81_FR_5785 81 FR 5763 - Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Biosimilar User Fee Cover Sheet; Form FDA 3792

81 FR 5763 - Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Biosimilar User Fee Cover Sheet; Form FDA 3792

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 81, Issue 22 (February 3, 2016)

Page Range5763-5764
FR Document2016-01883

The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Biosimilar User Fee Cover Sheet; Form FDA 3792'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.

Federal Register, Volume 81 Issue 22 (Wednesday, February 3, 2016) 
[Federal Register Volume 81, Number 22 (Wednesday, February 3, 2016)]
[Notices]
[Pages 5763-5764]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-01883]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-N-0194]


Agency Information Collection Activities; Announcement of Office 
of Management and Budget Approval; Biosimilar User Fee Cover Sheet; 
Form FDA 3792

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing that a 
collection of information entitled ``Biosimilar User Fee Cover Sheet; 
Form FDA 3792'' has been approved by the Office of Management and 
Budget (OMB) under the Paperwork Reduction Act of 1995.

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: On June 23, 2015, the Agency submitted a 
proposed collection of information entitled ``Biosimilar User Fee Cover 
Sheet; Form FDA 3792'' to OMB for review and clearance under 44 U.S.C. 
3507. An Agency may not conduct or sponsor, and a person is not 
required to respond to, a collection of information unless it displays 
a currently valid OMB control number. OMB has now approved the 
information collection and has assigned OMB control number 0910-0718. 
The approval expires on December 31, 2018. A copy of the supporting 
statement for this

[[Page 5764]]

information collection is available on the Internet at http://www.reginfo.gov/public/do/PRAMain.

    Dated: January 28, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-01883 Filed 2-2-16; 8:45 am]
 BILLING CODE 4164-01-P

