Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Guidance for Industry on Postmarketing Adverse Event Reporting for Medical Products and Dietary Supplements During an Influenza Pandemic, 30689 [2015-12977]

Download as PDF Federal Register / Vol. 80, No. 103 / Friday, May 29, 2015 / Notices 30689 TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1—Continued Number of respondents 21 CFR Section Total .............................................................................. 1 There Number of responses per respondent Total annual responses Average burden per response ........................ ........................ ........................ ........................ Total hours 26,020 are no capital costs or operating and maintenance costs associated with this collection of information. TABLE 2—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1 Number of respondents 21 CFR Section Number of disclosures per respondent Total annual disclosures Average burden per disclosure Total hours 208.24(c) ................................................................................ Distributing and Dispensing a Medication Guide—208.24(e) 191 88,736 9,000 5,000 1,719,000 443,680,000 1.25 ............. 0.05 (3 minutes). 2,148,750 22,184,000 Total ................................................................................ ........................ ........................ ........................ ..................... 24,332,750 1 There are no capital costs or operating and maintenance costs associated with this collection of information. Dated: May 22, 2015. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2015–12976 Filed 5–28–15; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2014–N–1081] Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Guidance for Industry on Postmarketing Adverse Event Reporting for Medical Products and Dietary Supplements During an Influenza Pandemic AGENCY: Food and Drug Administration, HHS. ACTION: Dated: May 22, 2015. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2015–12977 Filed 5–28–15; 8:45 am] BILLING CODE 4164–01–P Notice. The Food and Drug Administration (FDA) is announcing that a collection of information entitled, ‘‘Guidance for Industry on Postmarketing Adverse Event Reporting for Medical Products and Dietary Supplements During an Influenza Pandemic’’ 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. SUMMARY: Lhorne on DSK2VPTVN1PROD with NOTICES entitled, ‘‘Guidance for Industry on Postmarketing Adverse Event Reporting for Medical Products and Dietary Supplements During an Influenza Pandemic’’ 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 0910–0701. The approval expires on April 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. On January 8, 2015, the Agency submitted a proposed collection of information SUPPLEMENTARY INFORMATION: VerDate Sep<11>2014 15:17 May 28, 2015 Jkt 235001 DEPARTMENT OF HEALTH AND HUMAN SERVICES Substance Abuse and Mental Health Services Administration Mandatory Guidelines for Federal Workplace Drug Testing Programs; Request for Information Regarding Specific Issues Related to the Use of the Hair Specimen for Drug Testing Substance Abuse and Mental Health Services Administration (SAMHSA), Department of Health and Human Services (DHHS). ACTION: Request for Information. AGENCY: This document is a request for information regarding specific aspects of the regulatory policies and standards that may be applied to the Mandatory SUMMARY: PO 00000 Frm 00039 Fmt 4703 Sfmt 4703 Guidelines for Federal Workplace Drug Testing Programs (hair specimen). DATES: Comment Close Date: To be assured consideration, comments must be received at one of the addresses provided below on or before June 29, 2015. Because of staff and resource limitations, we cannot accept comments by facsimile (FAX) transmission. You may submit comments in one of four ways (please choose only one of the ways listed): Electronically: You may submit electronic comments to https:// www.regulations.gov. Follow ‘‘Submit a comment’’ instructions. By regular mail: You may mail written comments to the following address only: Substance Abuse and Mental Health Services Administration, Attention: Division of Workplace Programs, 1 Choke Cherry Road, Room 7–1029, Rockville, MD 20857. Please allow sufficient time for mailed comments to be received before the close of the comment period. By express or overnight mail: You may send written comments to the following address only: Substance Abuse and Mental Health Services Administration, Attention: Division of Workplace Programs, 1 Choke Cherry Road, Room 7–1029, Rockville, MD 20850. By hand or courier: Alternatively, you may deliver (by hand or courier) your written comments only to the following address prior to the close of the comment period: For delivery in Rockville, MD: Substance Abuse and Mental Health Services Administration, Attention: Division of Workplace Programs, 1 Choke Cherry Road, Room 7–1029, Rockville, MD 20850. To deliver your ADDRESSES: E:\FR\FM\29MYN1.SGM 29MYN1

Agencies

[Federal Register Volume 80, Number 103 (Friday, May 29, 2015)]
[Notices]
[Page 30689]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-12977]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-N-1081]


Agency Information Collection Activities; Announcement of Office 
of Management and Budget Approval; Guidance for Industry on 
Postmarketing Adverse Event Reporting for Medical Products and Dietary 
Supplements During an Influenza Pandemic

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 
Postmarketing Adverse Event Reporting for Medical Products and Dietary 
Supplements During an Influenza Pandemic'' 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 January 8, 2015, the Agency submitted a 
proposed collection of information entitled, ``Guidance for Industry on 
Postmarketing Adverse Event Reporting for Medical Products and Dietary 
Supplements During an Influenza Pandemic'' 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 
0910-0701. The approval expires on April 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: May 22, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-12977 Filed 5-28-15; 8:45 am]
 BILLING CODE 4164-01-P

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