Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Reclassification Petitions for Medical Devices, 63227-63228 [2015-26434]

Download as PDF Federal Register / Vol. 80, No. 201 / Monday, October 19, 2015 / Notices Dated: October 13, 2015. Leslie Kux, Associate Commissioner for Policy. include the FDA docket number found in brackets in the heading of this document. [FR Doc. 2015–26439 Filed 10–16–15; 8:45 am] FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations, Food and Drug Administration, 8455 Colesville Rd., COLE–14526, Silver Spring, MD 20993–0002, PRAStaff@ fda.hhs.gov. BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance. SUPPLEMENTARY INFORMATION: [Docket No. FDA–2012–N–0471] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; User Fee Cover Sheet; Form FDA 3397 AGENCY: User Fee Cover Sheet; Form FDA 3397 (OMB Control Number 0910–0297)— Extension 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 November 18, 2015. 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 0910–0297. Also SUMMARY: Under the prescription drug user fee provisions of the Federal Food, Drug, and Cosmetic Act (sections 735 and 736 (21 U.S.C. 379g and 379h)), as amended, FDA has the authority to assess and collect user fees for certain drug and biologics license applications (BLAs) and supplements to those applications. Under this authority, pharmaceutical companies pay a fee for certain new human drug applications (NDAs), BLAs, or supplements submitted to the Agency for review. Because the submission of user fees concurrently with applications and supplements is required, review of an application by FDA cannot begin until the fee is submitted. The Prescription Drug User Fee Cover Sheet, Form FDA 3397, is designed to provide the minimum necessary information to determine whether a fee is required for review of an application, to determine the amount of the fee required, and to account for and track user fees. The 63227 form provides a cross-reference of the fee submitted for an application by using a unique number tracking system. The information collected is used by FDA’s Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER) to initiate the administrative screening of NDAs, BLAs, and/or, supplemental applications to those applications. Respondents to this collection of information are new drug and biologics manufacturers. Based on FDA’s database system for fiscal year (FY) 2014, there are an estimated 290 manufacturers of products subject to the Prescription Drug User Fee Act (Pub. L. 105–115). The total number of annual responses is based on the number of submissions received by FDA in FY 2014. CDER received 3,005 annual responses that include the following submissions: 128 NDAs; 7 BLAs; 1,586 manufacturing supplements; 1,081 labeling supplements; and 203 efficacy supplements. CBER received 705 annual responses that include the following submissions: 11 BLAs; 611 manufacturing supplements; 64 labeling supplements; and 19 efficacy supplements. The estimated hours per response are based on past FDA experience with the various submissions. In the Federal Register of April 15, 2015 (80 FR 20232), 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 FDA Form Number of respondents Number of responses per respondent Total annual responses Average burden per response Total hours FDA 3397 ............................................................................. 290 12.79 3,710 0.5 (30 min.) 1,855 1 There are no capital costs or operating and maintenance costs associated with this collection of information. Dated: October 13, 2015. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2015–26435 Filed 10–16–15; 8:45 am] asabaliauskas on DSK5VPTVN1PROD with NOTICES BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2011–N–0776] Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Reclassification Petitions for Medical Devices AGENCY: Food and Drug Administration, HHS. VerDate Sep<11>2014 17:52 Oct 16, 2015 Jkt 238001 PO 00000 Frm 00035 Fmt 4703 Sfmt 4703 ACTION: Notice. The Food and Drug Administration (FDA) is announcing that a collection of information entitled ‘‘Reclassification Petitions for Medical Devices’’ has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995. SUMMARY: FDA PRA Staff, Office of Operations, Food and Drug Administration, 8455 Colesville Rd., COLE–14526, Silver FOR FURTHER INFORMATION CONTACT: E:\FR\FM\19OCN1.SGM 19OCN1 63228 Federal Register / Vol. 80, No. 201 / Monday, October 19, 2015 / Notices Spring, MD 20993–0002, PRAStaff@ fda.hhs.gov. SUPPLEMENTARY INFORMATION: On June 16, 2015, the Agency submitted a proposed collection of information entitled ‘‘Reclassification Petitions for Medical Devices’’ 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 0910–0138. The approval expires on September 30, 2018. A copy of the supporting statement for this information collection is available on the Internet at https:// www.reginfo.gov/public/do/PRAMain. Dated: October 13, 2015. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2015–26434 Filed 10–16–15; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2015–N–3655] Agency Information Collection Activities; Proposed Collection; Comment Request; Recordkeeping Requirements for Microbiological Testing and Corrective Measures for Bottled Water AGENCY: Food and Drug Administration, Notice. The Food and Drug Administration (FDA or we) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the procedure by which both domestic and foreign bottled water manufacturers that sell bottled water in the United States maintain records of microbiological testing and corrective measures, in addition to existing recordkeeping requirements. DATES: Submit either electronic or written comments on the collection of information by December 18, 2015. asabaliauskas on DSK5VPTVN1PROD with NOTICES SUMMARY: VerDate Sep<11>2014 17:52 Oct 16, 2015 Jkt 238001 You may submit comments as follows: Electronic Submissions Submit electronic comments in the following way: • Federal eRulemaking Portal: https:// www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to https:// www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else’s Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on https://www.regulations.gov. • If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see ‘‘Written/Paper Submissions’’ and ‘‘Instructions’’). Written/Paper Submissions HHS. ACTION: ADDRESSES: Submit written/paper submissions as follows: • Mail/Hand delivery/Courier (for written/paper submissions): Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. • For written/paper comments submitted to the Division of Dockets Management, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in ‘‘Instructions’’. Instructions: All submissions received must include the Docket No. FDA– 2015–N–3655 for the information collection request entitled, ‘‘Agency Information Collection Activities; Proposed Collection; Comment Request; Recordkeeping Requirements for Microbiological Testing and Corrective Measures for Bottled Water’’. Received comments will be placed in the docket and, except for those submitted as ‘‘Confidential Submissions’’, publicly viewable at https://www.regulations.gov or at the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. PO 00000 Frm 00036 Fmt 4703 Sfmt 4703 • Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states ‘‘THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION’’. The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on https:// www.regulations.gov. Submit both copies to the Division of Dockets Management. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as ‘‘confidential’’. Any information marked as ‘‘confidential’’ will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA’s posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: https://www.fda.gov/ regulatoryinformation/dockets/ default.htm. Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to https:// www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the ‘‘Search’’ box and follow the prompts and/or go to the Division of Dockets Management, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations, Food and Drug Administration, 8455 Colesville Rd., COLE–14526, Silver Spring, MD 20993–0002, PRAStaff@ fda.hhs.gov. SUPPLEMENTARY INFORMATION: 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 E:\FR\FM\19OCN1.SGM 19OCN1

Agencies

[Federal Register Volume 80, Number 201 (Monday, October 19, 2015)]
[Notices]
[Pages 63227-63228]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-26434]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0776]


Agency Information Collection Activities; Announcement of Office 
of Management and Budget Approval; Reclassification Petitions for 
Medical Devices

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing that a 
collection of information entitled ``Reclassification Petitions for 
Medical Devices'' 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

[[Page 63228]]

Spring, MD 20993-0002, PRAStaff@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: On June 16, 2015, the Agency submitted a 
proposed collection of information entitled ``Reclassification 
Petitions for Medical Devices'' 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 0910-0138. 
The approval expires on September 30, 2018. A copy of the supporting 
statement for this information collection is available on the Internet 
at https://www.reginfo.gov/public/do/PRAMain.

    Dated: October 13, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-26434 Filed 10-16-15; 8:45 am]
 BILLING CODE 4164-01-P

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.