Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Guidance for Industry on Formal Meetings Between the Food and Drug Administration and Biosimilar Biological Product Sponsors or Applicants, 66543 [2015-27558]

Download as PDF Federal Register / Vol. 80, No. 209 / Thursday, October 29, 2015 / Notices 66543 TABLE 3—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1 54.4(b)—Clinical Investigators .......................................... 1 There Number of disclosures per respondent Number of respondents 21 CFR Section 7,106 1 OMB control number 0910–0802. 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. [FR Doc. 2015–27559 Filed 10–28–15; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Dated: October 23, 2015. Leslie Kux, Associate Commissioner for Policy. Food and Drug Administration [FR Doc. 2015–27558 Filed 10–28–15; 8:45 am] BILLING CODE 4164–01–P [Docket No. FDA–2013–D–0286] Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Guidance for Industry on Formal Meetings Between the Food and Drug Administration and Biosimilar Biological Product Sponsors or Applicants AGENCY: Food and Drug Administration, HHS. ACTION: 7,106 Average burden per disclosure 0.17 (10 minutes) ..... Total hours 1,208 are no capital costs or operating and maintenance costs associated with this collection of information. Dated: October 23, 2015. Leslie Kux, Associate Commissioner for Policy. Notice. The Food and Drug Administration (FDA) is announcing that a collection of information entitled ‘‘Guidance for Industry on Formal Meetings Between the Food and Drug Administration and Biosimilar Biological Product Sponsors or Applicant’’ 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, PRAStaff@ fda.hhs.gov. SUPPLEMENTARY INFORMATION: On June 25, 2015, the Agency submitted a proposed collection of information entitled ‘‘Guidance for Industry on Formal Meetings Between the Food and Drug Administration and Biosimilar Biological Product Sponsors or Applicant’’ 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 SUMMARY: asabaliauskas on DSK5VPTVN1PROD with NOTICES Total annual disclosures VerDate Sep<11>2014 23:37 Oct 28, 2015 Jkt 238001 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2015–N–3579] Using Technologies and Innovative Methods To Conduct Food and Drug Administration-Regulated Clinical Investigations of Investigational Drugs; Establishment of a Public Docket AGENCY: Food and Drug Administration, HHS. Notice; establishment of docket; request for comments. ACTION: The Food and Drug Administration (FDA or Agency) is announcing the establishment of a public docket to solicit input from a broad group of stakeholders on the scope and direction of the use of technologies and innovative methods in the conduct of clinical investigations. Specifically, FDA seeks information to understand individual and industry experiences with the use of such technologies to more efficiently conduct clinical research. FDA also seeks stakeholder perspectives on possible barriers to implementing these technologies and methods to conduct clinical investigations. DATES: Submit electronic or written comments by December 28, 2015. ADDRESSES: You may submit comments as follows: SUMMARY: Electronic Submissions Submit electronic comments in the following way: • Federal eRulemaking Portal: https:// www.regulations.gov. Follow the PO 00000 Frm 00056 Fmt 4703 Sfmt 4703 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 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–3579 for ‘‘Using Technologies and Innovative Methods to Conduct FDA-Regulated Clinical Investigations of Investigational Drugs.’’ Please identify the specific question or issue that the comment addresses. 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. E:\FR\FM\29OCN1.SGM 29OCN1

Agencies

[Federal Register Volume 80, Number 209 (Thursday, October 29, 2015)]
[Notices]
[Page 66543]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-27558]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-D-0286]


Agency Information Collection Activities; Announcement of Office 
of Management and Budget Approval; Guidance for Industry on Formal 
Meetings Between the Food and Drug Administration and Biosimilar 
Biological Product Sponsors or Applicants

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing that a 
collection of information entitled ``Guidance for Industry on Formal 
Meetings Between the Food and Drug Administration and Biosimilar 
Biological Product Sponsors or Applicant'' 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, PRAStaff@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: On June 25, 2015, the Agency submitted a 
proposed collection of information entitled ``Guidance for Industry on 
Formal Meetings Between the Food and Drug Administration and Biosimilar 
Biological Product Sponsors or Applicant'' 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 
0910-0802. 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 23, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-27558 Filed 10-28-15; 8:45 am]
 BILLING CODE 4164-01-P

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