80 FR 14134 - Agency Information Collection Activities; Proposed Collection; Comment Request; Recommended Recordkeeping for Exempt Infant Formula Production
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 80, Issue 52 (March 18, 2015)
Food and Drug Administration
Federal Register Volume 80, Issue 52 (March 18, 2015)
| Page Range | 14134-14138 | |
| FR Document | 2015-06117 |
[Federal Register Volume 80, Number 52 (Wednesday, March 18, 2015)] [Notices] [Pages 14134-14138] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-06117] ======================================================================= ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2014-D-0044] Agency Information Collection Activities; Proposed Collection; Comment Request; Recommended Recordkeeping for Exempt Infant Formula Production AGENCY: Food and Drug Administration, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA or we) is announcing an opportunity for public comment on our proposed collection of certain information. Under the Paperwork Reduction Act of 1995 (the PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information and to allow 60 days for public comment in response to the notice. This notice invites comments on the information collection provisions of the draft guidance entitled ``Draft Guidance for Industry: Exempt Infant Formula Production: Current Good Manufacturing Practices (CGMPs), Quality Control Procedures, Conduct of Audits, and Records and Reports.'' DATES: Submit either electronic or written comments on the collection of information by May 18, 2015. ADDRESSES: Submit electronic comments on the collection of information to http://www.regulations.gov. Submit written comments on the collection of information to the Division of Dockets Management (HFA- 305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. All comments should be identified with the docket number found in brackets in the heading of this document. FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations, Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver Spring, MD 20993-0002, [email protected]. SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal Agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. ``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes Agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal Agencies to provide a 60-day notice in the Federal Register concerning each proposed collection of information before submitting the collection to OMB for approval. To comply with this requirement, FDA is publishing notice of the proposed collection of information set forth in this document. With respect to the following collection of information, FDA invites comments on these topics: (1) Whether the proposed collection of information is necessary for the proper performance of FDA's functions, including whether the information will have practical utility; (2) the accuracy of FDA's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology. Recommended Recordkeeping for Exempt Infant Formula Production--OMB Control Number 0910--NEW I. Background Section 412(h)(1) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 350a(h)(1)) exempts an infant formula which 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), (b), and (c) of the FD&C Act. These formulas are customarily referred to as ``exempt infant formulas.'' In the Federal Register of June 10, 2014 (79 FR 33057), we published a final rule that adopted, with some modifications, an interim final rule published on February 10, 2014 (79 FR 7933), that established requirements for quality factors for infant formulas and current good manufacturing practices (CGMPs), including quality control procedures, under section 412 of the FD&C Act. The final rule 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 February 10, 2014 (79 FR 7610), we published a notice of availability of the draft 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 draft guidance). The draft guidance, when finalized, will describe our current thinking on the manufacturing of exempt infant formula in relation to the requirements in part 106 (21 CFR 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 draft guidance at http://www.fda.gov/FoodGuidances. II. Analysis of the Proposed Information Collection The proposed information collection seeks OMB approval of the recordkeeping recommendations of the draft guidance. 