2018-16156. Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

SUMMARY:

The Food and Drug Administration (FDA) is publishing a list of information collections that have been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.

FOR FURTHER INFORMATION CONTACT:

Ila S. Mizrachi, Office of Operations, Food and Drug Administration, Three White Flint North, 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-7726, [e-mail].

SUPPLEMENTARY INFORMATION:

The following is a list of FDA information collections recently approved by OMB under section 3507 of the Paperwork Reduction Act of 1995 (44 U.S.C. 3507). The OMB control number and expiration date of OMB approval for each information collection are shown in table 1. Copies of the supporting statements for the information collections are available on the internet at https://www.reginfo.gov/​public/​do/​PRAMain. 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.

Table 1—List of Information Collections Approved by OMB

Title of collection	OMB control No.	Date approval expires
Blood Establishment Registration and Product Listing for Manufacturers of Human Blood and Blood Products and Licensed Devices; Form FDA 2830	0910-0052	6/30/2021
Current Good Manufacturing Practices and Related Regulations for Blood and Blood Components; and Requirements for Donation Testing, Donor Notification, and “Lookback”	0910-0116	6/30/2021
Current Good Manufacturing Practices for Finished Pharmaceuticals and Medical Gases	0910-0139	6/30/2021
Prescription Drug Marketing	0910-0435	6/30/2021
Prominent and Conspicuous Mark of Manufacturers on Single-Use Devices	0910-0577	6/30/2021
Guidance FDA and Industry Procedures for Section 513(g) Requests for Information under the Federal Food, Drug, and Cosmetic Act	0910-0705	6/30/2021
Utilization of Adequate Provision Among Low to Non-Internet Users	0910-0853	6/30/2021
Record Retention Requirements for the Soy Protein/Coronary Heart Disease Health Claim	0910-0428	7/31/2021

Dated: July 24, 2018.

Leslie Kux,

Associate Commissioner for Policy.