81 FR 30312 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Information To Accompany Humanitarian Device Exemption Applications and Annual Distribution Number Reporting Requirements
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 81, Issue 94 (May 16, 2016)
Food and Drug Administration
Federal Register Volume 81, Issue 94 (May 16, 2016)
| Page Range | 30312-30314 | |
| FR Document | 2016-11532 |
[Federal Register Volume 81, Number 94 (Monday, May 16, 2016)] [Notices] [Pages 30312-30314] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-11532] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-1203] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Information To Accompany Humanitarian Device Exemption Applications and Annual Distribution Number Reporting Requirements AGENCY: Food and Drug Administration, HHS. [[Page 30313]] 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 June 15, 2016. 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 [email protected]. All comments should be identified with the OMB control number 0910-0661. Also include the FDA docket number found in brackets in the heading of this document. FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations, Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver Spring, MD 20993-0002, [email protected]. 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. Information To Accompany Humanitarian Device Exemption Applications and Annual Distribution Number Reporting Requirements OMB Control Number 0910-0661--Extension Under section 520(m) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 360j(m)), FDA is authorized to exempt a humanitarian use device (HUD) from the effectiveness requirements in 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 the exemption is granted, and there is no comparable device, other than another HUD approved under this exemption, available to treat or diagnose the disease or condition; (3) the device will not expose patients to an unreasonable or significant risk of illness or injury; and (4) the probable benefit to health from using the device outweighs the risk of injury or illness from its use, taking into account the probable risks and benefits of currently available devices or alternative forms of treatment. HUDs approved under an HDE cannot be sold for an amount that exceeds the costs of research and development, fabrication, and distribution of the device (i.e., for profit), except in narrow circumstances. Section 613 of the Food and Drug Administration Safety and Innovation Act (FDASIA) (Pub. L. 112-144), signed into law on July 9, 2012, amended section 520(m) of the FD&C Act. Under section 520(m)(6)(A)(i) of the FD&C Act, as amended by FDASIA, a HUD approved under an HDE is eligible to be sold for profit if the device meets the following criteria: The device is intended for the treatment or diagnosis of a disease or condition that occurs in pediatric patients or in a pediatric subpopulation, and such device is labeled for use in pediatric patients or in a pediatric subpopulation in which the disease or condition occurs; or the device is intended for the treatment or diagnosis of a disease or condition that does not occur in pediatric patients, or that occurs in pediatric patients in such numbers that the development of the device for such patients is impossible, highly impracticable, or unsafe. Section 520(m)(6)(A)(ii) of the FD&C Act, as amended by FDASIA, provides that the Secretary of Health and Human Services will assign an annual distribution number (ADN) for devices that meet the eligibility criteria to be permitted to be sold for profit. The ADN is defined as the number of devices ``reasonably needed to treat, diagnose, or cure a population of 4,000 individuals in the United States'', and therefore shall be based on the following information in a HDE application: The number of devices reasonably necessary to treat such individuals. Section 520(m)(6)(A)(iii) of the FD&C Act (http://www.fda.gov/RegulatoryInformation/Legislation/FederalFoodDrugandCosmeticActFDCAct/FDCActChapterVDrugsandDevices/default.htm) 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) of the FD&C Act provides that an HDE holder may petition to modify the ADN if additional information arises. On August 5, 2008, FDA issued a guidance entitled ``Guidance for HDE Holders, Institutional Review Boards (IRBs), Clinical Investigators, and Food and Drug Administration Staff--Humanitarian Device Exemption (HDE) Regulation: Questions and Answers'' (http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm110203.pdf). The guidance was developed and issued prior to the enactment of FDASIA, and certain sections of this guidance may no longer be current as a result of FDASIA. In the Federal Register of March 18, 2014 (79 FR 15130), FDA announced the availability of the draft guidance entitled ``Humanitarian Device Exemption: Questions and Answers; Draft Guidance for Humanitarian Device Exemption Holders, Institutional Review Boards, Clinical Investigators, and Food and Drug Administration Staff'', that when finalized, will represent FDA's current thinking on this topic. FDA is requesting the extension of OMB approval for the collection of information required under the statutory mandate of sections 515A (21 U.S.C. 360e-1) and 520(m) of the FD&C Act as amended. In the Federal Register of January 15, 2016 (81 FR 2220), FDA published a 60-day notice requesting public comment on the proposed collection of information. Two comments were received. One comment was outside of the scope of the four information collection-related topics on which the notice solicits public comment. We did not consider the other comment because it was submitted in a foreign language and was not accompanied by an English translation as required in 21 CFR 10.20(c)(2). FDA estimates the burden of this collection of information as follows: Table 1--Estimated Annual Reporting Burden \1\ ---------------------------------------------------------------------------------------------------------------- Number of Average Activity/section of FD&C Act (as Number of responses per Total annual burden per Total hours amended) or FDASIA respondents respondent responses response ---------------------------------------------------------------------------------------------------------------- Pediatric Subpopulation and 6 1 6 100 600 Patient Information--515A(a)(2) of the FD&C Act................ [[Page 30314]] Exemption from Profit 3 1 3 50 150 Prohibition Information-- 520(m)(6)(A)(i) and (ii) of the FD&C Act....................... Request for Determination of 2 1 2 10 20 Eligibility Criteria--613(b) of FDASIA......................... ADN Notification-- 1 1 1 100 100 520(m)(6)(A)(iii) of the FD&C Act............................ ADN Modification--520(m)(6)(C) 5 1 5 100 500 of the FD&C Act................ ------------------------------------------------------------------------------- Total....................... .............. .............. .............. .............. 1,370 ---------------------------------------------------------------------------------------------------------------- \1\ There are no capital costs or operating and maintenance costs associated with this collection of information. FDA's Center for Devices and Radiological Health receives an estimated average of six HDE applications per year. FDA estimates that three of these applications will be indicated for pediatric use. We estimate that we will receive approximately two requests for determination of eligibility criteria per year. FDA estimates that very few or no HDE holders will notify the Agency that the number of devices distributed in the year has exceeded the ADN. FDA estimates that five HDE holders will petition to have the ADN modified due to additional information on the number of individuals affected by the disease or condition. Dated: May 11, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016-11532 Filed 5-13-16; 8:45 am] BILLING CODE 4164-01-P
![30312 Federal Register / Vol. 81, No. 94 / Monday, May 16, 2016 / Notices
manner detailed (see ‘‘Written/Paper Docket: For access to the docket to practices regulation (21 CFR 10.115).
Submissions’’ and ‘‘Instructions’’). read background documents or the The guidance represents the current
electronic and written/paper comments thinking of FDA on postmarket
Written/Paper Submissions
received, go to http:// surveillance under section 522 of the
Submit written/paper submissions as www.regulations.gov and insert the FD&C Act. It does not establish any
follows: docket number, found in brackets in the rights for any person and is not binding
• Mail/Hand delivery/Courier (for heading of this document, into the on FDA or the public. You can use an
written/paper submissions): Division of ‘‘Search’’ box and follow the prompts alternative approach if it satisfies the
Dockets Management (HFA–305), Food and/or go to the Division of Dockets requirements of the applicable statutes
and Drug Administration, 5630 Fishers Management, 5630 Fishers Lane, Rm. and regulations.
Lane, Rm. 1061, Rockville, MD 20852. 1061, Rockville, MD 20852.
• For written/paper comments Submit written requests for single III. Electronic Access
submitted to the Division of Dockets copies of the guidance to the Office of Persons interested in obtaining a copy
Management, FDA will post your the Center Director, Guidance and of the guidance may do so by
comment, as well as any attachments, Policy Development, Center for Devices downloading an electronic copy from
except for information submitted, and Radiological Health, Food and Drug the Internet. A search capability for all
marked and identified, as confidential, Administration, 10903 New Hampshire Center for Devices and Radiological
if submitted as detailed in Ave., Bldg. 66, Rm. 5431, Silver Spring, Health guidance documents is available
‘‘Instructions.’’ MD 20993–0002. Send one self- at http://www.fda.gov/MedicalDevices/
Instructions: All submissions received addressed adhesive label to assist that DeviceRegulationandGuidance/
must include the Docket No. FDA– office in processing your request. The GuidanceDocuments/default.htm.
2011–D–0514 for ‘‘Postmarket guidance may also be obtained by mail Guidance documents are also available
Surveillance Under Section 522 of the by calling CBER at 1–800–835–4709 or at http://www.regulations.gov. Persons
Federal Food, Drug, and Cosmetic Act.’’ 240–402–8010. See the SUPPLEMENTARY unable to download an electronic copy
Received comments will be placed in INFORMATION section for information on of ‘‘Postmarket Surveillance Under
the docket and, except for those electronic access to the guidance. Section 522 of the Federal Food, Drug,
submitted as ‘‘Confidential FOR FURTHER INFORMATION CONTACT: and Cosmetic Act’’ may send an email
Submissions,’’ publicly viewable at Nicole Jones, Associate Director
http://www.regulations.gov or at the request to CDRH-Guidance@fda.hhs.gov
Program Operations, Center for Devices to receive an electronic copy of the
Division of Dockets Management and Radiological Health, Food and Drug
between 9 a.m. and 4 p.m., Monday document. Please use the document
Administration, 10903 New Hampshire number 1754 to identify the guidance
through Friday. Ave., Bldg. 66, Rm. 4108, Silver Spring,
• Confidential Submissions—To you are requesting.