Federal Register / Vol. 81, No. 22 / Wednesday, February 3, 2016 / Notices 5763 Development, Center for Devices and collecting human factors data as part of under OMB control number 0910–0231; Radiological Health, Food and Drug a clinical study. In response to these the collections of information in 21 CFR Administration, 10903 New Hampshire comments, FDA revised the guidance part 814, subpart H are approved under Ave., Bldg. 66, Rm. 5431, Silver Spring, document to clarify the points identified OMB control number 0910–0332; the MD 20993–0002. Send one self- and restructured the information for collections of information in 21 CFR addressed adhesive label to assist that better readability and comprehension. parts 801 and 809 are approved under office in processing your request. This guidance supersedes the guidance OMB control number 0910–0485; and FOR FURTHER INFORMATION CONTACT: entitled ‘‘Medical Device Use-Safety: the collections of information in the Shannon Hoste, Center for Devices and Incorporating Human Factors guidance document entitled ‘‘Requests Radiological Health, Food and Drug Engineering into Risk Management’’ for Feedback on Medical Device Administration, 10903 New Hampshire dated July 18, 2000, which will be Submissions: The Pre-Submission Ave., Bldg. 66, Rm. 2531, Silver Spring, withdrawn. Program and Meetings with Food and MD 20993–0002, 240–402–3747 or II. Significance of Guidance Drug Administration Staff’’ are Shannon.hoste@fda.hhs.gov. approved under OMB control number This guidance is being issued 0910–0756. SUPPLEMENTARY INFORMATION: consistent with FDA’s good guidance practices regulation (21 CFR 10.115). Dated: January 28, 2016. I. Background The guidance represents the current Leslie Kux, To understand use-related hazards, it thinking of FDA on ‘‘Applying Human Associate Commissioner for Policy. is necessary to have an accurate and Factors and Usability Engineering to [FR Doc. 2016–01887 Filed 2–2–16; 8:45 am] complete understanding of how a device Medical Devices.’’ It does not establish BILLING CODE 4164–01–P will be used. Understanding and any rights for any person and is not optimizing how people interact with binding on FDA or the public. You can technology is the subject of human use an alternative approach if it satisfies DEPARTMENT OF HEALTH AND factors engineering (HFE) and usability the requirements of the applicable HUMAN SERVICES engineering (UE). HFE/UE statutes and regulations. considerations in the development of Food and Drug Administration medical devices include the three major III. Electronic Access [Docket No. FDA–2012–N–0194] components of the device user system: Persons interested in obtaining a copy (1) Device users; (2) device use of the guidance may do so by Agency Information Collection environments; and (3) device user downloading an electronic copy from Activities; Announcement of Office of interfaces. the Internet. A search capability for all Management and Budget Approval; For safety-critical technologies such Center for Devices and Radiological Biosimilar User Fee Cover Sheet; Form as medical devices, the process of Health guidance documents is available FDA 3792 eliminating or reducing design-related at http://www.fda.gov/MedicalDevices/ use problems that contribute to or cause DeviceRegulationandGuidance/ AGENCY: Food and Drug Administration, unsafe or ineffective medical treatment GuidanceDocuments/default.htm. HHS. is part of a process for controlling Guidance documents are also available ACTION: Notice. overall risk. For devices where harm at http://www.regulations.gov. Persons SUMMARY: The Food and Drug could result from ‘‘use errors,’’ the unable to download an electronic copy Administration (FDA) is announcing dynamics of user interaction should be of ‘‘Applying Human Factors and that a collection of information entitled included in risk analysis and risk Usability Engineering to Medical ‘‘Biosimilar User Fee Cover Sheet; Form management. By incorporating these Devices’’ may send an email request to FDA 3792’’ has been approved by the considerations into the device CDRH-Guidance@fda.hhs.gov to receive Office of Management and Budget development process, manufacturers an electronic copy of the document. (OMB) under the Paperwork Reduction can reduce the overall risk level posed Please use the document number 1747 Act of 1995. by their devices, thus decreasing to identify the guidance you are adverse events associated with the FOR FURTHER INFORMATION CONTACT: FDA requesting. device and avoiding potential device PRA Staff, Office of Operations, Food recalls. IV. Paperwork Reduction Act of 1995 and Drug Administration, 8455 In the Federal Register of June 22, This guidance refers to previously Colesville Rd., COLE–14526, Silver 2011 (76 FR 36543), FDA announced the approved collections of information Spring, MD 20993–0002, PRAStaff@ availability of the draft guidance found in FDA regulations and guidance. fda.hhs.gov. document. Interested persons were These collections of information are SUPPLEMENTARY INFORMATION: On June invited to comment by September 19, subject to review by the Office of 23, 2015, the Agency submitted a 2011. FDA received over 600 comments, Management and Budget (OMB) under proposed collection of information which were generally supportive of the the Paperwork Reduction Act of 1995 entitled ‘‘Biosimilar User Fee Cover draft guidance document, but requested (44 U.S.C. 3501–3520). The collections Sheet; Form FDA 3792’’ to OMB for clarification in a number of areas. The of information in 21 CFR part 820 are review and clearance under 44 U.S.C. most frequent types of comments approved under OMB control number 3507. An Agency may not conduct or requested revisions to the language or 0910–0073; the collections of sponsor, and a person is not required to mstockstill on DSK4VPTVN1PROD with NOTICES structure of the document, or information in 21 CFR part 812 are respond to, a collection of information clarification on risk mitigation and approved under OMB control number unless it displays a currently valid OMB human factors testing methods, user 0910–0078; the collections of control number. OMB has now populations for testing, training of test information in 21 CFR part 807, subpart approved the information collection and participants, determining the E are approved under OMB control has assigned OMB control number appropriate sample size in human number 0910–0120; the collections of 0910–0718. The approval expires on factors testing, reporting of testing information in 21 CFR part 814, December 31, 2018. A copy of the results in premarket submissions, and subparts A through E are approved supporting statement for this VerDate Sep<11>2014 19:14 Feb 02, 2016 Jkt 238001 PO 00000 Frm 00061 Fmt 4703 Sfmt 4703 E:\FR\FM\03FEN1.SGM 03FEN1

