were received. FDA estimates the burden of this collection of information as follows: TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1 Number of respondents 21 CFR Section Number of responses per respondent Total annual responses Average burden per response Total hours 814.102 ................................................................................ 814.104 ................................................................................ 814.106 ................................................................................ 814.108 ................................................................................ 814.116(e)(3) ....................................................................... 814.124(a) ............................................................................ 814.124(b) ............................................................................ 814.126(b)(1) ....................................................................... 17 5 5 47 3 22 12 43 1 1 5 1 1 1 1 1 17 5 25 47 3 22 12 43 40 320 50 80 1 1 2 120 680 1,600 1,250 3,760 3 22 24 5,160 Total .............................................................................. ........................ ........................ ........................ ........................ 12,499 1 There are no capital costs or operating and maintenance costs associated with this collection of information. TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1 Number of recordkeeper 21 CFR Section 814.126(b)(2) ....................................................................... 1 There 43 Total annual records 1 43 Average burden per recordkeeping 2 Total hours 86 are no capital costs or operating and maintenance costs associated with this collection of information. Dated: December 27, 2011. Leslie Kux, Acting Assistant Commissioner for Policy. [FR Doc. 2011–33551 Filed 12–29–11; 8:45 am] DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2008–P–0555] BILLING CODE 4160–01–P srobinson on DSK4SPTVN1PROD with NOTICES Number of records per recordkeeper Determination That HYCODAN (Hydrocodone Bitartrate and Homatropine Methylbromide) Tablets, 5 Milligrams/1.5 Milligrams, and HYCODAN (Hydrocodone Bitartrate and Homatropine Methylbromide) Oral Solution, 5 Milligrams/5 Milliliters and 1.5 Milligrams/5 Milliliters, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness AGENCY: Food and Drug Administration, HHS. ACTION: VerDate Mar<15>2010 19:02 Dec 29, 2011 Jkt 226001 PO 00000 Notice. Frm 00035 Fmt 4703 Sfmt 4703 The Food and Drug Administration (FDA) has determined that HYCODAN (hydrocodone bitartrate and homatropine methylbromide) tablets, 5 milligrams (mg)/1.5 mg, and HYCODAN (hydrocodone bitartrate and homatropine methylbromide) oral solution, 5 mg/5 milliliters (mL) and 1.5 mg/5 mL, were not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for hydrocodone bitartrate and homatropine methylbromide tablets, 5 mg/1.5 mg, and HYCODAN (hydrocodone bitartrate and homatropine methylbromide) oral solution, 5 mg/5 mL and 1.5 mg/5 mL, if all other legal and regulatory requirements are met. SUMMARY: E:\FR\FM\30DEN1.SGM 30DEN1

Agencies

[Federal Register Volume 76, Number 251 (Friday, December 30, 2011)]
[Notices]
[Pages 82301-82302]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-33551]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0619]


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Medical Devices: 
Humanitarian Use Devices

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 January 
30, 2012.

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 emailed to oira_submission@omb.eop.gov. All 
comments should be identified with the OMB control number 0910-0332. 
Also include the FDA docket number found in brackets in the heading of 
this document.

FOR FURTHER INFORMATION CONTACT: Daniel Gittleson, Office of 
Information Management, Food and Drug Administration, 1350 Piccard Dr., 
PI50-400B, Rockville, MD 20850, (301) 796-5156, 
Daniel.Gittleson@fda.hhs.gov.

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.

Medical Devices: Humanitarian Use Devices--(OMB Control Number 0910-
0332)--Extension

    This collection of information implements the humanitarian use 
device (HUD) provision of section 520(m) of the Federal Food, Drug, and 
Cosmetic Act (the FD&C Act) (21 U.S.C. 360j(m)) and subpart H, part 814 
(21 CFR part 814). Under section 520(m) of

[[Page 82302]]

the FD&C Act, FDA is authorized to exempt an HUD from the effectiveness 
requirements of sections 514 and 515 of the FD&C Act (21 U.S.C. 360d 
and 360e) provided that the device: (1) Is used to treat or diagnose a 
disease or condition that affects fewer than 4,000 individuals in the 
United States; (2) would not be available to a person with such a 
disease or condition unless an exemption is granted because there is no 
comparable device other than another HUD approved under this exemption 
that is available to treat or diagnose the disease or condition; and 
(3) will not expose patients to an unreasonable or significant risk of 
illness or injury with the probable benefit to health from using the 
device outweighing the risk of injury or illness from its use. This 
takes into account the probable risks and benefits of currently 
available devices or alternative forms of treatment.
    The information collected will assist FDA in making determinations 
on the following: (1) Whether to grant HUD designation of a medical 
device; (2) exempt an HUD from the effectiveness requirements under 
sections 514 and 515 of the FD&C Act, provided that the device meets 
requirements set forth under section 520(m) of the FD&C Act; and (3) 
whether to grant marketing approval(s) for the HUD. Failure to collect 
this information would prevent FDA from making a determination on the 
factors listed previously in this document. Further, the collected 
information would also enable FDA to determine whether the holder of an 
HUD is in compliance with the HUD provisions under section 520(m) of 
the FD&C Act.
    The number of respondents in tables 1 and 2 of this document are an 
average from data for the previous 3 years, i.e., fiscal years 2008 to 
2010. The number of annual reports submitted under section 
814.126(b)(1) in table 1 reflects 43 respondents with approved HUD 
applications. Likewise, under section 814.126(b)(2) in table 2, the 
number of recordkeepers is 43.
    In the Federal Register of September 7, 2011 (76 FR 55394), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. No comments were received.
    FDA estimates the burden of this collection of information as 
follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                     Number of
         21 CFR Section              Number of     responses per   Total annual   Average burden    Total hours
                                    respondents     respondent       responses     per response
----------------------------------------------------------------------------------------------------------------
814.102.........................              17               1              17              40             680
814.104.........................               5               1               5             320           1,600
814.106.........................               5               5              25              50           1,250
814.108.........................              47               1              47              80           3,760
814.116(e)(3)...................               3               1               3               1               3
814.124(a)......................              22               1              22               1              22
814.124(b)......................              12               1              12               2              24
814.126(b)(1)...................              43               1              43             120           5,160
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............          12,499
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.


                               Table 2--Estimated Annual Recordkeeping Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                     Number of                    Average burden
         21 CFR Section              Number of      records per    Total annual         per         Total hours
                                   recordkeeper    recordkeeper       records      recordkeeping
----------------------------------------------------------------------------------------------------------------
814.126(b)(2)...................              43               1              43               2              86
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.


    Dated: December 27, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-33551 Filed 12-29-11; 8:45 am]
BILLING CODE 4160-01-P
This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.