81 FR 87572 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Medical Device: Current Good Manufacturing Practice Quality System Regulations
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 81, Issue 233 (December 5, 2016)
Food and Drug Administration
Federal Register Volume 81, Issue 233 (December 5, 2016)
| Page Range | 87572-87575 | |
| FR Document | 2016-29028 |
[Federal Register Volume 81, Number 233 (Monday, December 5, 2016)] [Notices] [Pages 87572-87575] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-29028] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2016-N-2544] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Medical Device: Current Good Manufacturing Practice Quality System Regulations AGENCY: Food and Drug Administration, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995. DATES: Fax written comments on the collection of information by January 4, 2017. ADDRESSES: To ensure that comments on the information collection are received, OMB recommends that written comments be faxed to the Office of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, FAX: 202-395-7285, or emailed to [email protected]. All comments should be identified with the OMB control number 0910-0073. Also include the FDA 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, Three White Flint North, 10A63, 11601 Landsdown St., North Bethesda, MD 20852, [email protected]. SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance. Medical Device: Current Good Manufacturing Practice Quality System Regulations-- OMB Control Number 0910-0073--Extension Under section 520(f) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 360j(f)), the Secretary of the Department of Health and Human Services has the authority to prescribe regulations requiring that the methods used in, and the facilities and controls used for, the manufacture, preproduction design validation (including a process to assess the performance of a device, but not including an evaluation of the safety and effectiveness of a device), packing, storage, and installation of a device conform to Current Good Manufacturing Practice (CGMP), as described in such regulations, to assure that the device will be safe and effective and otherwise in compliance with the FD&C Act. The CGMP/Quality System (QS) regulation implementing authority provided by this statutory provision is found under part 820 (21 CFR part 820) and sets forth basic CGMP requirements governing the design, manufacture, packing, labeling, storage, installation, and servicing of all finished medical devices intended for human use. The authority for this regulation is covered under sections 501, 502, 510, 513, 514, 515, 518, 519, 520, 522, 701, 704, 801, and 803 of the FD&C Act (21 U.S.C. 351, 352, 360, 360c, 360d, 360e, 360h, 360i, 360j, 360l, 371, 374, 381, and 383). The CGMP/QS regulation includes requirements for purchasing and service controls, clarifies recordkeeping requirements for device failure and complaint investigations, clarifies requirements for verifying/validating production processes and process or product changes, and clarifies requirements for product acceptance activities quality data evaluations and corrections of nonconforming product/ quality problems. Requirements are compatible with specifications in the international standards ``ISO 9001: Quality Systems Model for Quality Assurance in Design/Development, Production, Installation, and Servicing.'' The CGMP/QS information collections will assist FDA inspections of manufacturers for compliance with QS requirements encompassing design, production, installation, and servicing processes. Section 820.20(a) through (e) requires management with executive responsibility to establish, maintain, and/or review the following topics: (1) The quality policy, (2) the organizational structure, (3) the quality plan, and (4) the quality system procedures of the organization. Section 820.22 requires the conduct and documentation of QS audits and re-audits. Section 820.25(b) requires the establishment of procedures to identify training needs and documentation of such training. Section 820.30(a)(1) and (b) through (j) requires, in respective order, the establishment, maintenance, and/or documentation of the following topics: (1) Procedures to control design of class III and class II devices and certain class I devices as listed therein; (2) plans for design and development activities and updates; (3) procedures identifying, documenting, and approving design input requirements; (4) procedures defining design output, including acceptance criteria, and documentation of approved records; (5) procedures for formal review of design results and documentation of results in the design history file (DHF); (6) procedures for verifying device design and documentation of results and