Source: https://www.federalregister.gov/documents/2016/11/21/2016-27943/agency-information-collection-activities-submission-for-office-of-management-and-budget-review
Timestamp: 2018-04-21 15:45:00
Document Index: 507757449

Matched Legal Cases: ['§\u200925', '§\u200925', '§\u200925', '§\u200925', '§\u200925', '§\u200925', 'art 25']

Fax written comments on the collection of information by December 21, 2016.
83245-83246 (2 pages)
https://www.federalregister.gov/d/2016-27943 https://www.federalregister.gov/d/2016-27943
The guidance provides information to assist in the preparation of claims of categorical exclusion and EAs for submission to CFSAN. The following questions are covered in this guidance: (1) What types of industry-initiated actions are subject to a claim of categorical exclusion? (2) What must a claim of categorical exclusion include by regulation? (3) What is an EA? (4) When is an EA required by regulation and what format should be used? (5) What are extraordinary circumstances? and (6) What suggestions does CFSAN have for preparing an EA? Although CFSAN encourages industry to use the EA formats described in the guidance because standardized documentation submitted by industry increases the efficiency of the review process, alternative approaches may be used if these approaches satisfy the requirements of the applicable statutes and regulations. We are requesting the extension of OMB approval for the Start Printed Page 83246information collection provisions in the guidance.
In the Federal Register of August 25, 2016 (81 FR 58517), FDA published a 60-day notice requesting public comment on the proposed collection of information. No comments were received.
25.15 (a) & (d) (to cover CEs under 25.32(i)) 47 1 47 8 376
25.15 (a) &(d) (to cover CEs under 25.32(o)) 1 1 1 8 8
25.15 (a) &(d) (to cover CEs under 25.32(q)) 3 1 3 8 24
25.40 (a) & (c) EAs 57 1 57 180 10,260
The estimates for respondents and numbers of responses are based on the annualized numbers of petitions and notifications qualifying for categorical exclusions listed under § 25.32(i) and (q) that the Agency has received in the past 3 years. Please note that, in the past 3 years, there have been no submissions that requested an action that would have been subject to the categorical exclusion in § 25.32(o). To avoid counting this burden as zero, we have estimated the burden for this categorical exclusion at one respondent making one submission a year for a total of one annual submission. The burden for submitting a categorical exclusion is captured under § 25.15(a) and (d).
To calculate the estimate for the hours per response values, we assumed that the information requested in this guidance for each of these three categorical exclusions is readily available to the submitter. For the information requested for the exclusion in § 25.32(i), we expect that submitter will need to gather information from appropriate persons in the submitter's company and prepare this information for attachment to the claim for categorical exclusion. We believe that this effort should take no longer than 8 hours per submission. For the information requested for the categorical exclusions in § 25.32(o) and (q), the submitters will almost always merely need to copy existing documentation and attach it to the claim for categorical exclusion. We believe that collecting this information should also take no longer than 8 hours per submission.
For the information requested for the environmental assessments in § 25.40(a) and (c), we believe that submitters will submit an average of 57 environmental assessments annually. We estimate that each submitter will prepare an EA within 3 weeks (120 hours) and revise the EA based on Agency comments (between 40 to 60 hours), for a total preparation time of 180 hours. The burden relating to this collection has been previously approved under OMB control number 0910-0322, “Environmental Impact Consideration—21 CFR part 25”. Upon approval of this collection of information by OMB, FDA will revise OMB control number 0910-0322 to remove the annual reporting burden for categorical exclusions and environmental assessment requests related to food additive petitions, color additive petitions, requests for exemption from regulation as a food additive, and submission of a food contact notification for a food contact substance. The future burden for categorical exclusion or environmental assessments for these requests will be captured under OMB control number 0910-0541, this collection of information.
[FR Doc. 2016-27943 Filed 11-18-16; 8:45 am]