Agency Information Collection Activities; Proposed Collection; Comment Request; Current Good Manufacturing Practice Regulations for Finished Pharmaceuticals, 58811-58815 [2017-26932]

Download as PDF Federal Register / Vol. 82, No. 239 / Thursday, December 14, 2017 / Notices DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2011–N–0362] Agency Information Collection Activities; Proposed Collection; Comment Request; Current Good Manufacturing Practice Regulations for Finished Pharmaceuticals AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the information collection for the Current Good Manufacturing Practice Regulations for Finished Pharmaceuticals. DATES: Submit either electronic or written comments on the collection of information by February 12, 2018. ADDRESSES: You may submit comments as follows. Please note that late, untimely filed comments will not be considered. Electronic comments must be submitted on or before February 12, 2018. The https://www.regulations.gov electronic filing system will accept comments until midnight Eastern Time at the end of February 12, 2018. Comments received by mail/hand delivery/courier (for written/paper submissions) will be considered timely if they are postmarked or the delivery service acceptance receipt is on or before that date. sradovich on DSK3GMQ082PROD with NOTICES SUMMARY: Electronic Submissions Submit electronic comments in the following way: • Federal eRulemaking Portal: https://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to https:// www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or VerDate Sep<11>2014 21:28 Dec 13, 2017 Jkt 244001 anyone else’s Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on https://www.regulations.gov. • If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see ‘‘Written/Paper Submissions’’ and ‘‘Instructions’’). Written/Paper Submissions Submit written/paper submissions as follows: • Mail/Hand delivery/Courier (for written/paper submissions): Dockets Management Staff (HFA–305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. • For written/paper comments submitted to the Dockets Management Staff, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in ‘‘Instructions.’’ Instructions: All submissions received must include the Docket No. FDA– 2011–N–0362 for ‘‘Current Good Manufacturing Practice Regulations for Finished Pharmaceuticals.’’ Received comments, those filed in a timely manner (see ADDRESSES), will be placed in the docket and, except for those submitted as ‘‘Confidential Submissions,’’ publicly viewable at https://www.regulations.gov or at the Dockets Management Staff office between 9 a.m. and 4 p.m., Monday through Friday. • Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states ‘‘THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.’’ The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on https://www.regulations.gov. Submit both copies to the Dockets Management Staff. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not PO 00000 Frm 00020 Fmt 4703 Sfmt 4703 58811 in the body of your comments and you must identify this information as ‘‘confidential.’’ Any information marked as ‘‘confidential’’ will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA’s posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: https://www.gpo.gov/ fdsys/pkg/FR-2015-09-18/pdf/201523389.pdf. Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to https:// www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the ‘‘Search’’ box and follow the prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. FOR FURTHER INFORMATION CONTACT: Domini Bean, Office of Operations, Food and Drug Administration, Three White Flint North, 10–12M, 11601 Landsdown St., North Bethesda, MD 20852, 301–796–5733, PRAStaff@ fda.hhs.gov. 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, including each proposed extension of an existing 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) E:\FR\FM\14DEN1.SGM 14DEN1 58812 Federal Register / Vol. 82, No. 239 / Thursday, December 14, 2017 / Notices 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. sradovich on DSK3GMQ082PROD with NOTICES Current Good Manufacturing Practice Regulations for Finished Pharmaceuticals (21 CFR Parts 210 and 211) OMB Control Number 0910–0139— Extension This information collection supports FDA regulations. Specifically, under section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 351(a)(2)(B)), a drug is adulterated if the methods used in or the facilities or controls used for its manufacture, processing, packing, or holding do not conform to or are not operated or administered in conformity with Current Good Manufacturing Practice (CGMP). The CGMP regulations help ensure drug products meet the statutory requirements for safety and have their purported or represented identity, strength, quality, and purity characteristics. The information collection requirements in the CGMP regulations provide FDA with the necessary information to perform its duty to protect public health and safety. CGMP requirements establish accountability for manufacturing and processing drug products, provide for meaningful FDA inspections, and enable manufacturers to improve the quality of drug products over time. The CGMP recordkeeping requirements also serve preventive and remedial purposes and provide crucial information if it is necessary to recall a drug product. The general requirements for recordkeeping under part 211 (21 CFR part 211) are set forth in § 211.180. Any production, control, or distribution record associated with a batch and required to be maintained in compliance with part 211 must be retained for at least 1 year after the expiration date of the batch and, for certain over-the-counter (OTC) drugs, 3 years after distribution of the batch (§ 211.180(a)). Records for all components, drug product containers, closures, and labeling are required to be maintained for at least 1 year after the expiration date and 3 years for certain OTC products (§ 211.180(b)). All part 211 records must be readily available for authorized inspections during the retention period (§ 211.180(c)), and such records may be retained either as original records or as true copies (§ 211.180(d)). Additionally, § 11.2(a) (21 CFR 11.2(a)) provides that VerDate Sep<11>2014 21:28 Dec 13, 2017 Jkt 244001 ‘‘for records required to be maintained but not submitted to the Agency, persons may use electronic records in lieu of paper records or electronic signatures in lieu of traditional signatures, in whole or in part, provided that the requirements of this part are met.’’ To the extent this electronic option is used, the burden of maintaining paper records should be substantially reduced, as should any review of such records. To facilitate improvements and corrective actions, records must be maintained so data can be used to evaluate the quality standards of each drug product on at least an annual basis and determine whether to change any drug product specifications or manufacturing or control procedures (§ 211.180(e)). Written procedures for these evaluations are to be established and include provisions for a review of a representative number of batches and, where applicable, records associated with the batch; provisions for a review of complaints, recalls, returned or salvaged drug products; and investigations conducted under § 211.192 for each drug product. The specific information collection provisions are as follows: • Section 211.34—Consultants advising on the manufacture, processing, packing, or holding of drug products must have sufficient education, training, and experience to advise on the subject for which they are retained. Records must be maintained stating the name, address, and qualifications of any consultants and the type of service they provide. • Section 211.67(c)—Records must be kept of maintenance, cleaning, sanitizing, and inspection as specified in §§ 211.180 and 211.182. • Section 211.68—Appropriate controls must be exercised over computer or related systems to assure that changes in master production and control records or other records are instituted only by authorized personnel. • Section 211.68(a)—Records must be maintained of calibration checks, inspections, and computer or related system programs for automatic, mechanical, and electronic equipment. • Section 211.68(b)—All appropriate controls must be exercised over all computers or related systems and control data systems to assure that changes in master production and control records or other records are instituted only by authorized persons. • Section 211.72—Filters for liquid filtration used in the manufacture, processing, or packing of injectable drug products intended for human use must not release fibers into such products. PO 00000 Frm 00021 Fmt 4703 Sfmt 4703 • Section 211.80(d)—Each container or grouping of containers for components or drug product containers or closures must be identified with a distinctive code for each lot in each shipment received. This code must be used in recording the disposition of each lot. Each lot must be appropriately identified as to its status. • Section 211.100(b)—Written production and process control procedures must be followed in the execution of the various production and process control functions and must be documented at the time of performance. Any deviation from the written procedures must be recorded and justified. • Section 211.105(b)—Major equipment must be identified by a distinctive identification number or code that must be recorded in the batch production record to show the specific equipment used in the manufacture of each batch of a drug product. In cases where only one of a particular type of equipment exists in a manufacturing facility, the name of the equipment may be used in lieu of a distinctive identification number or code. • Section 211.122(c)—Records must be maintained for each shipment received of each different labeling and packaging material indicating receipt, examination, or testing. • Section 211.130(e)—Inspection of packaging and labeling facilities must be made immediately before use to assure that all drug products have been removed from previous operations. Inspection must also be made to assure that packaging and labeling materials not suitable for subsequent operations have been removed. Results of inspection must be documented in the batch production records. • Section 211.132(c)—Certain retail packages of OTC drug products must bear a statement that is prominently placed so consumers are alerted to the specific tamper-evident feature of the package. The labeling statement is required to be so placed that it will be unaffected if the tamper-resistant feature of the package is breached or missing. If the tamper-evident feature chosen is one that uses an identifying characteristic, that characteristic is required to be referred to in the labeling statement. • Section 211.132(d)—A request for an exemption from packaging and labeling requirements by a manufacturer or packer is required to be submitted in the form of a citizen petition under 21 CFR 10.30. • Section 211.137—Requirements regarding product expiration dating and compliance with 21 CFR 201.17. E:\FR\FM\14DEN1.SGM 14DEN1 sradovich on DSK3GMQ082PROD with NOTICES Federal Register / Vol. 82, No. 239 / Thursday, December 14, 2017 / Notices • Section 211.160(a)—The establishment of any specifications, standards, sampling plans, test procedures, or other laboratory control mechanisms, including any change in such specifications, standards, sampling plans, test procedures, or other laboratory control mechanisms, must be drafted by the appropriate organizational unit and reviewed and approved by the quality control unit. These requirements must be followed and documented at the time of performance. Any deviation from the written specifications, standards, sampling plans, test procedures, or other laboratory control mechanisms must be recorded and justified. • Section 211.165(e)—The accuracy, sensitivity, specificity, and reproducibility of test methods employed by a firm must be established and documented. Such validation and documentation may be accomplished in accordance with § 211.194(a)(2). • Section 211.166—Stability testing program for drug products. • Section 211.173—Animals used in testing components, in-process materials, or drug products for compliance with established specifications must be maintained and controlled in a manner that assures their suitability for their intended use. They must be identified, and adequate records must be maintained showing the history of their use. • Section 211.180(e)—Written records required by part 211 must be maintained so that data can be used for evaluating, at least annually, the quality standards of each drug product to determine the need for changes in drug product specifications or manufacturing or control procedures. Written procedures must be established and followed for such evaluations and must include provisions for a representative number of batches, whether approved or unapproved or rejected, and a review of complaints, recalls, returned or salvaged drug products, and investigations conducted under § 211.192 for each drug product. • Section 211.180(f)—Procedures must be established to assure that the responsible officials of the firm, if they are not personally involved in or immediately aware of such actions, are notified in writing of any investigations, conducted under § 211.198, § 211.204, or § 211.208, any recalls, reports of inspectional observations issued, or any regulatory actions relating to good manufacturing practices brought by FDA. • Section 211.182—Specifies requirements for equipment cleaning records and the use log. VerDate Sep<11>2014 21:28 Dec 13, 2017 Jkt 244001 • Section 211.184—Specifies requirements for component, drug product container, closure, and labeling records. • Section 211.186—Specifies master production and control records requirements. • Section 211.188—Specifies batch production and control records requirement. • Section 211.192—Specifies the information that must be maintained on the investigation of discrepancies found in the review of all drug product production and control records by the quality control staff. • Section 211.194—Explains and describes laboratory records that must be retained. • Section 211.196—Specifies the information that must be included in records on the distribution of the drug. • Section 211.198—Specifies and describes the handling of all complaint files received by the applicant. • Section 211.204—Specifies that records be maintained of returned and salvaged drug products and describes the procedures involved. Written procedures, referred to here as standard operating procedures (SOPs), are required for many part 211 records. Current SOP requirements were initially provided in a final rule published in the Federal Register of September 29, 1978 (43 FR 45014), and are now an integral and familiar part