approvals in the DHF; (7) procedures for validating device design, including documentation of results in the DHF; (8) procedures for translating device design into production specifications; (9) procedures for documenting, verifying, and validating approved design changes before implementation of changes; and (10) the records and references constituting the DHF for each type of device. Section 820.40 requires manufacturers to establish and maintain procedures controlling approval and distribution of required documents and document [[Page 87573]] changes. Section 820.40(a) and (b) requires the establishment and maintenance of procedures for the review, approval, issuance, and documentation of required records (documents) and changes to those records. Section 820.50(a) and (b) requires the establishment and maintenance of procedures and requirements to ensure service and product quality, records of acceptable suppliers, and purchasing data describing specified requirements for products and services. Sections 820.60 and 820.65 require, respectively, the establishment and maintenance of procedures for identifying all products from receipt to distribution and for using control numbers to track surgical implants and life-sustaining or supporting devices and their components. Section 820.70(a) through (e), (g)(1) through (g)(3), (h), and (i) requires the establishment, maintenance, and/or documentation of the following topics: (1) Process control procedures; (2) procedures for verifying or validating changes to specification, method, process, or procedure; (3) procedures to control environmental conditions and inspection result records; (4) requirements for personnel hygiene; (5) procedures for preventing contamination of equipment and products; (6) equipment adjustment, cleaning, and maintenance schedules; (7) equipment inspection records; (8) equipment tolerance postings, procedures for utilizing manufacturing materials expected to have an adverse effect on product quality; and (9) validation protocols and validation records for computer software and software changes. Sections 820.72(a), (b)(1), and (b)(2); and 820.75(a) through (c) require, respectively, the establishment, maintenance, and/or documentation of the following topics: (1) Equipment calibration and inspection procedures; (2) national, international, or in-house calibration standards; (3) records that identify calibrated equipment and next calibration dates; (4) validation procedures and validation results for processes not verifiable by inspections and tests; (5) procedures for keeping validated processes within specified limits; (6) records for monitoring and controlling validated processes; and (7) records of the results of revalidation where necessitated by process changes or deviations. Sections 820.80(a) through (e) and 820.86, respectively, require the establishment, maintenance, and/or documentation of the following topics: (1) Procedures for incoming acceptance by inspection, test, or other verification; (2) procedures for ensuring that in process products meet specified requirements and the control of product until inspection and tests are completed; (3) procedures for, and records that show, incoming acceptance or rejection is conducted by inspections, tests or other verifications; (4) procedures for, and records that show, finished devices meet acceptance criteria and are not distributed until device master record (DMR) activities are completed; (5) records in the device history record (DHR) showing acceptance dates, results, and equipment used; and (6) the acceptance/ rejection identification of products from receipt to installation and servicing. Sections 820.90(a), (b)(1), and (b)(2) and 820.100 require, respectively, the establishment, maintenance and/or documentation of the following topics: (1) Procedures for identifying, recording, evaluating, and disposing of nonconforming product; (2) procedures for reviewing and recording concessions made for, and disposition of, nonconforming product; (3) procedures for reworking products, evaluating possible adverse rework effect and recording results in the DHR; (4) procedures and requirements for corrective and preventive actions, including analysis, investigation, identification and review of data, records, causes, and results; and (5) records for all corrective and preventive action activities. Section 820.100(a)(1) through (a)(7) states that procedures and requirements shall be established and maintained for corrective/ preventive actions, including the following: (1) Analysis of data from process, work, quality, servicing records, investigation of nonconformance causes; (2) identification of corrections and their effectiveness; (3) recording of changes made; and (4) appropriate distribution and managerial review of corrective