MD 20993–0002, 301–796–6062.
submit a comment with confidential IV. Paperwork Reduction Act of 1995
information that you do not wish to be SUPPLEMENTARY INFORMATION:
made publicly available, submit your This guidance refers to previously
I. Background
comments only as a written/paper approved collections of information
Section 522 of the FD&C Act (21 found in FDA regulations. These
submission. You should submit two
U.S.C. 360l) provides FDA with the collections of information are subject to
copies total. One copy will include the authority to require manufacturers to
information you claim to be confidential review by the Office of Management and
conduct postmarket surveillance of Budget (OMB) under the Paperwork
with a heading or cover note that states certain class II or class III devices. This
‘‘THIS DOCUMENT CONTAINS Reduction Act of 1995 (44 U.S.C. 3501–
guidance is intended to assist 3520). The collections of information in
CONFIDENTIAL INFORMATION.’’ The manufacturers of devices subject to
Agency will review this copy, including 21 CFR part 822 have been approved
section 522 postmarket surveillance under 0910–0449.
the claimed confidential information, in orders by providing an overview of
its consideration of comments. The Dated: May 10, 2016.
section 522 of the FD&C Act,
second copy, which will have the information on how to fulfill section Leslie Kux,
claimed confidential information 522 obligations, and recommendations Associate Commissioner for Policy.
redacted/blacked out, will be available on the format, content, and review of [FR Doc. 2016–11450 Filed 5–13–16; 8:45 am]
for public viewing and posted on http:// postmarket surveillance plan BILLING CODE 4164–01–P
www.regulations.gov. Submit both submissions.
copies to the Division of Dockets FDA issued the draft of this guidance,
Management. If you do not wish your originally entitled ‘‘Draft Guidance for DEPARTMENT OF HEALTH AND
name and contact information to be Industry and Food and Drug HUMAN SERVICES
made publicly available, you can Administration Staff; Procedures for
provide this information on the cover Handling Section 522 Postmarket Food and Drug Administration
sheet and not in the body of your Surveillance Studies,’’ on August 16,
comments and you must identify this [Docket No. FDA–2012–N–1203]
2011 (76 FR 50740). The comment
information as ‘‘confidential.’’ Any period ended on November 14, 2011. Agency Information Collection
information marked as ‘‘confidential’’ This document supersedes the Activities; Submission for Office of
will not be disclosed except in
asabaliauskas on DSK3SPTVN1PROD with NOTICES
guidance entitled, ‘‘Guidance for Management and Budget Review;
accordance with 21 CFR 10.20 and other Industry and FDA Staff; Postmarket Comment Request; Information To
applicable disclosure law. For more Surveillance under Section 522 of the Accompany Humanitarian Device
information about FDA’s posting of Federal Food, Drug, and Cosmetic Act,’’ Exemption Applications and Annual
comments to public dockets, see 80 FR dated April 27, 2006. Distribution Number Reporting
56469, September 18, 2015, or access Requirements
the information at: http://www.fda.gov/ II. Significance of Guidance
regulatoryinformation/dockets/ This guidance is being issued AGENCY: Food and Drug Administration,
default.htm. consistent with FDA’s good guidance HHS.
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![30314 Federal Register / Vol. 81, No. 94 / Monday, May 16, 2016 / Notices
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1—Continued
Number of Average
Number of Total annual
Activity/section of FD&C Act (as amended) or FDASIA responses per burden per Total hours
respondents responses
respondent response
Exemption from Profit Prohibition Information—
520(m)(6)(A)(i) and (ii) of the FD&C Act .......................... 3 1 3 50 150
Request for Determination of Eligibility Criteria—613(b) of
FDASIA ............................................................................. 2 1 2 10 20
ADN Notification—520(m)(6)(A)(iii) of the FD&C Act .......... 1 1 1 100 100
ADN Modification—520(m)(6)(C) of the FD&C Act ............. 5 1 5 100 500
Total .............................................................................. ........................ ........................ ........................ ........................ 1,370
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
FDA’s Center for Devices and Correction Contact Person: Giuseppe Pintucci, Ph.D.,
Radiological Health receives an Scientific Review Officer, Office of Scientific
In the Federal Register of April 7, Review/DERA, National Heart, Lung, and
estimated average of six HDE 2016, in FR Doc. 2016–07950, on page
applications per year. FDA estimates Blood Institute, 6701 Rockledge Drive, Room
20396, in the second column, under the 7192, Bethesda, MD 20892, 301–435–0287,
that three of these applications will be heading ‘‘II. Award Information, Pintuccig@nhlbi.nih.gov.
