Compliance Policy Guide Sec. 110.100; Withdrawal of Guidance, 61279 [2021-24234]

Download as PDF 61279 Federal Register / Vol. 86, No. 212 / Friday, November 5, 2021 / Notices drug products marketed outside the monograph system. In the Federal Register of June 30, 2021 (86 FR 34759), we published a 60- day notice requesting public comment on the proposed collection of information. No comments were received. We estimate the burden of this collection of information as follows: TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1 Number of respondents 21 CFR section or type of respondent and activity Number of responses per respondent Total annual responses Average burden per response Total hours 310.305(c)(5) ..................................................................................................... 314.80(c)(1)(iii) .................................................................................................. 314.80(c)(2) ....................................................................................................... Reports of serious adverse drug events (§ 329.100) ....................................... Applicants that have a PSUR waiver for an approved application .................. Applicants that do not have a PSUR waiver for an approved application ....... Notifying FDA when normal reporting is not feasible ....................................... 3 5 820 285 55 29 350 1 1 17.32 690 3.4 2.3 1 3 5 14,202 196,650 187 67 350 1 1 60 6 1 2 8 3 5 852,120 1,179,900 187 134 2,800 Total 2 ......................................................................................................... .......................... ........................ 211,464 .......................... 2,035,149 1 The capital costs or operating and maintenance costs associated with this collection of information are approximately $25,000 annually. TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1 Number of recordkeepers 21 CFR section or FD&C act section and activity 310.305 ............................................................................................................. 314.80(j) ............................................................................................................ Recordkeeping of nonprescription drug adverse event reports (Section 760(e)(1) of the FD&C Act) ........................................................................... Adding Adverse Event report planning to Continuity of Operations Plans ...... Maintaining documentation of pandemic conditions and resultant high absenteeism ............................................................................................................ Maintaining records to identify what reports have been stored and when the reporting process was restored ..................................................................... Total 2 ......................................................................................................... Number of records per recordkeeper Total annual records Average burden per recordkeeping Total hours 25 352 1 1,870 25 658,240 16 16 400 10,531,840 300 100 885.6667 1 265,700 100 8 50 2,125,600 5,000 350 1 350 8 2,800 350 1 350 8 2,800 .......................... ........................ 924,765 .......................... 12,668,440 1 There are no capital costs or operating costs associated with this collection of information. 2 There are maintenance costs of approximately $22,000 annually. We have increased our estimate to reflect expected adjustments to the information collection since our last submission for OMB review and approval. Sec. 110.100 contains information that is either duplicative of other information we have published or no longer reflects the Agency’s current thinking. Dated: November 1, 2021. Lauren K. Roth, Associate Commissioner for Policy. DATES: [FR Doc. 2021–24236 Filed 11–4–21; 8:45 am] Tiffany Kelley, Office of Regulatory Affairs, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993–0002, 301–348–1970, Tiffany.Kelley@fda.hhs.gov. SUPPLEMENTARY INFORMATION: FDA originally issued CPG Sec. 110.100 on October 1, 1980, in the Agency’s Manual of Compliance Policy Guides. The CPG was revised periodically but has not been revised since April 14, 2000. Since FDA last revised CPG Sec. 110.100, the Agency issued separate guidance for industry on FDA export certification in 2004. FDA revised that guidance in 2005, 2019, and, most recently, in August 2021. The August 2021 version of the guidance for industry, entitled ‘‘FDA Export Certification,’’ provides the Agency’s current guidance regarding FDA issuance of export certification. Persons with access to the internet may obtain The withdrawal is effective November 5, 2021. FOR FURTHER INFORMATION CONTACT: BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–1996–D–0405] Compliance Policy Guide Sec. 110.100; Withdrawal of Guidance AGENCY: Food and Drug Administration, HHS. jspears on DSK121TN23PROD with NOTICES1 ACTION: Notice; withdrawal. The Food and Drug Administration (FDA, the Agency, or we) is announcing the withdrawal of Compliance Policy Guide Sec. 110.100, ‘‘Certification for Exports’’ (CPG Sec. 110.100), which FDA issued in 1980. We are taking this action because CPG SUMMARY: VerDate Sep<11>2014 21:40 Nov 04, 2021 Jkt 256001 PO 00000 Frm 00167 Fmt 4703 Sfmt 4703 the guidance at https://www.fda.gov/ regulatory-information/search-fdaguidance-documents. Although this guidance originally complemented the content in CPG Sec. 110.100, changes in the document over time have increasingly resulted in CPG Sec. 110.100 containing duplicative and outdated information. Thus, FDA is withdrawing CPG Sec. 110.100 in its entirety. Dated: November 1, 2021. Lauren K. Roth, Associate Commissioner for Policy. [FR Doc. 2021–24234 Filed 11–4–21; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Assistant Secretary for Administration; Delegation of Authority Notice is hereby given that I have amended the delegation of authority to the Assistant Secretary for Preparedness and Response (ASPR); the Director, Centers for Disease Control and Prevention (CDC); the Administrator, Health Resources and Services Administration (HRSA); the Director, E:\FR\FM\05NON1.SGM 05NON1

Agencies

[Federal Register Volume 86, Number 212 (Friday, November 5, 2021)]
[Notices]
[Page 61279]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-24234]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-1996-D-0405]


Compliance Policy Guide Sec. 110.100; Withdrawal of Guidance

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; withdrawal.

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SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is 
announcing the withdrawal of Compliance Policy Guide Sec. 110.100, 
``Certification for Exports'' (CPG Sec. 110.100), which FDA issued in 
1980. We are taking this action because CPG Sec. 110.100 contains 
information that is either duplicative of other information we have 
published or no longer reflects the Agency's current thinking.

DATES: The withdrawal is effective November 5, 2021.

FOR FURTHER INFORMATION CONTACT: Tiffany Kelley, Office of Regulatory 
Affairs, Food and Drug Administration, 10903 New Hampshire Ave., Silver 
Spring, MD 20993-0002, 301-348-1970, [email protected].

SUPPLEMENTARY INFORMATION: FDA originally issued CPG Sec. 110.100 on 
October 1, 1980, in the Agency's Manual of Compliance Policy Guides. 
The CPG was revised periodically but has not been revised since April 
14, 2000.
    Since FDA last revised CPG Sec. 110.100, the Agency issued separate 
guidance for industry on FDA export certification in 2004. FDA revised 
that guidance in 2005, 2019, and, most recently, in August 2021. The 
August 2021 version of the guidance for industry, entitled ``FDA Export 
Certification,'' provides the Agency's current guidance regarding FDA 
issuance of export certification. Persons with access to the internet 
may obtain the guidance at https://www.fda.gov/regulatory-information/search-fda-guidance-documents. Although this guidance originally 
complemented the content in CPG Sec. 110.100, changes in the document 
over time have increasingly resulted in CPG Sec. 110.100 containing 
duplicative and outdated information. Thus, FDA is withdrawing CPG Sec. 
110.100 in its entirety.

    Dated: November 1, 2021.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2021-24234 Filed 11-4-21; 8:45 am]
BILLING CODE 4164-01-P

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