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 production 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. Description of Respondents: The respondent recordkeepers are manufacturers of exempt infant formula. Description: The records recommended, to the extent practicable, in the draft guidance 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 draft guidance that exempt infant formula manufacturers follow these [[Page 14135]] requirements. As such, the records and reporting requirements in part 106 subparts E and G are not part of this new information collection. FDA estimates the burden of this collection of information as follows: The total one-time estimated burden imposed by this collection of information is 19,320 hours. The total annual estimated burden imposed by this collection of information is 6,328.06 hours. There are no capital costs or operating and maintenance costs associated with this collection of information. The estimated burden for the draft guidance is based on ``Evaluation of Recordkeeping Costs for Food Manufacturers,'' Eastern Research Group Task Order No. 5, Contract No. 223-01-2461. FDA estimates that firms will be able to fulfill recordkeeping requirements with existing record systems; that is, FDA estimates that it will not be necessary for infant formula firms to invest in new recordkeeping systems. As of the beginning of 2015, five manufacturers produce exempt infant formulas that are marketed in the United States. Four out of these five infant formula manufacturers produce both exempt and non- exempt infant formulas, with both types of infant formula produced using the same production lines and equipment. Our experts believe that manufacturing practices are similar for both exempt and non-exempt infant formulas. Furthermore, given expert estimations of industry standard practices, it is estimated that the manufacturer that only produces exempt infant formula has practices comparable to those manufacturers producing both exempt and non-exempt infant formulas (Ref. 1). Together, these 5 manufacturers produce exempt infant formula at 12 plants. The number of recordkeepers in column 3 of table 1 is based on FDA's expert estimation of the number of plants that may not already be adhering to the relevant recordkeeping provisions of the final rule. The Regulatory Impact Analysis for the final rule (79 FR 33057) estimated that 25 percent of all infant formula plants manufacturing non-exempt infant formula were not currently adhering to the recordkeeping provisions under Sec. 106.100. Although such recordkeeping requirements are now effective for manufacturers of non- exempt infant formulas, and manufacturers of exempt infant formulas may have implemented similar procedures for their exempt infant formulas, it is estimated conservatively that this same proportion (25 percent, or 3 out of 12 plants that manufacture exempt infant formula) are not currently adhering to the recordkeeping provisions, and unless otherwise specified, burdens are estimated based on these 3 plants. Furthermore, we estimate that plants will collect the same information across the various exempt infant formulas produced by each firm. For records pertaining to production and in-process controls, FDA estimates that, at most, three plants do not currently develop production records as specified under Sec. Sec. 106.6(c)(5) and 106.100(e)(1) and (e)(3). A team of two senior validation engineers (or other similarly skilled employees) per plant (2 workers per plant x 3 plants = 6 workers) would each need to work 20 hours to provide sufficient initial baseline records and documentation to develop records pertaining to production and in-process controls, for an industry total of 120 hours (2 workers per plant x 3 plants x 20 hours per worker = 120 hours), as presented in line 1 of table 1. For the recordkeeping specified under Sec. 106.35(c), in accordance with Sec. 106.100(f)(5), FDA estimates that a team of 10 senior validation engineers (or other similarly skilled employees) per plant would need to work full time for 16 weeks (16 weeks/person x 40 work hours/week = 640 work hours per person) to provide sufficient initial records and documentation pertaining to controls intended to prevent adulteration due to automatic equipment. The total burden for 10 senior validation engineers each working 640 hours is 6,400 per plant in the first year (10 senior validation engineers x 640 hours = 6,400). For three plants, the total one-time hourly burden is 3 plants x 6,400 hours per plant = 19,200 hours, as presented in line 2 of table 1. For the testing specified under Sec. 106.20(f)(3), manufacturers of exempt infant formulas should conduct water testing with appropriate frequency to meet Environmental Protection Agency primary standards for drinking water (40 CFR parts 9, 141, and 142), but shall conduct these tests at least annually for chemical contaminants, every 4 years for radiological contaminants, and weekly for bacteriological contaminants. FDA estimates that it is part of normal business practice for exempt infant formula plants to test for chemical contaminants and keep records of those tests on a regular basis; therefore, this is a new collection of information that does not present a burden (Ref. 1). It is estimated that the recommendation to manufacturers of exempt infant formulas to test at least every 4 years for radiological contaminants would represent a new burden for all 12 infant formula plants (Ref. 1). In addition, it is estimated that collecting water for this testing takes between 1 and 2 hours (Ref. 1). For the purposes of this analysis, it is conservatively estimated that water collection takes, on average, 1.5 hours and that water collection occurs separately for each