and preventive action information. Section 820.120 states that manufacturers shall establish/ maintain procedures to control labeling storage/application; and examination/release for storage and use, and document those procedures. Sections 820.120(b) and (d); 820.130; 820.140; 820.150(a) and (b); 820.160(a) and (b); and 820.170(a) and (b), respectively, require the establishment, maintenance, and/or documentation of the following topics: (1) Procedures for controlling and recording the storage, examination, release, and use of labeling; (2) the filing of labels/ labeling used in the DHR; (3) procedures for controlling product storage areas and receipt/dispatch authorizations; (4) procedures controlling the release of products for distribution; (5) distribution records that identify consignee, product, date, and control numbers; and (6) instructions, inspection and test procedures that are made available, and the recording of results for devices requiring installation. Sections 820.180(b) and (c); 820.181(a) through (e); 820.184(a) through (f); and 820.186 require, respectively, the maintenance of records that are: (1) Retained at prescribed site(s), made readily available and accessible to FDA, and retained for the device's life expectancy or for 2 years; (2) contained or referenced in a DMR consisting of device, process, quality assurance, packaging and labeling, and installation, maintenance, and servicing specifications and procedures; (3) contained in a DHR and demonstrate the manufacture of each unit, lot, or batch of product in conformance with DMR and regulatory requirements include manufacturing and distribution dates, quantities, acceptance documents, labels and labeling, and control numbers; and (4) contained in a quality system record, consisting of references, documents, procedures, and activities not specific to particular devices. Sections 820.198(a) through (c); and 820.200(a) through (d), respectively, require the establishment, maintenance, and/or documentation of the following topics: (1) Complaint files and procedures for receiving, reviewing, and evaluating complaints; (2) complaint investigation records identifying the device, complainant, and relationship of the device to the incident; (3) complaint records that are reasonably accessible to the manufacturing site or at prescribed sites; (4) procedures for performing and verifying that device servicing requirements are met and that service reports involving complaints are processed as complaints; and (5) service reports that record the device, service activity, and test and inspection data. Section 820.250 requires the establishment and maintenance of procedures to identify valid statistical techniques necessary to verify process and product acceptability; and sampling plans, when used, which are written and based on valid statistical rationale; and procedures for ensuring adequate sampling methods. The CGMP/QS regulation added design and purchasing controls, modified previous critical device requirements, revised previous validation and other requirements, and harmonized device CGMP requirements with QS specifications in the international standard ``ISO 9001: Quality Systems Model for Quality [[Page 87574]] Assurance in Design/Development, Production, Installation, and Servicing.'' The rule does not apply to manufacturers of components or parts of finished devices, or to manufacturers of human blood and blood components subject to 21 CFR part 606. With respect to devices classified in class I, design control requirements apply only to class I devices listed in Sec. 820.30(a)(2) of the regulation. The rule imposes burden upon: (1) Finished device manufacturer firms, which are subject to all recordkeeping requirements; (2) finished device contract manufacturers, specification developers; and (3) re-packer, re- labelers, and contract sterilizer firms, which are subject only to requirements applicable to their activities. In addition, remanufacturers of hospital single-use devices are now considered to have the same requirements as manufacturers in regard to the regulation. The establishment, maintenance, and/or documentation of procedures, records, and data required by the regulation assists FDA in determining whether firms are in compliance with CGMP requirements, which are intended to ensure that devices meet their design, production, labeling, installation, and servicing specifications and, thus are safe, effective, and suitable for their intended purpose. In particular, compliance with CGMP design control requirements should decrease the number of design-related device failures that have resulted in deaths and serious injuries. The CGMP/QS regulation applies to approximately 24,738 respondents. A query of the Agency's registration and listing database shows that approximately 13,294 domestic and 11,444 foreign establishments are respondents to this information collection.