of the drug manufacturing process. The major information collection impact of SOPs results from their creation. Thereafter, SOPs need to be periodically updated. A combined estimate for routine maintenance of SOPs is provided in table 1. The 25 SOP provisions under part 211 in the combined maintenance estimate include: • Section 211.22(d)—Responsibilities and procedures of the quality control unit; • Section 211.56(b)—Sanitation procedures; • Section 211.56(c)—Use of suitable rodenticides, insecticides, fungicides, fumigating agents, and cleaning and sanitizing agents; • Section 211.67(b)—Cleaning and maintenance of equipment; • Section 211.68(a)—Proper performance of automatic, mechanical, and electronic equipment; • Section 211.80(a)—Receipt, identification, storage, handling, sampling, testing, and approval or rejection of components and drug product containers or closures; • Section 211.94(d)—Standards or specifications, methods of testing, and methods of cleaning, sterilizing, and PO 00000 Frm 00022 Fmt 4703 Sfmt 4703 58813 processing to remove pyrogenic properties for drug product containers and closures; • Section 211.100(a)—Production and process control; • Section 211.110(a)—Sampling and testing of in-process materials and drug products; • Section 211.113(a)—Prevention of objectionable microorganisms in drug products not required to be sterile; • Section 211.113(b)—Prevention of microbiological contamination of drug products purporting to be sterile, including validation of any sterilization process; • Section 211.115(a)—System for reprocessing batches that do not conform to standards or specifications to insure that reprocessed batches conform with all established standards, specifications, and characteristics; • Section 211.122(a)—Receipt, identification, storage, handling, sampling, examination and/or testing of labeling and packaging materials; • Section 211.125(f)—Control procedures for the issuance of labeling; • Section 211.130—Packaging and label operations, prevention of mixup and cross contamination, identification and handling of filed drug product containers that are set aside and held in unlabeled condition, and identification of the drug product with a lot or control number that permits determination of the history of the manufacture and control of the batch; • Section 211.142—Warehousing; • Section 211.150—Distribution of drug products; • Section 211.160—Laboratory controls; • Section 211.165(c)—Testing and release for distribution; • Section 211.166(a)—Stability testing; • Section 211.167—Special testing requirements; • Section 211.180(f)—Notification of responsible officials of investigations, recalls, reports of inspectional observations, and any regulatory actions relating to good manufacturing practice; • Section 211.198(a)—Written and oral complaint procedures, including quality control unit review of any complaint involving specifications failures, and serious and unexpected adverse drug experiences; • Section 211.204—Holding, testing, and reprocessing of returned drug products; and • Section 211.208—Drug product salvaging. In addition, the following regulations in parts 610 and 680 (21 CFR parts 610 and 680) reference certain CGMP regulations in part 211: §§ 610.12(g), E:\FR\FM\14DEN1.SGM 14DEN1 58814 Federal Register / Vol. 82, No. 239 / Thursday, December 14, 2017 / Notices Although most CGMP provisions covered in this document were created many years ago, some existing firms expanding into new manufacturing areas and startup firms will need to create SOPs. As provided in table 1, FDA assumes approximately 50 firms 610.13(a)(2), 610.18(d), 680.2(f), and 680.3(f). In table 1, the burden associated with the information collection requirements in these regulations is included in the burden estimates under §§ 211.165, 211.167, 211.188, and 211.194, as appropriate. will have to create up to 25 SOPs for a total of 1,250 records, estimating 20 hours per recordkeeper to create 25 new SOPs for a total of 25,000 hours. FDA estimates the burden of this collection of information as follows: TABLE 1—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1 Number of recordkeepers 21 CFR section/activity SOP Maintenance ................................................................ New Startup SOPs ............................................................... 211.34—Consultants ............................................................ 211.67(c)—Equipment cleaning and maintenance .............. 211.68—Changes in master production and control records or other records ................................................... 211.68(a)—Automatic, mechanical, and electronic equipment .................................................................................. 211.68(b)—Computer or related systems ........................... 211.72—Filters ..................................................................... 211.80(d)—Components and drug product containers or closures ............................................................................ 211.100(b)—Production and process controls .................... 211.105(b)—Equipment identification .................................. 211.122(c)—Labeling and packaging material .................... 211.130(e)—Labeling and packaging facilities .................... 211.132(c)—Tamper-evident packaging .............................. 211.132(d)—Tamper-evident packaging ............................. 211.137—Expiration dating .................................................. 211.160(a)—Laboratory controls ......................................... 211.165(e)—Test methodology ........................................... 211.166—Stability testing .................................................... 211.173—Laboratory animals .............................................. 211.180(e)—Production, control, and distribution records .. 211.180(f)—Procedures for notification of regulatory actions .................................................................................. 211.182—Equipment cleaning and use log ......................... 211.184—Component, drug product container, closure, and labeling records ......................................................... 211.186—Master production and control records ............... 211.188—Batch production and control records ................. 211.192—Discrepancies in drug product production and control records .................................................................. 211.194—Laboratory records .............................................. 211.196—Distribution records ............................................. 211.198—Compliant files ..................................................... 211.204—Returned drug products ...................................... Total .............................................................................. sradovich on DSK3GMQ082PROD with NOTICES 1 Burden Number of records per recordkeeper Total annual records Average burden per recordkeeping (in hours) 1 Total hours 3,270 50 3,270 3,270 ........................ 25 0.25 50 3,270 1,250 818 163,500 25 20 5 0.25 81,750 25,000 4090 40,875 3,270 2 6,540 1 6,540 3,270 3,270 416 10 5 0.25 32,700 16,350 104 0.5 0.25 1 16,350 4,088 104 3,270 3,270 3,270 3,270 3,270 1,613 1,613 3,270 3,270 3,270 3,270 33 3,270 0.25 3 0.25 50 50 20 0.2 5 2 1 2 1 0.2 818 9,810 818 163,500 163,500 32,260 323 16,350 6,540 3,270 6,540 33 654 0.1 2 0.25 0.25 0.25 0.5 0.5 0.5 1 1 0.5 0.25 0.25 82 19,620 205 40,875 40,875 16,130 162 8,175 6,540 3,270 3,270 8 164 3,270 3,270 0.2 2 654 6,540 1 0.25 654 1,635 3,270 3,270 3,270 3 10 25 9,810 32,700 81,750 0.5 2 2 4,905 65,400 163,500 3,270 3,270 3,270 3,270 3,270 2 25 25 5 10 6,540 81,750 81,750 16,350 32,700 1 0.5 0.25 1 0.5 6,540 40,875 20,438 16,350 16,350 ........................ ........................ ........................ ........................ 651,139 estimates of less than 1 hour are expressed as a fraction of an hour in the format ‘‘[number of minutes per response]/60’’. The recordkeeping requirement estimates provided in table 2 are specific to medical gases. In particular, on June 29, 2017, FDA published a Notice of Availability (NOA) in the Federal Register regarding revised draft guidance for industry entitled ‘‘Current Good Manufacturing Practice for Medical Gases’’ (82 FR 29565). This guidance is intended to help medical gas manufacturers comply with applicable CGMP regulations found in VerDate Sep<11>2014 21:28 Dec 13, 2017 Jkt 244001 parts 210 and 211. In the NOA for the revised draft guidance, FDA noted the guidance includes information collection provisions subject to review by the OMB under the PRA and, in accordance with the PRA, before publication of the final guidance, FDA intends to solicit public comment and obtain OMB approval for any recommended new information collections or material modifications to previously approved collections of PO 00000 Frm 00023 Fmt 4703 Sfmt 4703 information found in FDA regulations. This notice is intended to solicit such public comment. The regulations addressed in table 2 are the same as those listed in table 1, but the estimated information collection burden differs and is specific to medical gas manufacturing. FDA estimates the burden of this collection of information as follows: E:\FR\FM\14DEN1.SGM 14DEN1 58815 Federal Register / Vol. 82, No. 239 / Thursday, December 14, 2017 / Notices TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN (MEDICAL GASES) 1 Number of recordkeepers 21 CFR section/activity SOP Maintenance ................................................................ New startup SOPs ............................................................... 211.34—Consultants ............................................................ 211.67(c)—Equipment cleaning and maintenance .............. 211.68—Changes in master production and control records or other records ................................................... 211.68(a)—Automatic, mechanical, and electronic equipment .................................................................................. 211.68(b)—Computer or related systems ........................... 211.72—Filters ..................................................................... 211.80(d)—Components and drug product containers or closures ............................................................................ 211.100(b)—Production and process controls .................... 211.105(b)—Equipment identification .................................. 211.122(c)—Labeling and packaging material .................... 211.130(e)—Labeling and packaging facilities .................... 211.132(c)—Tamper-evident packaging .............................. 211.132(d)—Tamper-evident packaging ............................. 211.137—Expiration dating .................................................. 211.160(a)—Laboratory controls ......................................... 211.165(e)—Test methodology ........................................... 211.166—Stability testing .................................................... 211.173—Laboratory animals .............................................. 211.180(e)—Production, control, and distribution records .. 211.180(f)—Procedures for notification of regulatory actions .................................................................................. 211.182—Equipment cleaning and use log ......................... 211.184—Component, drug product container, closure, and labeling records ......................................................... 211.186—Master production and control records ............... 211.188—Batch production and control records ................. 211.192—Discrepancies in drug product production and control records .................................................................. 211.194—Laboratory records .............................................. 211.196—Distribution records ............................................. 211.198—Complaint files ..................................................... 211.204—Returned drug products ...................................... Total .............................................................................. 1 Burden BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Total hours 0.65 25 0.25 32.5 1,485 2,500 571 74,230 25 20 0.5 0.25 37,125 50,000 286 18,558 2,284 2 4,568 1 4,568 2,284 2,284 2,284 10 5 0.25 22,840 11,420 571 0.5 0.25 1 11,420 2,855 571 2,284 2,284 2,284 2,284 2,284 2,284 2,284 2,284 2,284 2,284 2,284 2,284 2,284 0.25 3 0.25 50 50 20 0.2 3.25 2 1 1.3 1 0.2 571 6,382 571 114,200 114,200 45,680 457 7,423 4,568 2,284 2,969 2,284 457 0.1 2 0.25 0.25 0.25 0.5 0.5 0.33 1 1 0.33 0.25 0.25 57 13,704 143 28,550 28,550 22,840 229 2,450 4,568 2,284 980 571 114 2,284 2,284 0.2 1.3 457 2,969 1 0.16 457 475 2,284 2,284 2,284 1.95 10 16.25 4,454 22,840 37,115 0.33 2 1.3 1,470 45,680 48,250 2,284 2,284 2,284 2,284 2,284 2 25 25 5 10 4,568 57,100 57,100 11,420 22,840 1 0.5 0.25 1 0.5 4,568 28,550 14,275 11,420 11,420 ........................ ........................ ........................ ........................ 396,988 FOR FURTHER INFORMATION CONTACT: [Docket No. FDA–2015–D–4562] sradovich on DSK3GMQ082PROD with NOTICES Average burden per recordkeeping (in hours) 1 2,284 100 2,284 2,284 Investigational New Drug Safety Reporting; Public Workshop’’ that appeared in the Federal Register of November 27, 2017. The document announced a public workshop to engage external stakeholders in discussions related to finalizing the draft guidance entitled ‘‘Safety Assessment for IND Safety Reporting.’’ The date of the meeting has changed. [FR Doc. 2017–26932 Filed 12–13–17; 8:45 am] Public Workshop on Safety Assessment for Investigational New Drug Safety Reporting; Correction Food and Drug Administration, HHS. ACTION: Total annual records estimates of less than 1 hour are expressed as a fraction of an hour in the format ‘‘[number of minutes per response]/60’’. Dated: December 8, 2017. Leslie Kux, Associate Commissioner for Policy. AGENCY: Number of records per recordkeeper Notice; correction. The Food and Drug Administration is correcting a notice entitled ‘‘Safety Assessment for SUMMARY: VerDate Sep<11>2014 21:28 Dec 13, 2017 Jkt 244001 held on January 11, 2018, from 9 a.m. to 4 p.m., Eastern Time.’’ is corrected to read ‘‘The public workshop will be held on March 8, 2018, from 9 a.m. to 4 p.m., Eastern Time.’’ Dated: December 8, 2017. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2017–26938 Filed 12–13–17; 8:45 am] BILLING CODE 4164–01–P Lauren Wedlake, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6362, Silver Spring, MD 20993, 301–796– 2728, Lauren.Wedlake@fda.hhs.gov. In the Federal Register of Monday, November 27, 2017, in FR Doc. 2017– 25454, the following correction is made: 1. On page 56036, in the first column, in the first sentence of the DATES section, ‘‘The public workshop will be PO 00000 Frm 00024 Fmt 4703 Sfmt 9990 E:\FR\FM\14DEN1.SGM 14DEN1