type of testing. It is estimated that performing the test (collecting the information) will take 1.5 hours per test, every 4 years. Therefore, 1.5 hours per plant x 12 plants = 18 total hours, every 4 years, or 4.5 hours per year, as seen in line 3 of table 1. Furthermore, the draft guidance recommends that manufacturers of exempt infant formula make and retain records of the frequency and results of water testing as specified under Sec. Sec. 106.20(f)(4) and 106.100(f)(1). For the 12 plants that are estimated not to currently test for radiological contaminants, this burden is estimated to be 5 minutes per record every 4 years. Therefore, 0.08 hour per record x 12 plants = 0.96 hour every 4 years for the maintenance of records of radiological testing, or 0.24 hours per year, as seen on line 4 of table 1. It is estimated that the recommendation to test weekly for bacteriological contaminants is a new burden for three infant formula plants. It is estimated that performing the test (collecting the information) will take 5 minutes per test once a week. Annually, this burden is 0.08 hour x 52 weeks = 4.16 hours per year per plant, and 4.16 hours per plant x 3 plants = 12.48 total annual hours, as seen on line 5 of table 1. Furthermore, for the three plants that are estimated to not currently test weekly for bacteriological contaminants, this burden is estimated to be 5 minutes per record, every week. Therefore, 0.08 hour per record x 52 weeks = 4.16 hours per plant for the maintenance of records of bacteriological testing. Accordingly, 4.16 hours per plant x 3 plants = 12.48 annual hours, as seen on line 6 of table 1. The draft guidance recommends that manufacturers of exempt infant formulas calibrate certain instruments against a known reference standard and that records of these calibration activities be made and retained, as specified in Sec. Sec. 106.30(d)(1) and 106.100(f)(2). FDA estimates that one senior validation engineer (or other similarly skilled employee) for each of the three (at most) plants would need to spend about 13 minutes per week to conduct the ongoing calibration recordkeeping. Therefore, 3 recordkeepers x 0.21 hours per week per [[Page 14136]] recordkeeper = 0.63 hours per week; 0.63 hours per week x 52 weeks per year = 32.76 hours as the total industry annual burden, as presented in line 7 of table 1. The draft guidance recommends that manufacturers of exempt infant formula make and retain records of the temperatures of each cold storage compartment as specified in Sec. Sec. 106.30(e)(3)(iii) and 106.100(f)(3). Based on expert opinion, FDA estimates that three (at most) plants are not currently conducting recordkeeping, and that at each of these three plants, conducting this recordkeeping would take one senior validation engineer (or other similarly skilled employee) about 13 minutes per week. Therefore, 3 recordkeepers x 0.21 hours per week per recordkeeper = 0.63 hours per week; 0.63 hours per week x 52 weeks = 32.76 hours as the total industry annual burden, as presented in line 8 of table 1. The draft guidance recommends the making and retention of records of ongoing sanitation efforts as specified under Sec. Sec. 106.30(f)(2) and 106.100(f)(4). Based on expert opinion, FDA estimates that three (at most) plants are not currently making and retaining these records, and that at each of these three plants, it would take one senior validation engineer (or other similarly skilled employee) 0.19 hours per week to make and retain these records. Therefore, 3 recordkeepers x 0.19 hours per week per recordkeeper = 0.57 hours per week; 0.57 hours per week x 52 weeks = 29.64 hours as the total industry annual burden, as presented in line 9 of table 1. There will be annual recordkeeping associated with recommendations for preventing adulteration from equipment, as specified under Sec. Sec. 106.35(c) and 106.100(f)(5). It is estimated that one senior validation engineer (or other similarly skilled employee) per plant would need to work 10 hours per week (520 work hours per year) to meet the ongoing recordkeeping recommendation. For the estimated three (at most) plants not conducting this recordkeeping, the total annual burden is 520 hours per plant x 3 plants = 1,560 annual hours, as shown in line 10 of table 1. In addition, this guidance recommends that an infant formula manufacturer revalidate its systems when it makes changes to automatic equipment. FDA estimates that such changes are likely to occur twice a year to any aspect of the plant's system, and that on each of the two occasions, a team of four senior validation engineers (or other similarly skilled employees) per plant would need to work full time for 4 weeks (4 weeks x 40 hours per week = 160 work hours per person) to provide revalidation of the plant's automated systems sufficient to adhere to this section. The total annual burden for four senior validation engineers each working 160 hours twice a year is 1,280 hours ((160 hours x 2 revalidations) x 4 engineers = 1,280 total work hours) per plant. Therefore, 1,280 hours per plant x 3 plants = 3,840 annual hours, as shown on line 11 of table 1. The draft guidance recommends written specifications for ingredients, containers, and closures, as specified under Sec. Sec. 106.40(g) and 106.100(f)(6). FDA estimates that the exempt infant formula industry already establishes written specifications for these components. However, the guidance regarding controls to prevent adulteration caused by ingredients, containers, and closures may represent new recordkeeping for three (at most) plants (Ref. 1). It is not possible to predict how often a specification will not be met or how often documented reviews of reconditioned ingredients, closures, or containers will occur. FDA estimates that, on average, one senior validation engineer per plant would work about 10 minutes a week to complete this recordkeeping. Therefore, 3 recordkeepers x 0.17 hours per week per recordkeeper = 0.51 hours per week; 0.51 hours per week x 52 weeks = 26.52 total annual hours, as presented in line 12 of table 1. This draft guidance recommends manufacturers of exempt infant formula to make and maintain records of controls to prevent adulteration during manufacturing, as specified in Sec. Sec. 106.50 and 106.100(e). It is not possible to predict how often changes to the master manufacturing order would be made or how often deviations from the master manufacturing order would occur. Based on expert opinion, FDA estimates that each year, three (at most) plants would change a master manufacturing order and that, on average, one senior validation engineer for each of the three (at most) plants would spend about 14 minutes per week on recordkeeping pertaining to the master manufacturing order. Thus, 3 recordkeepers x 0.23 hours per recordkeeper per week = 0.69 hours per week; 0.69 hours per week x 52 weeks = 35.88 hours as the total annual industry burden, as presented in line 13 of table 1. The draft guidance recommends manufacturers of exempt infant formula make and retain records of the testing of infant formula for microorganisms, as specified in Sec. Sec. 106.55(d) and 106.100(e)(5)(ii) and (f)(7). We estimate that this recordkeeping represents a new collection of information for, at most, three plants (Ref. 1) and that one senior validation engineer per plant would spend 15 minutes per week on recordkeeping pertaining to microbiological testing. Thus, 3 recordkeepers x 0.25 hours per recordkeeper per week = 0.75 hours; 0.75 hours per week x 52 weeks = 39 hours as the total annual industry burden, as presented in line 14 of table 1. The draft guidance recommends that exempt infant formula manufacturers make and maintain records consistent with the requirements for the labeling of mixed-lot packages of infant formula that apply to non-exempt infant formula manufacturers, as specified under Sec. 106.60(c). We estimate that the draft guidance will result in infant formula diverters labeling infant formula packaging (such as packing cases) to facilitate product tracing and to keep specific records of the distribution of these mixed lot cases. (A diverter is considered to be a business or individual that purchases food, including occasionally infant formula, in a geographic area where a special allowance or deal is being offered and then resells that food at a lower price to wholesale or retail grocery, drug and mass merchandise chains in an area where the deal is not being offered.) There will be some cost associated with this recordkeeping and labeling, but the Agency estimates that this burden would be minimal as it is estimated that less than 1 percent of infant formula is handled by diverters. For the purposes of this analysis, it is estimated that, for all plants combined, it may take one worker using manual methods 15 minutes, at most, to relabel one case of infant formula one time each month (0.25 hours per month x 12 months = 3 annual hours), as presented in line 15 of table 1. The draft guidance recommends nutrient testing for exempt infant formula manufacturers as specified in Sec. 106.91(a)(1) to (a)(4). It is estimated that the systems and processes of 100 percent of the exempt formula industry test in accordance with these provisions. Therefore, nutrient testing does not represent a new recordkeeping burden as nutrient testing is estimated to be common business practice in the exempt infant formula industry. Thus, no burden is estimated for these recommendations (Ref. 1). The draft guidance also recommends ongoing stability testing as specified under Sec. 106.91(b)(1), (b)(2), and (b)(3). It is estimated that the systems and processes of the infant formula industry [[Page 14137]] partially adhere to this guidance in that 80 percent of infant formula plants (about 10 of 12 plants) conduct stability testing as recommended (Ref. 1). For the 20 percent of plants (2 of 12 plants) that do not conduct stability testing, it is estimated that these plants do conduct initial stability testing, but may not do so at the intervals specified in this provision (Ref. 1). For the purposes of this analysis, it is estimated that the stability testing