Paperwork Reduction Act of 1995 Sample Clauses

Paperwork Reduction Act of 1995. A. CBER Guidances While these guidances contain no collection of information, they do refer to previously approved FDA collections of information (listed in table 2). Therefore, clearance by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501–3521) is not required for these guidances. The previously approved collections of information are subject to review by OMB under the PRA. The collections of information in the following FDA regulations and guidances have been approved by OMB as listed in the following table: TABLE 2—CBER GUIDANCES AND COLLECTIONS COVID–19 guidance title CFR cite referenced in COVID–19 guidance Another guidance title referenced in COVID–19 guidance OMB control No(s). Emergency Use Authorization for Vaccines to Prevent COVID–19 (Up- 21 CFR 314.420 ................. 0910–0001 dated: February 22, 2021). 21 CFR part 312 ................. 0910–0014 21 CFR parts 210, 211, and 0910–0139 610. 0910–0308 21 CFR part 600 ................. 0910–0338 21 CFR part 601 ................. Emergency Use Authorization of Medical Products and Related Au- 0910–0595 thorities. Investigational COVID–19 Convalescent Plasma; Guidance for Industry 21 CFR part 312 ................. 0910–0014 (Updated: February 11, 2021). 21 CFR parts 606 and 630 0910–0116 Form FDA 3926 ....................................................................................... 0910–0814 B. CDER Guidances While these guidances contain no collection of information, they do refer to previously approved FDA collections of information (listed in table 3). Therefore, clearance by OMB under the PRA (44 U.S.C. 3501–3521) is not required for these guidances. The previously approved collections of information are subject to review by OMB under the PRA. The collections of information in the following FDA regulations and guidances have been approved by OMB as listed in the following table: TABLE 3—CDER GUIDANCES AND COLLECTIONS COVID–19 guidance title CFR cite referenced in COVID–19 guidance Another guidance title referenced in COVID–19 guidance OMB control No(s).

Paperwork Reduction Act of 1995. This guidance refers to previously approved collections of information found in FDA regulations. These collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501– 3520). The collections of information in 21 CFR part 820 are approved under OMB control number 0910–0073; the collections of information in 21 CFR part 807, subpart E are approved under OMB control number 0910–0120; the collections of information in 21 CFR part 803 are approved under OMB control number 0910–0437; and the collections of information in 21 CFR parts 801 are approved under OMB control number 0910–0485.