Agencies

[Federal Register Volume 82, Number 239 (Thursday, December 14, 2017)]
[Notices]
[Pages 58811-58815]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-26932]



[[Page 58811]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0362]


Agency Information Collection Activities; Proposed Collection; 
Comment Request; Current Good Manufacturing Practice Regulations for 
Finished Pharmaceuticals

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
an opportunity for public comment on the proposed collection of certain 
information by the Agency. Under the Paperwork Reduction Act of 1995 
(PRA), Federal Agencies are required to publish notice in the Federal 
Register concerning each proposed collection of information, including 
each proposed extension of an existing collection of information, and 
to allow 60 days for public comment in response to the notice. This 
notice solicits comments on the information collection for the Current 
Good Manufacturing Practice Regulations for Finished Pharmaceuticals.

DATES: Submit either electronic or written comments on the collection 
of information by February 12, 2018.

ADDRESSES: You may submit comments as follows. Please note that late, 
untimely filed comments will not be considered. Electronic comments 
must be submitted on or before February 12, 2018. The https://www.regulations.gov electronic filing system will accept comments until 
midnight Eastern Time at the end of February 12, 2018. Comments 
received by mail/hand delivery/courier (for written/paper submissions) 
will be considered timely if they are postmarked or the delivery 
service acceptance receipt is on or before that date.

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper 
submissions): Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets 
Management Staff, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2011-N-0362 for ``Current Good Manufacturing Practice Regulations 
for Finished Pharmaceuticals.'' Received comments, those filed in a 
timely manner (see ADDRESSES), will be placed in the docket and, except 
for those submitted as ``Confidential Submissions,'' publicly viewable 
at https://www.regulations.gov or at the Dockets Management Staff 
office between 9 a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on https://www.regulations.gov. 
Submit both copies to the Dockets Management Staff. If you do not wish 
your name and contact information to be made publicly available, you 
can provide this information on the cover sheet and not in the body of 
your comments and you must identify this information as 
``confidential.'' Any information marked as ``confidential'' will not 
be disclosed except in accordance with 21 CFR 10.20 and other 
applicable disclosure law. For more information about FDA's posting of 
comments to public dockets, see 80 FR 56469, September 18, 2015, or 
access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Domini Bean, Office of Operations, 
Food and Drug Administration, Three White Flint North, 10-12M, 11601 
Landsdown St., North Bethesda, MD 20852, 301-796-5733, 
[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, including 
each proposed extension of an existing 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)

[[Page 58812]]

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.

Current Good Manufacturing Practice Regulations for Finished 
Pharmaceuticals (21 CFR Parts 210 and 211)