guidance represents a new information collection burden of 2 annual hours, per plant. Therefore, 2 hours per plant x 2 plants = 4 annual hours as shown in line 16 of table 1. The draft guidance recommends recordkeeping for test results as specified under Sec. Sec. 106.91(d) and 106.100(e)(5)(i). This represents new information collections for the two plants that are estimated not to be conducting all of the stability testing specified in Sec. 106.91(b) (Ref. 1). For the purposes of this analysis, FDA estimates that one senior validation engineer per plant would spend about 9 minutes per week maintaining records related to testing. Thus, 2 recordkeepers x 0.15 hours per recordkeeper per week = 0.3 hours per week x 52 weeks = 15.6 hours as the annual total industry burden, as presented in lines 17, 18, and 19 of table 1. The draft guidance recommends the creation of audit plans and procedures, as specified under Sec. 106.94. FDA estimates that all exempt infant formula manufacturers currently conduct audits, but that 25 percent of infant formula plants (3 of 12 plants) do not conduct audits that include all elements specified in Sec. 106.94 (Ref. 1). It is estimated that the ongoing review and updating of audit plans would require a senior validation engineer 8 hours per year, per plant. Therefore, 8 hours per year per plant x 3 plants = 24 annual hours to regularly review and update audit plans as shown in line 20 of table 1. The infant formula final rule does not mandate a frequency of auditing, and, therefore, one is not recommended in the draft guidance. For the purposes of this analysis, FDA estimates that a manufacturer would choose to audit once per week. Each weekly audit is estimated to require a senior validation engineer 4 hours, or 52 weeks x 4 hours = 208 hours per plant per year. Therefore, the total annual burden for the estimated three plants not currently acting in accordance to this guidance to update audit plans is 208 hours x 3 plants = 624 hours, as shown in line 21 of table 1. Table 1--Estimated Hourly Recordkeeping Burden ---------------------------------------------------------------------------------------------------------------- First year 21 CFR Section Number of frequency of Total Hours per Total recordkeepers recordkeeping records record hours ---------------------------------------------------------------------------------------------------------------- First Year Hourly Burden ---------------------------------------------------------------------------------------------------------------- 1........................... Production and 6 1 3 40 120 In-Process Control System 106.6(c)(5) and 106.100(e)(1) and (e)(3). 2........................... Controls to 30 1 3 6,400 19,200 Prevent Adulteration due to Automatic (mechanical or electronic) Equipment 106.35(c) and 106.100(f)(5). ------------------------------------------------------------------ Total First ............... ............... ......... ......... 19,320 Year Only Hourly Recordkeeping Burden. ---------------------------------------------------------------------------------------------------------------- Recurring Annual Hourly Burden ---------------------------------------------------------------------------------------------------------------- 3........................... Controls to 12 1 12 1.5 4.5 Prevent Adulteration Caused by Facilities--Te sting for Radiological Contaminants \1\ 106.20(f)(3). 4........................... Controls to 12 1 12 0.08 0.24 Prevent Adulteration Caused by Facilities--Re cordkeeping of Testing for Radiological Contaminants \2\ 106.20(f)(4) and 106.100(f)(1). 5........................... Controls to 3 52 156 0.08 12.48 Prevent Adulteration Caused by Facilities--Te sting for Bacteriologica l Contaminants 106.20(f)(3). 6........................... Controls to 3 52 156 0.08 12.48 Prevent Adulteration Caused by Facilities--Re cordkeeping of Testing for Bacteriologica l Contaminants 106.20(f)(4) and 106.100(f)(1). 7........................... Controls to 3 52 156 0.21 32.76 Prevent Adulteration by Equipment or Utensils 106.30(d)(1) and 106.100(f)(2). 8........................... Controls to 3 52 156 0.21 32.76 Prevent Adulteration by Equipment or Utensils 106.30(e)(3)(i ii) and 106.100(f)(3). 9........................... Controls to 3 52 156 0.19 29.64 Prevent Adulteration by Equipment or Utensils 106.30(f)(2) and 106.100(f)(4). 10.......................... Controls to 3 52 3 520 1,560 Prevent Adulteration Due to Automatic (Mechanical or Electronic) Equipment 106.35(c) and 106.100(f)(5). 11.......................... Controls to 12 2 6 640 3,840 Prevent Adulteration Due to Automatic (Mechanical or Electronic) Equipment 106.35(c) and 106.100(f)(5). 12.......................... Controls to 3 52 156 0.17 26.52 Prevent Adulteration Caused by Ingredients, Containers, and Closures 106.40(g) and 106.100(f)(6). 13.......................... Controls to 3 52 156 0.23 35.88 Prevent Adulteration During Manufacturing 106.50 and 106.100(e). [[Page 14138]] 14.......................... Controls to 3 52 156 0.25 39 Prevent Adulteration From Microorganisms 106.55(d), 106.100(e)(5)( ii), and 106.100(f)(7). 