80 FR 30689 - 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
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 80, Issue 103 (May 29, 2015)
Food and Drug Administration
Federal Register Volume 80, Issue 103 (May 29, 2015)
| Page Range | 30689-30689 | |
| FR Document | 2015-12977 |
[Federal Register Volume 80, Number 103 (Friday, May 29, 2015)] [Notices] [Page 30689] From the Federal Register Online [www.thefederalregister.org] [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, [email protected]. 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 http://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
![Federal Register / Vol. 80, No. 103 / Friday, May 29, 2015 / Notices 30689
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1—Continued
Number of Average
Number of Total annual
21 CFR Section responses per burden per Total hours
respondents responses
respondent response
Total .............................................................................. ........................ ........................ ........................ ........................ 26,020
1 There 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 dis- Average
Number of Total annual
21 CFR Section closures per burden per Total hours
respondents disclosures
respondent disclosure
208.24(c) ................................................................................ 191 9,000 1,719,000 1.25 ............. 2,148,750
Distributing and Dispensing a Medication Guide—208.24(e) 88,736 5,000 443,680,000 0.05 (3 min- 22,184,000
utes).
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. entitled, ‘‘Guidance for Industry on Guidelines for Federal Workplace Drug
Leslie Kux, Postmarketing Adverse Event Reporting Testing Programs (hair specimen).
Associate Commissioner for Policy. for Medical Products and Dietary DATES: Comment Close Date: To be
[FR Doc. 2015–12976 Filed 5–28–15; 8:45 am] Supplements During an Influenza assured consideration, comments must
BILLING CODE 4164–01–P
Pandemic’’ to OMB for review and be received at one of the addresses
clearance under 44 U.S.C. 3507. An provided below on or before June 29,
Agency may not conduct or sponsor, 2015.
DEPARTMENT OF HEALTH AND and a person is not required to respond
ADDRESSES: Because of staff and
HUMAN SERVICES to, a collection of information unless it
resource limitations, we cannot accept
displays a currently valid OMB control
Food and Drug Administration comments by facsimile (FAX)
number. OMB has now approved the
transmission. You may submit
information collection and has assigned
[Docket No. FDA–2014–N–1081] comments in one of four ways (please
OMB control number 0910–0701. The
choose only one of the ways listed):
Agency Information Collection approval expires on April 30, 2018. A
Electronically: You may submit
Activities; Announcement of Office of copy of the supporting statement for this
electronic comments to http://
Management and Budget Approval; information collection is available on
www.regulations.gov. Follow ‘‘Submit a
Guidance for Industry on the Internet at http://www.reginfo.gov/
comment’’ instructions.
Postmarketing Adverse Event public/do/PRAMain.
By regular mail: You may mail written
Reporting for Medical Products and Dated: May 22, 2015. comments to the following address only:
Dietary Supplements During an Leslie Kux, Substance Abuse and Mental Health
Influenza Pandemic Associate Commissioner for Policy. Services Administration, Attention:
AGENCY: Food and Drug Administration, [FR Doc. 2015–12977 Filed 5–28–15; 8:45 am] Division of Workplace Programs, 1
HHS. BILLING CODE 4164–01–P Choke Cherry Road, Room 7–1029,
Rockville, MD 20857. Please allow
ACTION: Notice. sufficient time for mailed comments to
SUMMARY: The Food and Drug DEPARTMENT OF HEALTH AND be received before the close of the
Administration (FDA) is announcing HUMAN SERVICES comment period.
that a collection of information entitled, By express or overnight mail: You
Substance Abuse and Mental Health may send written comments to the
‘‘Guidance for Industry on
Services Administration following address only: Substance
Postmarketing Adverse Event Reporting
for Medical Products and Dietary Abuse and Mental Health Services
Mandatory Guidelines for Federal Administration, Attention: Division of
Supplements During an Influenza Workplace Drug Testing Programs;
Pandemic’’ has been approved by the Workplace Programs, 1 Choke Cherry
Request for Information Regarding Road, Room 7–1029, Rockville, MD
Office of Management and Budget Specific Issues Related to the Use of
(OMB) under the Paperwork Reduction 20850.
the Hair Specimen for Drug Testing By hand or courier: Alternatively, you
Act of 1995.
AGENCY: Substance Abuse and Mental may deliver (by hand or courier) your
FOR FURTHER INFORMATION CONTACT: FDA
Health Services Administration written comments only to the following
PRA Staff, Office of Operations, Food address prior to the close of the
and Drug Administration, 8455 (SAMHSA), Department of Health and
Lhorne on DSK2VPTVN1PROD with NOTICES
Human Services (DHHS). comment period:
Colesville Rd., COLE–14526, Silver For delivery in Rockville, MD:
Spring, MD 20993–0002, PRAStaff@ ACTION: Request for Information.
Substance Abuse and Mental Health
fda.hhs.gov. SUMMARY: This document is a request for Services Administration, Attention:
SUPPLEMENTARY INFORMATION: On information regarding specific aspects of Division of Workplace Programs, 1
January 8, 2015, the Agency submitted the regulatory policies and standards Choke Cherry Road, Room 7–1029,
a proposed collection of information that may be applied to the Mandatory Rockville, MD 20850. To deliver your
VerDate Sep<11>2014 15:17 May 28, 2015 Jkt 235001 PO 00000 Frm 00039 Fmt 4703 Sfmt 4703 E:\FR\FM\29MYN1.SGM 29MYN1](https://thefederalregister.org/doc/80_FR_30792/page/1.svg)
Document Created: 2015-12-15 15:31:27
Document Modified: 2015-12-15 15:31:27
| 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. | |
| 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 | 80 FR 30689 |
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