OMB Control Number 0910-0139--Extension

    This information collection supports FDA regulations. Specifically, 
under section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act 
(the FD&C Act) (21 U.S.C. 351(a)(2)(B)), a drug is adulterated if the 
methods used in or the facilities or controls used for its manufacture, 
processing, packing, or holding do not conform to or are not operated 
or administered in conformity with Current Good Manufacturing Practice 
(CGMP). The CGMP regulations help ensure drug products meet the 
statutory requirements for safety and have their purported or 
represented identity, strength, quality, and purity characteristics. 
The information collection requirements in the CGMP regulations provide 
FDA with the necessary information to perform its duty to protect 
public health and safety. CGMP requirements establish accountability 
for manufacturing and processing drug products, provide for meaningful 
FDA inspections, and enable manufacturers to improve the quality of 
drug products over time. The CGMP recordkeeping requirements also serve 
preventive and remedial purposes and provide crucial information if it 
is necessary to recall a drug product.
    The general requirements for recordkeeping under part 211 (21 CFR 
part 211) are set forth in Sec.  211.180. Any production, control, or 
distribution record associated with a batch and required to be 
maintained in compliance with part 211 must be retained for at least 1 
year after the expiration date of the batch and, for certain over-the-
counter (OTC) drugs, 3 years after distribution of the batch (Sec.  
211.180(a)). Records for all components, drug product containers, 
closures, and labeling are required to be maintained for at least 1 
year after the expiration date and 3 years for certain OTC products 
(Sec.  211.180(b)).
    All part 211 records must be readily available for authorized 
inspections during the retention period (Sec.  211.180(c)), and such 
records may be retained either as original records or as true copies 
(Sec.  211.180(d)). Additionally, Sec.  11.2(a) (21 CFR 11.2(a)) 
provides that ``for records required to be maintained but not submitted 
to the Agency, persons may use electronic records in lieu of paper 
records or electronic signatures in lieu of traditional signatures, in 
whole or in part, provided that the requirements of this part are 
met.'' To the extent this electronic option is used, the burden of 
maintaining paper records should be substantially reduced, as should 
any review of such records.
    To facilitate improvements and corrective actions, records must be 
maintained so data can be used to evaluate the quality standards of 
each drug product on at least an annual basis and determine whether to 
change any drug product specifications or manufacturing or control 
procedures (Sec.  211.180(e)). Written procedures for these evaluations 
are to be established and include provisions for a review of a 
representative number of batches and, where applicable, records 
associated with the batch; provisions for a review of complaints, 
recalls, returned or salvaged drug products; and investigations 
conducted under Sec.  211.192 for each drug product.
    The specific information collection provisions are as follows:
     Section 211.34--Consultants advising on the manufacture, 
processing, packing, or holding of drug products must have sufficient 
education, training, and experience to advise on the subject for which 
they are retained. Records must be maintained stating the name, 
address, and qualifications of any consultants and the type of service 
they provide.
     Section 211.67(c)--Records must be kept of maintenance, 
cleaning, sanitizing, and inspection as specified in Sec. Sec.  211.180 
and 211.182.
     Section 211.68--Appropriate controls must be exercised 
over computer or related systems to assure that changes in master 
production and control records or other records are instituted only by 
authorized personnel.
     Section 211.68(a)--Records must be maintained of 
calibration checks, inspections, and computer or related system 
programs for automatic, mechanical, and electronic equipment.
     Section 211.68(b)--All appropriate controls must be 
exercised over all computers or related systems and control data 
systems to assure that changes in master production and control records 
or other records are instituted only by authorized persons.
     Section 211.72--Filters for liquid filtration used in the 
manufacture, processing, or packing of injectable drug products 
intended for human use must not release fibers into such products.
     Section 211.80(d)--Each container or grouping of 
containers for components or drug product containers or closures must 
be identified with a distinctive code for each lot in each shipment 
received. This code must be used in recording the disposition of each 
lot. Each lot must be appropriately identified as to its status.
     Section 211.100(b)--Written production and process control 
procedures must be followed in the execution of the various production 
and process control functions and must be documented at the time of 
performance. Any deviation from the written procedures must be recorded 
and justified.
     Section 211.105(b)--Major equipment must be identified by 
a distinctive identification number or code that must be recorded in 
the batch production record to show the specific equipment used in the 
manufacture of each batch of a drug product. In cases where only one of 
a particular type of equipment exists in a manufacturing facility, the 
name of the equipment may be used in lieu of a distinctive 
identification number or code.
     Section 211.122(c)--Records must be maintained for each 
shipment received of each different labeling and packaging material 
indicating receipt, examination, or testing.
     Section 211.130(e)--Inspection of packaging and labeling 
facilities must be made immediately before use to assure that all drug 
products have been removed from previous operations. Inspection must 
also be made to assure that packaging and labeling materials not 
suitable for subsequent operations have been removed. Results of 
inspection must be documented in the batch production records.
     Section 211.132(c)--Certain retail packages of OTC drug 
products must bear a statement that is prominently placed so consumers 
are alerted to the specific tamper-evident feature of the package. The 
labeling statement is required to be so placed that it will be 
unaffected if the tamper-resistant feature of the package is breached 
or missing. If the tamper-evident feature chosen is one that uses an 
identifying characteristic, that characteristic is required to be 
referred to in the labeling statement.
     Section 211.132(d)--A request for an exemption from 
packaging and labeling requirements by a manufacturer or packer is 
required to be submitted in the form of a citizen petition under 21 CFR 
10.30.
     Section 211.137--Requirements regarding product expiration 
dating and compliance with 21 CFR 201.17.

[[Page 58813]]