15.......................... Controls to 1 12 12 0.25 3 Prevent Adulteration During Packaging and Labeling of Infant Formula 106.60(c). 16.......................... General Quality 2 1 2 2 4 Control--Testi ng 106.91(b)(1), 106.91(b)(2) and 106.91(b)(3). 17.......................... General Quality 2 52 104 0.15 15.6 Control 106.91(b)(1), 106.91(d), and 106.100(e)(5)( i). 18.......................... General Quality 2 52 104 0.15 15.6 Control 106.91(b)(2) 106.91(d), and 106.100(e)(5)( i). 19.......................... General Quality 2 52 104 0.15 15.6 Control 106.91(b)(3) 106.91(d), and 106.100(e)(5)( i). 20.......................... Audit Plans and 3 1 3 8 24 Procedures 106.94--Ongoin g review and updating of Audits. 21.......................... Audit Plans and 3 52 156 4 624 Procedures 106.94--Regula r Audits. ------------------------------------------------------------------ Total Recurring ............... ............... ......... ......... 6,328.06 Recordkeeping Burden. ------------------------------------------------------------------ Total ............... ............... ......... ......... 25,648.06 Recordkeeping Burden. ---------------------------------------------------------------------------------------------------------------- \1\ As noted previously in the document, the burden for making and maintaining such records is expected to occur once every 4 years. The total hours column reflects the total number of hours averaged over the 4-year period. \2\ As noted previously in the document, the burden for making and maintaining such records is expected to occur once every 4 years. The total hours column reflects the total number of hours averaged over the 4-year period. III. References The following references have been placed on display in the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852, and may be seen by interested persons between 9 a.m. and 4 p.m., Monday through Friday. 1. Zink, Don. Statement of Donald L. Zink, Ph.D.: Infant Formula Manufacturing Practices, 2013. Dated: March 12, 2015. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2015-06117 Filed 3-17-15; 8:45 am] BILLING CODE 4164-01-P
![14134 Federal Register / Vol. 80, No. 52 / Wednesday, March 18, 2015 / Notices
1. FNBK Holdings, Inc., Dallas, Texas; Spring, MD 20993–0002, PRAStaff@ manufacturing practices (CGMPs),
to become a bank holding company by fda.hhs.gov. including quality control procedures,
acquiring 100 percent of the voting SUPPLEMENTARY INFORMATION: Under the under section 412 of the FD&C Act. The
shares of The First National Bank of PRA (44 U.S.C. 3501–3520), Federal final rule will help prevent the
Kemp, Kemp, Texas. Agencies must obtain approval from the manufacture of adulterated infant
Board of Governors of the Federal Reserve Office of Management and Budget formula, ensure the safety of infant
System, March 13, 2015. (OMB) for each collection of formula, and ensure that the nutrients in
Michael J. Lewandowski, information they conduct or sponsor. infant formula are present in a form that
‘‘Collection of information’’ is defined is bioavailable.
Associate Secretary of the Board.
in 44 U.S.C. 3502(3) and 5 CFR In the Federal Register of February
[FR Doc. 2015–06196 Filed 3–17–15; 8:45 am] 10, 2014 (79 FR 7610), we published a
1320.3(c) and includes Agency requests
BILLING CODE 6210–01–P
or requirements that members of the notice of availability of the draft
public submit reports, keep records, or guidance document entitled ‘‘Guidance
provide information to a third party. for Industry: Exempt Infant Formula
DEPARTMENT OF HEALTH AND Section 3506(c)(2)(A) of the PRA (44 Production: Current Good
HUMAN SERVICES U.S.C. 3506(c)(2)(A)) requires Federal Manufacturing Practices (CGMPs),
Agencies to provide a 60-day notice in Quality Control Procedures, Conduct of
Food and Drug Administration Audits, and Records and Reports’’ (the
the Federal Register concerning each
proposed collection of information draft guidance). The draft guidance,
[Docket No. FDA–2014–D–0044]
before submitting the collection to OMB when finalized, will describe our
Agency Information Collection for approval. To comply with this current thinking on the manufacturing
Activities; Proposed Collection; requirement, FDA is publishing notice of exempt infant formula in relation to
Comment Request; Recommended of the proposed collection of the requirements in part 106 (21 CFR
Recordkeeping for Exempt Infant information set forth in this document. part 106) for CGMPs, quality control
Formula Production With respect to the following procedures, conduct of audits, and
collection of information, FDA invites records and reports that apply to
AGENCY: Food and Drug Administration, comments on these topics: (1) Whether nonexempt infant formulas. Persons
HHS. the proposed collection of information with access to the Internet may obtain
ACTION: Notice. is necessary for the proper performance the draft guidance at http://
of FDA’s functions, including whether www.fda.gov/FoodGuidances.