5764 Federal Register / Vol. 81, No. 22 / Wednesday, February 3, 2016 / Notices information collection is available on DEPARTMENT OF HEALTH AND DEPARTMENT OF HEALTH AND the Internet at http://www.reginfo.gov/ HUMAN SERVICES HUMAN SERVICES public/do/PRAMain. Food and Drug Administration Food and Drug Administration Dated: January 28, 2016. Leslie Kux, [Docket No. FDA–2015–D–4848] Associate Commissioner for Policy. [Docket No. FDA–2011–N–0915] Human Factors Studies and Related [FR Doc. 2016–01883 Filed 2–2–16; 8:45 am] Agency Information Collection Clinical Study Considerations in BILLING CODE 4164–01–P Activities; Announcement of Office of Combination Product Design and Management and Budget Approval; Development; Draft Guidance for Guidance for Industry on Industry and Food and Drug DEPARTMENT OF HEALTH AND Administration Staff; Availability Postmarketing Adverse Event HUMAN SERVICES Reporting for Nonprescription Human AGENCY: Food and Drug Administration, Food and Drug Administration Drug Products Marketed Without an HHS. Approved Application ACTION: Notice. [Docket No. FDA–2012–N–0253] AGENCY: Food and Drug Administration, SUMMARY: The Food and Drug Agency Information Collection HHS. Administration (FDA or Agency) is Activities; Announcement of Office of announcing the availability of a draft ACTION: Notice. Management and Budget Approval; guidance for industry and FDA staff Postmarketing Adverse Drug entitled ‘‘Human Factors Studies and SUMMARY: The Food and Drug Related Clinical Study Considerations Experience Reporting Administration (FDA) is announcing in Combination Product Design and that a collection of information entitled Development.’’ This document provides AGENCY: Food and Drug Administration, ‘‘Guidance for Industry on guidance to industry and FDA staff on HHS. Postmarketing Adverse Event Reporting the underlying principles of human ACTION: Notice. for Nonprescription Human Drug factors (HF) studies during the Products Marketed Without an development of combination products. SUMMARY: The Food and Drug Approved Application’’ has been Combination products are comprised of Administration (FDA) is announcing approved by the Office of Management any combination of a drug and a device; that a collection of information entitled and Budget (OMB) under the Paperwork a device and a biological product; a ‘‘Postmarketing Adverse Drug Reduction Act of 1995. biological product and a drug; or a drug, Experience Reporting’’ has been a device, and a biological product. approved by the Office of Management FOR FURTHER INFORMATION CONTACT: FDA DATES: Although you can comment on and Budget (OMB) under the Paperwork PRA Staff, Office of Operations, Food any guidance at any time (see 21 CFR Reduction Act of 1995. and Drug Administration, 8455 10.115(g)(5)), to ensure that the Agency Colesville Rd., COLE–14526, Silver FOR FURTHER INFORMATION CONTACT: FDA considers your comments on this draft Spring, MD 20993–0002, PRAStaff@ PRA Staff, Office of Operations, Food guidance before it begins work on the fda.hhs.gov. and Drug Administration, 8455 final version of the guidance, submit Colesville Rd., COLE–14526, Silver SUPPLEMENTARY INFORMATION: On July 2, either electronic or written comments Spring, MD 20993–0002, PRAStaff@ 2015, the Agency submitted a proposed on the draft guidance by May 3, 2016. fda.hhs.gov. collection of information entitled ADDRESSES: You may submit comments ‘‘Guidance for Industry on as follows: SUPPLEMENTARY INFORMATION: On July 1, Postmarketing Adverse Event Reporting 2015, the Agency submitted a proposed Electronic Submissions for Nonprescription Human Drug collection of information entitled Submit electronic comments in the Products Marketed Without an ‘‘Postmarketing Adverse Drug following way: Approved Application’’ to OMB for • Federal eRulemaking Portal: http:// Experience Reporting’’ to OMB for review and clearance under 44 U.S.C. www.regulations.gov. Follow the review and clearance under 44 U.S.C. 3507. An Agency may not conduct or instructions for submitting comments. 3507. An Agency may not conduct or sponsor, and a person is not required to Comments submitted electronically, sponsor, and a person is not required to respond to, a collection of information respond to, a collection of information including attachments, to http:// unless it displays a currently valid OMB unless it displays a currently valid OMB www.regulations.gov will be posted to control number. OMB has now control number. OMB has now the docket unchanged. Because your approved the information collection and approved the information collection and comment will be made public, you are has assigned OMB control number has assigned OMB control number solely responsible for ensuring that your 0910–0230. The approval expires on 0910–0636. The approval expires on comment does not include any December 31, 2018. A copy of the December 31, 2018. A copy of the confidential information that you or a supporting statement for this supporting statement for this third party may not wish to be posted, information collection is available on information collection is available on such as medical information, your or mstockstill on DSK4VPTVN1PROD with NOTICES the Internet at http://www.reginfo.gov/ the Internet at http://www.reginfo.gov/ anyone else’s Social Security number, or public/do/PRAMain. public/do/PRAMain. confidential business information, such Dated: January 28, 2016. as a manufacturing process. Please note Dated: January 27, 2016. that if you include your name, contact Leslie Kux, Leslie Kux, information, or other information that Associate Commissioner for Policy. Associate Commissioner for Policy. identifies you in the body of your [FR Doc. 2016–01884 Filed 2–2–16; 8:45 am] [FR Doc. 2016–01885 Filed 2–2–16; 8:45 am] comments, that information will be BILLING CODE 4164–01–P BILLING CODE 4164–01–P posted on http://www.regulations.gov. VerDate Sep<11>2014 19:14 Feb 02, 2016 Jkt 238001 PO 00000 Frm 00062 Fmt 4703 Sfmt 4703 E:\FR\FM\03FEN1.SGM 03FEN1


Document Created: 2016-02-03 00:40:01
Document Modified: 2016-02-03 00:40:01
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice.
ContactFDA PRA Staff, Office of Operations, Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver Spring, MD 20993-0002, [email protected]
FR Citation81 FR 5763 
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