Source: https://www.federalregister.gov/documents/2019/03/04/2019-03824/agency-information-collection-activities-submission-for-office-of-management-and-budget-review
Timestamp: 2019-09-19 13:29:58
Document Index: 643682517

Matched Legal Cases: ['art 106', 'art 106', 'art 106', 'art 106', 'art 106', 'art 106']

Federal Register :: Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Exempt Infant Formula Production: Current Good Manufacturing Practices, Quality Control Procedures, Conduct of Audits, and Records
Fax written comments on the collection of information by April 3, 2019.
84 FR 7381
Docket No. FDA-2018-N-3490
2019-03824
Exempt Infant Formula Production: Current Good Manufacturing Practices (CGMPs), Quality Control Procedures, Conduct of Audits, and Records
OMB Control Number 0910-0811—Extension
https://www.federalregister.gov/d/2019-03824 https://www.federalregister.gov/d/2019-03824
To ensure that comments on the information collection are received, OMB recommends that written comments be faxed to the Office of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, Fax: 202-395-7285, or emailed to oira_submission@omb.eop.gov. All comments should be identified with the OMB control number 0910-0811. Also include the FDA docket number found Start Printed Page 7382in brackets in the heading of this document.
Section 412(h)(1) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 350a(h)(1)) exempts an infant formula that is represented and labeled for use by an infant with an inborn error of metabolism, low birth weight, or who otherwise has an unusual medical or dietary problem from the requirements of section 412(a)-(c) of the FD&C Act. These formulas are customarily referred to as “exempt infant formulas.” Under part 106 (21 CFR part 106), we established requirements for quality factors for infant formulas and CGMPs, including quality control procedures. This collection of information will help prevent the manufacture of adulterated infant formula, ensure the safety of infant formula, and ensure that the nutrients in infant formula are present in a form that is bioavailable.
In the Federal Register of April 15, 2016 (81 FR 22174), we published a notice of availability for the guidance document entitled “Guidance for Industry: Exempt Infant Formula Production: Current Good Manufacturing Practices (CGMPs), Quality Control Procedures, Conduct of Audits, and Records and Reports.” The guidance describes our current thinking on the manufacturing of exempt infant formula in relation to the requirements in part 106 for CGMPs, quality control procedures, conduct of audits, and records and reports that apply to nonexempt infant formulas. Persons with access to the internet may obtain the guidance at https://www.fda.gov/​FoodGuidances.
Our estimate of the burden of the recordkeeping recommendations includes the one-time burden of developing production and in-process control systems and the annual burdens of developing and maintaining aggregate production and control records, records pertaining to the distribution of infant formula, and records pertaining to regularly scheduled audits. Included in the burden estimate is the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing each collection of information.
The guidance recommended, to the extent practicable, that respondents include records required by part 106, subparts A, B, C, D, and F for non-exempt infant formulas. Because the records and reporting requirements related to part 106, subparts E and G are not generally applicable to exempt infant formula manufacturers, FDA is not recommending in the guidance that exempt infant formula manufacturers follow these requirements. As such, the records and reporting requirements in part 106, subparts E and G are not part of this information collection.
In the Federal Register of October 1, 2018 (83 FR 49393), we published a 60-day notice requesting public comment on the proposed collection of information. No comments were received.
First-Year Annual Burden:
Production and In-Process Control System—106.6(c)(5) and 106.100(e)(1), and (e)(3) 3 1 3 40 120
Controls to Prevent Adulteration due to Automatic (Mechanical or Electronic) Equipment—106.35(c) and 106.100(f)(5) 3 1 3 6,400 19,200
Recurring Annual Burden:
Controls to Prevent Adulteration Caused by Facilities—Testing for Radiological Contaminants—106.20(f)(3) 4 1 4 1.5 6
Controls to Prevent Adulteration Caused by Facilities—Recordkeeping of Testing for Radiological Contaminants—106.20(f)(4) and 106.100(f)(1) 4 1 4 0.08 (5 minutes) 0.32
Controls to Prevent Adulteration Caused by Facilities—Testing for Bacteriological Contaminants—106.20(f)(3) 3 52 156 0.08 (5 minutes) 12.48
Controls to Prevent Adulteration Caused by Facilities—Recordkeeping of Testing for Bacteriological Contaminants—106.20(f)(4) and 106.100(f)(1) 3 52 156 0.08 (5 minutes) 12.48
Controls to Prevent Adulteration by Equipment or Utensils—106.30(d)(1) and 106.100(f)(2) 3 52 156 0.21 (13 minutes) 32.76
Controls to Prevent Adulteration by Equipment or Utensils—106.30(e)(3)(iii) and 106.100(f)(3) 3 52 156 0.21 (13 minutes) 32.76
Controls to Prevent Adulteration by Equipment or Utensils—106.30(f)(2) and 106.100(f)(4) 3 52 156 0.19 (11 minutes) 29.64
Controls to Prevent Adulteration Due to Automatic (Mechanical or Electronic) Equipment—106.35(c) and 106.100(f)(5) 3 52 156 520 81,120
Controls to Prevent Adulteration Due to Automatic (Mechanical or Electronic) Equipment—106.35(c) and 106.100(f)(5) 3 2 6 640 3,840
Controls to Prevent Adulteration Caused by Ingredients, Containers, and Closures—106.40(g) and 106.100(f)(6) 3 52 156 0.17 (10 minutes) 26.52
Controls to Prevent Adulteration During Manufacturing—106.50 and 106.100(e) 3 52 156 0.23 (14 minutes) 35.88
Controls to Prevent Adulteration From Microorganisms—106.55(d), 106.100(e)(5)(ii), and 106.100(f)(7) 3 52 156 0.25 (15 minutes) 39
Controls to Prevent Adulteration During Packaging and Labeling of Infant Formula—106.60(c) 1 12 12 0.25 (15 minutes) 3
General Quality Control Testing—106.91(b)(1)-(3) 2 1 2 2 4
General Quality Control—106.91(b)(1), 106.91(d), and 106.100(e)(5)(i) 2 52 104 0.15 (9 minutes) 15.6
General Quality Control—106.91(b)(2), 106.91(d), and 106.100(e)(5)(i) 2 52 104 0.15 (9 minutes) 15.6
General Quality Control—106.91(b)(3), 106.91(d), and 106.100(e)(5)(i) 2 52 104 0.15 (9 minutes) 15.6
Audit Plans and Procedures—106.94; Ongoing Review and Updating of Audits 3 1 3 8 24
Audit Plans and Procedures—106.94; Regular Audits 3 52 156 4 624
Total Recurring Recordkeeping Burden 85,889.64
Total Recordkeeping Burden 105,209.64
Based on a review of the information collection, we made a correction since the last OMB approval. While the one-time estimated recordkeeping burden remains as 19,320 hours, we increased the annual estimated recurring recordkeeping burden to 85,889.64 hours due to a calculation error (a 79,561.58 hour increase) for a total recordkeeping burden of 105,209.64 hours.
[FR Doc. 2019-03824 Filed 3-1-19; 8:45 am]