SUMMARY: The Food and Drug the information will have practical II. Analysis of the Proposed
Administration (FDA or we) is utility; (2) the accuracy of FDA’s Information Collection
announcing an opportunity for public estimate of the burden of the proposed
comment on our proposed collection of The proposed information collection
collection of information, including the seeks OMB approval of the
certain information. Under the validity of the methodology and
Paperwork Reduction Act of 1995 (the recordkeeping recommendations of the
assumptions used; (3) ways to enhance draft guidance. Our estimate of the
PRA), Federal Agencies are required to the quality, utility, and clarity of the
publish notice in the Federal Register burden of the recordkeeping
information to be collected; and (4) recommendations includes the one-time
concerning each proposed collection of ways to minimize the burden of the
information and to allow 60 days for burden of developing production and
collection of information on in-process control systems and the
public comment in response to the respondents, including through the use
notice. This notice invites comments on annual burdens of developing and
of automated collection techniques, maintaining production aggregate
the information collection provisions of when appropriate, and other forms of
the draft guidance entitled ‘‘Draft production and control records, records
information technology. pertaining to the distribution of infant
Guidance for Industry: Exempt Infant
Formula Production: Current Good Recommended Recordkeeping for formula, and records pertaining to
Manufacturing Practices (CGMPs), Exempt Infant Formula Production— regularly scheduled audits. Included in
Quality Control Procedures, Conduct of OMB Control Number 0910—NEW the burden estimate is the time for
Audits, and Records and Reports.’’ reviewing instructions, searching
I. Background
DATES: Submit either electronic or
existing data sources, gathering and
Section 412(h)(1) of the Federal Food, maintaining the data needed, and
written comments on the collection of Drug, and Cosmetic Act (the FD&C Act)
information by May 18, 2015. completing and reviewing each
(21 U.S.C. 350a(h)(1)) exempts an infant collection of information.
ADDRESSES: Submit electronic formula which is represented and Description of Respondents: The
comments on the collection of labeled for use by an infant with an respondent recordkeepers are
information to http:// inborn error of metabolism, low birth manufacturers of exempt infant formula.
www.regulations.gov. Submit written weight, or who otherwise has an Description: The records
comments on the collection of unusual medical or dietary problem recommended, to the extent practicable,
information to the Division of Dockets from the requirements of section 412(a), in the draft guidance include records
Management (HFA–305), Food and Drug (b), and (c) of the FD&C Act. These required by part 106, subparts A, B, C,
Administration, 5630 Fishers Lane, Rm. formulas are customarily referred to as D, and F for non-exempt infant
1061, Rockville, MD 20852. All
mstockstill on DSK4VPTVN1PROD with NOTICES
‘‘exempt infant formulas.’’ In the formulas. Because the records and
comments should be identified with the Federal Register of June 10, 2014 (79 FR reporting requirements related to part
docket number found in brackets in the 33057), we published a final rule that 106 subparts E and G are not generally
heading of this document. adopted, with some modifications, an applicable to exempt infant formula
FOR FURTHER INFORMATION CONTACT: FDA interim final rule published on February manufacturers, FDA is not
PRA Staff, Office of Operations, Food 10, 2014 (79 FR 7933), that established recommending in the draft guidance
and Drug Administration, 8455 requirements for quality factors for that exempt infant formula
Colesville Rd., COLE–14526, Silver infant formulas and current good manufacturers follow these
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![14138 Federal Register / Vol. 80, No. 52 / Wednesday, March 18, 2015 / Notices
TABLE 1—ESTIMATED HOURLY RECORDKEEPING BURDEN—Continued
First year
Number of Total Hours per Total
21 CFR Section frequency of
recordkeepers records record hours
recordkeeping
14 ...................... Controls to Prevent Adulteration From Microorga- 3 52 156 0.25 39
nisms 106.55(d), 106.100(e)(5)(ii), and
106.100(f)(7).
15 ...................... Controls to Prevent Adulteration During Packaging 1 12 12 0.25 3
and Labeling of Infant Formula 106.60(c).
16 ...................... General Quality Control—Testing 106.91(b)(1), 2 1 2 2 4
106.91(b)(2) and 106.91(b)(3).
17 ...................... General Quality Control 106.91(b)(1), 106.91(d), 2 52 104 0.15 15.6
and 106.100(e)(5)(i).
18 ...................... General Quality Control 106.91(b)(2) 106.91(d), 2 52 104 0.15 15.6
and 106.100(e)(5)(i).
19 ...................... General Quality Control 106.91(b)(3) 106.91(d), 2 52 104 0.15 15.6
and 106.100(e)(5)(i).
20 ...................... Audit Plans and Procedures 106.94—Ongoing re- 3 1 3 8 24
view and updating of Audits.