     Section 211.160(a)--The establishment of any 
specifications, standards, sampling plans, test procedures, or other 
laboratory control mechanisms, including any change in such 
specifications, standards, sampling plans, test procedures, or other 
laboratory control mechanisms, must be drafted by the appropriate 
organizational unit and reviewed and approved by the quality control 
unit. These requirements must be followed and documented at the time of 
performance. Any deviation from the written specifications, standards, 
sampling plans, test procedures, or other laboratory control mechanisms 
must be recorded and justified.
     Section 211.165(e)--The accuracy, sensitivity, 
specificity, and reproducibility of test methods employed by a firm 
must be established and documented. Such validation and documentation 
may be accomplished in accordance with Sec.  211.194(a)(2).
     Section 211.166--Stability testing program for drug 
products.
     Section 211.173--Animals used in testing components, in-
process materials, or drug products for compliance with established 
specifications must be maintained and controlled in a manner that 
assures their suitability for their intended use. They must be 
identified, and adequate records must be maintained showing the history 
of their use.
     Section 211.180(e)--Written records required by part 211 
must be maintained so that data can be used for evaluating, at least 
annually, the quality standards of each drug product to determine the 
need for changes in drug product specifications or manufacturing or 
control procedures. Written procedures must be established and followed 
for such evaluations and must include provisions for a representative 
number of batches, whether approved or unapproved or rejected, and a 
review of complaints, recalls, returned or salvaged drug products, and 
investigations conducted under Sec.  211.192 for each drug product.
     Section 211.180(f)--Procedures must be established to 
assure that the responsible officials of the firm, if they are not 
personally involved in or immediately aware of such actions, are 
notified in writing of any investigations, conducted under Sec.  
211.198, Sec.  211.204, or Sec.  211.208, any recalls, reports of 
inspectional observations issued, or any regulatory actions relating to 
good manufacturing practices brought by FDA.
     Section 211.182--Specifies requirements for equipment 
cleaning records and the use log.
     Section 211.184--Specifies requirements for component, 
drug product container, closure, and labeling records.
     Section 211.186--Specifies master production and control 
records requirements.
     Section 211.188--Specifies batch production and control 
records requirement.
     Section 211.192--Specifies the information that must be 
maintained on the investigation of discrepancies found in the review of 
all drug product production and control records by the quality control 
staff.
     Section 211.194--Explains and describes laboratory records 
that must be retained.
     Section 211.196--Specifies the information that must be 
included in records on the distribution of the drug.
     Section 211.198--Specifies and describes the handling of 
all complaint files received by the applicant.
     Section 211.204--Specifies that records be maintained of 
returned and salvaged drug products and describes the procedures 
involved.
    Written procedures, referred to here as standard operating 
procedures (SOPs), are required for many part 211 records. Current SOP 
requirements were initially provided in a final rule published in the 
Federal Register of September 29, 1978 (43 FR 45014), and are now an 
integral and familiar part of the drug manufacturing process. The major 
information collection impact of SOPs results from their creation. 
Thereafter, SOPs need to be periodically updated. A combined estimate 
for routine maintenance of SOPs is provided in table 1. The 25 SOP 
provisions under part 211 in the combined maintenance estimate include:
     Section 211.22(d)--Responsibilities and procedures of the 
quality control unit;
     Section 211.56(b)--Sanitation procedures;
     Section 211.56(c)--Use of suitable rodenticides, 
insecticides, fungicides, fumigating agents, and cleaning and 
sanitizing agents;
     Section 211.67(b)--Cleaning and maintenance of equipment;
     Section 211.68(a)--Proper performance of automatic, 
mechanical, and electronic equipment;
     Section 211.80(a)--Receipt, identification, storage, 
handling, sampling, testing, and approval or rejection of components 
and drug product containers or closures;
     Section 211.94(d)--Standards or specifications, methods of 
testing, and methods of cleaning, sterilizing, and processing to remove 
pyrogenic properties for drug product containers and closures;
     Section 211.100(a)--Production and process control;
     Section 211.110(a)--Sampling and testing of in-process 
materials and drug products;
     Section 211.113(a)--Prevention of objectionable 
microorganisms in drug products not required to be sterile;
     Section 211.113(b)--Prevention of microbiological 
contamination of drug products purporting to be sterile, including 
validation of any sterilization process;
     Section 211.115(a)--System for reprocessing batches that 
do not conform to standards or specifications to insure that 
reprocessed batches conform with all established standards, 
specifications, and characteristics;
     Section 211.122(a)--Receipt, identification, storage, 
handling, sampling, examination and/or testing of labeling and 
packaging materials;
     Section 211.125(f)--Control procedures for the issuance of 
labeling;
     Section 211.130--Packaging and label operations, 
prevention of mixup and cross contamination, identification and 
handling of filed drug product containers that are set aside and held 
in unlabeled condition, and identification of the drug product with a 
lot or control number that permits determination of the history of the 
manufacture and control of the batch;
     Section 211.142--Warehousing;
     Section 211.150--Distribution of drug products;
     Section 211.160--Laboratory controls;
     Section 211.165(c)--Testing and release for distribution;
     Section 211.166(a)--Stability testing;
     Section 211.167--Special testing requirements;
     Section 211.180(f)--Notification of responsible officials 
of investigations, recalls, reports of inspectional observations, and 
any regulatory actions relating to good manufacturing practice;
     Section 211.198(a)--Written and oral complaint procedures, 
including quality control unit review of any complaint involving 
specifications failures, and serious and unexpected adverse drug 
experiences;
     Section 211.204--Holding, testing, and reprocessing of 
returned drug products; and
     Section 211.208--Drug product salvaging.
    In addition, the following regulations in parts 610 and 680 (21 CFR 
parts 610 and 680) reference certain CGMP regulations in part 211: 
Sec. Sec.  610.12(g),

[[Page 58814]]

610.13(a)(2), 610.18(d), 680.2(f), and 680.3(f). In table 1, the burden 
associated with the information collection requirements in these 
regulations is included in the burden estimates under Sec. Sec.  
211.165, 211.167, 211.188, and 211.194, as appropriate.
    Although most CGMP provisions covered in this document were created 
many years ago, some existing firms expanding into new manufacturing 
areas and startup firms will need to create SOPs. As provided in table 
1, FDA assumes approximately 50 firms will have to create up to 25 SOPs 
for a total of 1,250 records, estimating 20 hours per recordkeeper to 
create 25 new SOPs for a total of 25,000 hours.
    FDA estimates the burden of this collection of information as 
follows:

                               Table 1--Estimated Annual Recordkeeping Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                                                      Average
                                     Number of       Number of     Total annual     burden per
     21 CFR section/activity       recordkeepers    records per       records      recordkeeping    Total hours
                                                   recordkeeper                   (in hours) \1\
----------------------------------------------------------------------------------------------------------------
SOP Maintenance.................           3,270  ..............           3,270              25          81,750
New Startup SOPs................              50              25           1,250              20          25,000
211.34--Consultants.............           3,270            0.25             818               5            4090
211.67(c)--Equipment cleaning              3,270              50         163,500            0.25          40,875
 and maintenance................
211.68--Changes in master                  3,270               2           6,540               1           6,540
 production and control records
 or other records...............
211.68(a)--Automatic,                      3,270              10          32,700             0.5          16,350
 mechanical, and electronic
 equipment......................
211.68(b)--Computer or related             3,270               5          16,350            0.25           4,088
 systems........................
211.72--Filters.................             416            0.25             104               1             104
211.80(d)--Components and drug             3,270            0.25             818             0.1              82
 product containers or closures.
211.100(b)--Production and                 3,270               3           9,810               2          19,620
 process controls...............
211.105(b)--Equipment                      3,270            0.25             818            0.25             205
 identification.................
211.122(c)--Labeling and                   3,270              50         163,500            0.25          40,875
 packaging material.............
211.130(e)--Labeling and                   3,270              50         163,500            0.25          40,875
 packaging facilities...........
211.132(c)--Tamper-evident                 1,613              20          32,260             0.5          16,130
 packaging......................
211.132(d)--Tamper-evident                 1,613             0.2             323             0.5             162
 packaging......................
211.137--Expiration dating......           3,270               5          16,350             0.5           8,175
211.160(a)--Laboratory controls.           3,270               2           6,540               1           6,540
211.165(e)--Test methodology....           3,270               1           3,270               1           3,270
211.166--Stability testing......           3,270               2           6,540             0.5           3,270
211.173--Laboratory animals.....              33               1              33            0.25               8
211.180(e)--Production, control,           3,270             0.2             654            0.25             164
 and distribution records.......
211.180(f)--Procedures for                 3,270             0.2             654               1             654
 notification of regulatory
 actions........................
211.182--Equipment cleaning and            3,270               2           6,540            0.25           1,635
 use log........................
211.184--Component, drug product           3,270               3           9,810             0.5           4,905
 container, closure, and
 labeling records...............
211.186--Master production and             3,270              10          32,700               2          65,400
 control records................
211.188--Batch production and              3,270              25          81,750               2         163,500
 control records................
211.192--Discrepancies in drug             3,270               2           6,540               1           6,540
 product production and control
 records........................
211.194--Laboratory records.....           3,270              25          81,750             0.5          40,875
211.196--Distribution records...           3,270              25          81,750            0.25          20,438
211.198--Compliant files........           3,270               5          16,350               1          16,350
211.204--Returned drug products.           3,270              10          32,700             0.5          16,350
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............         651,139
----------------------------------------------------------------------------------------------------------------
\1\ Burden estimates of less than 1 hour are expressed as a fraction of an hour in the format ``[number of
  minutes per response]/60''.