indicated for pediatric use. We estimate Estimated Funds Available,’’ the correct (Catalogue of Federal Domestic Assistance
that we will receive approximately two first sentence should read as follows: Program Nos. 93.233, National Center for
requests for determination of eligibility The total amount of funding Sleep Disorders Research; 93.837, Heart and
criteria per year. FDA estimates that identified for the current fiscal year (FY) Vascular Diseases Research; 93.838, Lung
very few or no HDE holders will notify 2016 is approximately $2,412,000. Diseases Research; 93.839, Blood Diseases
the Agency that the number of devices and Resources Research, National Institutes
Dated: May 4, 2016.
distributed in the year has exceeded the of Health, HHS)
Mary Smith,
ADN. FDA estimates that five HDE Dated: May 10, 2016.
holders will petition to have the ADN Principal Deputy Director, Indian Health
Service. Michelle Trout,
modified due to additional information
[FR Doc. 2016–11545 Filed 5–13–16; 8:45 am] Program Analyst, Office of Federal Advisory
on the number of individuals affected Committee Policy.
by the disease or condition. BILLING CODE 4165–16–P
[FR Doc. 2016–11397 Filed 5–13–16; 8:45 am]
Dated: May 11, 2016. BILLING CODE 4140–01–P
Leslie Kux, DEPARTMENT OF HEALTH AND
Associate Commissioner for Policy. HUMAN SERVICES
[FR Doc. 2016–11532 Filed 5–13–16; 8:45 am]
DEPARTMENT OF HEALTH AND
National Institutes of Health HUMAN SERVICES
BILLING CODE 4164–01–P
National Heart, Lung, and Blood National Institutes of Health
Institute: Notice of Closed Meeting
DEPARTMENT OF HEALTH AND Center for Scientific Review; Notice of
HUMAN SERVICES Pursuant to section 10(d) of the Closed Meetings
Federal Advisory Committee Act, as
Indian Health Service amended (5 U.S.C. App.), notice is Pursuant to section 10(d) of the
hereby given of the following meeting. Federal Advisory Committee Act, as
Tribal Management Grant Program; The meeting will be closed to the amended (5 U.S.C. App.), notice is
Correction public in accordance with the hereby given of the following meetings.
provisions set forth in sections
AGENCY: Indian Health Service, HHS. 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., The meetings will be closed to the
as amended. The grant applications and public in accordance with the
ACTION: Notice; correction. provisions set forth in sections
the discussions could disclose
confidential trade secrets or commercial 552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
SUMMARY: The Indian Health Service property such as patentable material, as amended. The grant applications and
published a document in the Federal and personal information concerning the discussions could disclose
Register on April 7, 2016, for the FY individuals associated with the grant confidential trade secrets or commercial
2016 Tribal Management Grant Program. applications, the disclosure of which property such as patentable material,
The notice contained the incorrect would constitute a clearly unwarranted and personal information concerning
Fiscal Year regarding funding invasion of personal privacy. individuals associated with the grant
availability. applications, the disclosure of which
Name of Committee: Heart, Lung, and
asabaliauskas on DSK3SPTVN1PROD with NOTICES
would constitute a clearly unwarranted
FOR FURTHER INFORMATION CONTACT: Blood Initial Review Group; NHLBI invasion of personal privacy.
Michelle Eagle Hawk, Deputy Director, Mentored Transition to Independence
Review Committee. Name of Committee: Infectious Diseases
Office of Direct Service and Contracting
Date: June 9–10, 2016. and Microbiology Integrated Review Group;
Tribes, Indian Health Service, 5600 Time: 8:00 a.m. to 5:00 p.m. Virology—B Study Section.
Fishers Lane, Mail Stop 08E17, Agenda: To review and evaluate grant Date: June 6–7, 2016.
Rockville, MD 20857, telephone (301) applications Time: 8:30 a.m. to 5:00 p.m.
443–1104. (This is not a toll-free Place: The William F. Bolger Center, 9600 Agenda: To review and evaluate grant
number.) Newbridge Drive, Potomac, MD 20854. applications.
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Document Created: 2016-05-14 01:17:04
Document Modified: 2016-05-14 01:17:04
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice. | |
| Dates | Fax written comments on the collection of information by June 15, 2016. | |
| Contact | FDA PRA Staff, Office of Operations, Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver Spring, MD 20993-0002, [email protected] | |
| FR Citation | 81 FR 30312 |
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