21 ...................... Audit Plans and Procedures 106.94—Regular Au- 3 52 156 4 624
dits.
Total Recurring Recordkeeping Burden ................... .......................... .......................... ................ ................ 6,328.06
Total Recordkeeping Burden ................................... .......................... .......................... ................ ................ 25,648.06
1 Asnoted previously in the document, the burden for making and maintaining such records is expected to occur once every 4 years. The total
hours column reflects the total number of hours averaged over the 4-year period.
2 As noted previously in the document, the burden for making and maintaining such records is expected to occur once every 4 years. The total
hours column reflects the total number of hours averaged over the 4-year period.
III. References information by the Agency. Under the information they conduct or sponsor.
The following references have been Paperwork Reduction Act of 1995 (the ‘‘Collection of information’’ is defined
placed on display in the Division of PRA), Federal Agencies are required to in 44 U.S.C. 3502(3) and 5 CFR
Dockets Management (HFA–305), Food publish notice in the Federal Register 1320.3(c) and includes Agency requests
and Drug Administration, 5630 Fishers concerning each proposed collection of or requirements that members of the
Lane, rm. 1061, Rockville, MD 20852, information, including each proposed public submit reports, keep records, or
and may be seen by interested persons extension of an existing collection of provide information to a third party.
between 9 a.m. and 4 p.m., Monday information, and to allow 60 days for Section 3506(c)(2)(A) of the PRA (44
through Friday. public comment in response to the U.S.C. 3506(c)(2)(A)) requires Federal
notice. This notice solicits comments on Agencies to provide a 60-day notice in
1. Zink, Don. Statement of Donald L. Zink, the Emergency Shortages Data
Ph.D.: Infant Formula Manufacturing the Federal Register concerning each
Collection System. proposed collection of information,
Practices, 2013.
DATES: Submit either electronic or including each proposed extension of an
Dated: March 12, 2015. written comments on the collection of existing collection of information,
Leslie Kux, information by May 18, 2015. before submitting the collection to OMB
Associate Commissioner for Policy. ADDRESSES: Submit electronic for approval. To comply with this
[FR Doc. 2015–06117 Filed 3–17–15; 8:45 am] comments on the collection of requirement, FDA is publishing notice
BILLING CODE 4164–01–P information to http:// of the proposed collection of
www.regulations.gov. Submit written
information set forth in this document.
comments on the collection of
DEPARTMENT OF HEALTH AND information to the Division of Dockets With respect to the following
HUMAN SERVICES Management (HFA–305), Food and Drug collection of information, FDA invites
Administration, 5630 Fishers Lane, Rm. comments on these topics: (1) Whether
Food and Drug Administration 1061, Rockville, MD 20852. All the proposed collection of information
[Docket No. FDA–2012–N–0197] comments should be identified with the is necessary for the proper performance
docket number found in brackets in the of FDA’s functions, including whether
Agency Information Collection heading of this document. the information will have practical
Activities; Proposed Collection; FOR FURTHER INFORMATION CONTACT: FDA utility; (2) the accuracy of FDA’s
Comment Request; Emergency PRA Staff, Office of Operations, Food estimate of the burden of the proposed
Shortages Data Collection System and Drug Administration, 8455 collection of information, including the
Colesville Rd., COLE–14526, Silver validity of the methodology and
mstockstill on DSK4VPTVN1PROD with NOTICES
AGENCY: Food and Drug Administration,
Spring, MD 20993–0002, PRAStaff@ assumptions used; (3) ways to enhance
HHS.
fda.hhs.gov. the quality, utility, and clarity of the
ACTION: Notice.
SUPPLEMENTARY INFORMATION: Under the information to be collected; and (4)
SUMMARY: The Food and Drug PRA (44 U.S.C. 3501–3520), Federal ways to minimize the burden of the
Administration (FDA) is announcing an Agencies must obtain approval from the collection of information on
opportunity for public comment on the Office of Management and Budget respondents, including through the use
proposed collection of certain (OMB) for each collection of of automated collection techniques,
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Document Created: 2018-02-21 09:39:33
Document Modified: 2018-02-21 09:39:33
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice. | |
| Dates | Submit either electronic or written comments on the collection of information by May 18, 2015. | |
| Contact | FDA PRA Staff, Office of Operations, Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver Spring, MD 20993-0002, [email protected] | |
| FR Citation | 80 FR 14134 |
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