    The recordkeeping requirement estimates provided in table 2 are 
specific to medical gases. In particular, on June 29, 2017, FDA 
published a Notice of Availability (NOA) in the Federal Register 
regarding revised draft guidance for industry entitled ``Current Good 
Manufacturing Practice for Medical Gases'' (82 FR 29565). This guidance 
is intended to help medical gas manufacturers comply with applicable 
CGMP regulations found in parts 210 and 211. In the NOA for the revised 
draft guidance, FDA noted the guidance includes information collection 
provisions subject to review by the OMB under the PRA and, in 
accordance with the PRA, before publication of the final guidance, FDA 
intends to solicit public comment and obtain OMB approval for any 
recommended new information collections or material modifications to 
previously approved collections of information found in FDA 
regulations. This notice is intended to solicit such public comment.
    The regulations addressed in table 2 are the same as those listed 
in table 1, but the estimated information collection burden differs and 
is specific to medical gas manufacturing. FDA estimates the burden of 
this collection of information as follows:

[[Page 58815]]



                       Table 2--Estimated Annual Recordkeeping Burden (Medical Gases) \1\
----------------------------------------------------------------------------------------------------------------
                                                                                      Average
                                     Number of       Number of     Total annual     burden per
     21 CFR section/activity       recordkeepers    records per       records      recordkeeping    Total hours
                                                   recordkeeper                   (in hours) \1\
----------------------------------------------------------------------------------------------------------------
SOP Maintenance.................           2,284            0.65           1,485              25          37,125
New startup SOPs................             100              25           2,500              20          50,000
211.34--Consultants.............           2,284            0.25             571             0.5             286
211.67(c)--Equipment cleaning              2,284            32.5          74,230            0.25          18,558
 and maintenance................
211.68--Changes in master                  2,284               2           4,568               1           4,568
 production and control records
 or other records...............
211.68(a)--Automatic,                      2,284              10          22,840             0.5          11,420
 mechanical, and electronic
 equipment......................
211.68(b)--Computer or related             2,284               5          11,420            0.25           2,855
 systems........................
211.72--Filters.................           2,284            0.25             571               1             571
211.80(d)--Components and drug             2,284            0.25             571             0.1              57
 product containers or closures.
211.100(b)--Production and                 2,284               3           6,382               2          13,704
 process controls...............
211.105(b)--Equipment                      2,284            0.25             571            0.25             143
 identification.................
211.122(c)--Labeling and                   2,284              50         114,200            0.25          28,550
 packaging material.............
211.130(e)--Labeling and                   2,284              50         114,200            0.25          28,550
 packaging facilities...........
211.132(c)--Tamper-evident                 2,284              20          45,680             0.5          22,840
 packaging......................
211.132(d)--Tamper-evident                 2,284             0.2             457             0.5             229
 packaging......................
211.137--Expiration dating......           2,284            3.25           7,423            0.33           2,450
211.160(a)--Laboratory controls.           2,284               2           4,568               1           4,568
211.165(e)--Test methodology....           2,284               1           2,284               1           2,284
211.166--Stability testing......           2,284             1.3           2,969            0.33             980
211.173--Laboratory animals.....           2,284               1           2,284            0.25             571
211.180(e)--Production, control,           2,284             0.2             457            0.25             114
 and distribution records.......
211.180(f)--Procedures for                 2,284             0.2             457               1             457
 notification of regulatory
 actions........................
211.182--Equipment cleaning and            2,284             1.3           2,969            0.16             475
 use log........................
211.184--Component, drug product           2,284            1.95           4,454            0.33           1,470
 container, closure, and
 labeling records...............
211.186--Master production and             2,284              10          22,840               2          45,680
 control records................
211.188--Batch production and              2,284           16.25          37,115             1.3          48,250
 control records................
211.192--Discrepancies in drug             2,284               2           4,568               1           4,568
 product production and control
 records........................
211.194--Laboratory records.....           2,284              25          57,100             0.5          28,550
211.196--Distribution records...           2,284              25          57,100            0.25          14,275
211.198--Complaint files........           2,284               5          11,420               1          11,420
211.204--Returned drug products.           2,284              10          22,840             0.5          11,420
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............         396,988
----------------------------------------------------------------------------------------------------------------
\1\ Burden estimates of less than 1 hour are expressed as a fraction of an hour in the format ``[number of
  minutes per response]/60''.


    Dated: December 8, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-26932 Filed 12-13-17; 8:45 am]
 BILLING CODE 4164-01-P