\1\ Respondents to this collection have no reporting activities, but must make required records available for review or copying during FDA inspection. Except for manufacturers, not every type of firm is subject to every CGMP/QS requirement. For example, all are subject to Quality Policy (Sec. 820.20(a)), Document Control (Sec. 820.40), and other requirements, whereas only manufacturers and specification developers are subject to subpart C, Design Controls. The Paperwork Reduction Act burden placed on the 24,738 establishments is an average burden. --------------------------------------------------------------------------- \1\ Based on fiscal year 2015 data. --------------------------------------------------------------------------- In the Federal Register of September 8, 2016 (81 FR 62144), FDA published a 60-day notice requesting public comment on the proposed collection of information. No comments were received. FDA estimates the burden of this collection of information as follows: Table 1--Estimated Annual Recordkeeping Burden \1\ ---------------------------------------------------------------------------------------------------------------- Number of Average burden Activity/21 CFR section Number of records per Total annual per Total recordkeepers recordkeeper records recordkeeping hours ---------------------------------------------------------------------------------------------------------------- Quality policy--820.20(a)........... 24,738 1 24,738 7 173,166 Organization--820.20(b)............. 24,738 1 24,738 4 98,952 Management review--820.20(c)........ 24,738 1 24,738 6 148,428 Quality planning--820.20(d)......... 24,738 1 24,738 10 247,380 Quality system procedures--820.20(e) 24,738 1 24,738 10 247,380 Quality audit--820.22............... 24,738 1 24,738 33 816,354 Training--820.25(b)................. 24,738 1 24,738 13 321,594 Design procedures--820.30(a)(1)..... 24,738 1 24,738 2 49,476 Design and development planning-- 24,738 1 24,738 6 148,428 820.30(b).......................... Design input--820.30(c)............. 24,738 1 24,738 2 49,476 Design output--820.30(d)............ 24,738 1 24,738 2 49,476 Design review--820.30(e)............ 24,738 1 24,738 23 568,974 Design verification--820.30(f)...... 24,738 1 24,738 37 915,306 Design validation--820.30(g)........ 24,738 1 24,738 37 915,306 Design transfer--820.30(h).......... 24,738 1 24,738 3 74,214 Design changes--820.30(i)........... 24,738 1 24,738 17 420,546 Design history file--820.30(j)...... 24,738 1 24,738 3 74,214 Document controls--820.40........... 24,738 1 24,738 9 222,642 Documentation approval and 24,738 1 24,738 2 49,476 distribution and document changes-- 820.40(a) and (b).................. Purchasing controls--820.50(a)...... 24,738 1 24,738 22 544,236 Purchasing data--820.50(b).......... 24,738 1 24,738 6 148,428 Identification--820.60.............. 24,738 1 24,738 1 24,738 Traceability--820.65................ 24,738 1 24,738 1 24,738 Production and process controls-- 24,738 1 24,738 2 49,476 820.70(a).......................... Production and process changes and 24,738 1 24,738 2 49,476 environmental control--820.70(b) and (c)............................ Personnel--820.70(d)................ 24,738 1 24,738 3 74,214 Contamination control--820.70(e).... 24,738 1 24,738 2 49,476 Equipment maintenance schedule, 24,738 1 24,738 1 24,738 inspection, and adjustment-- 820.70(g)(1)-(g)(3)................ Manufacturing material--820.70(h)... 24,738 1 24,738 2 49,476 Automated processes--820.70(i)...... 24,738 1 24,738 8 197,904 Control of inspection, measuring, 24,738 1 24,738 5 123,690 and test equipment--820.72(a)...... Calibration procedures, standards, 24,738 1 24,738 1 24,738 and records--820.72(b)(1)-(b)(2)... Process validation--820.75(a)....... 24,738 1 24,738 3 74,214 Validated process parameters, 24,738 1 24,738 1 24,738 monitoring, control methods, and data--820.75(b).................... Revalidation--820.75(c)............. 24,738 1 24,738 1 24,738 [[Page 87575]] Acceptance activities--820.80(a)-(e) 24,738 1 24,738 5 123,690 Acceptance status--820.86........... 24,738 1 24,738 1 24,738 Control of nonconforming product-- 24,738 1 24,738 5 123,690 820.90(a).......................... Nonconforming product review/ 24,738 1 24,738 5 123,690 disposition procedures and rework procedures--820.90(b)(1)-(b)(2).... Procedures for corrective/preventive 24,738 1 24,738 12 296,856 actions--820.100(a)(1)-(a)(7)...... Corrective/preventive activities-- 24,738 1 24,738 1 24,738 820.100(b)......................... Labeling procedures--820.120(b)..... 24,738 1 24,738 1 24,738 Labeling documentation--820.120(d).. 24,738 1 24,738 1 24,738 Device packaging--820.130........... 24,738 1 24,738 1 24,738 Handling--820.140................... 24,738 1 24,738 6 148,428 Storage--820.150(a) and (b)......... 24,738 1 24,738 6 148,428 Distribution procedures and records-- 24,738 1 24,738 1 24,738 820.160(a) and (b)................. Installation--820.170............... 24,738 1 24,738 2 49,476 Record retention period--820.180(b) 24,738 1 24,738 2 49,476 and (c)............................ Device master record--820.181....... 24,738 1 24,738 1 24,738 Device history record--820.184...... 24,738 1 24,738 1 24,738 Quality system record--820.186...... 24,738 1 24,738 1 24,738 Complaint files--820.198(a), (c), 24,738 1 24,738 5 123,690 and (g)............................ Servicing procedures and reports-- 24,738 1 24,738 3 74,214 820.200(a) and (d)................. Statistical techniques procedures 24,738 1 24,738 1 24,738 and sampling plans--820.250........ --------------------------------------------------------------------------- Total........................... .............. .............. .............. .............. 8,608,824 ---------------------------------------------------------------------------------------------------------------- \1\ There are no capital costs or operating and maintenance costs associated with this collection of information. Dated: November 28, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016-29028 Filed 12-2-16; 8:45 am] BILLING CODE 4160-01-P
![87572 Federal Register / Vol. 81, No. 233 / Monday, December 5, 2016 / Notices
the specific symbols used in labels or FDA estimates the burden of this
labeling for the IVDs manufactured. collection of information as follows:
TABLE 1—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1
Number of Total Average
Number of Total
Activity disclosures per annual burden per
respondents hours
respondent disclosures disclosure
Glossary ..................................................................... 689 1 689 4 2,756
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: November 30, 2016. collection of information to OMB for Model for Quality Assurance in Design/
Leslie Kux, review and clearance. Development, Production, Installation,
Associate Commissioner for Policy. and Servicing.’’ The CGMP/QS
Medical Device: Current Good
[FR Doc. 2016–29104 Filed 12–2–16; 8:45 am] information collections will assist FDA
Manufacturing Practice Quality System
BILLING CODE 4164–01–P inspections of manufacturers for
Regulations— OMB Control Number
compliance with QS requirements
0910–0073—Extension
encompassing design, production,
DEPARTMENT OF HEALTH AND Under section 520(f) of the Federal installation, and servicing processes.
HUMAN SERVICES Food, Drug, and Cosmetic Act (the Section 820.20(a) through (e) requires
FD&C Act) (21 U.S.C. 360j(f)), the management with executive
Food and Drug Administration Secretary of the Department of Health responsibility to establish, maintain,
[Docket No. FDA–2016–N–2544] and Human Services has the authority and/or review the following topics: (1)
to prescribe regulations requiring that The quality policy, (2) the
Agency Information Collection the methods used in, and the facilities organizational structure, (3) the quality
Activities; Submission for Office of and controls used for, the manufacture, plan, and (4) the quality system
Management and Budget Review; preproduction design validation procedures of the organization. Section
Comment Request; Medical Device: (including a process to assess the 820.22 requires the conduct and
Current Good Manufacturing Practice performance of a device, but not documentation of QS audits and re-
Quality System Regulations including an evaluation of the safety audits. Section 820.25(b) requires the
and effectiveness of a device), packing, establishment of procedures to identify
AGENCY: Food and Drug Administration, storage, and installation of a device training needs and documentation of
HHS. conform to Current Good Manufacturing such training.
ACTION: Notice. Practice (CGMP), as described in such Section 820.30(a)(1) and (b) through
SUMMARY: The Food and Drug regulations, to assure that the device (j) requires, in respective order, the
Administration (FDA) is announcing will be safe and effective and otherwise establishment, maintenance, and/or
that a proposed collection of in compliance with the FD&C Act. documentation of the following topics:
information has been submitted to the The CGMP/Quality System (QS) (1) Procedures to control design of class
Office of Management and Budget regulation implementing authority III and class II devices and certain class
(OMB) for review and clearance under provided by this statutory provision is I devices as listed therein; (2) plans for
the Paperwork Reduction Act of 1995. found under part 820 (21 CFR part 820) design and development activities and
and sets forth basic CGMP requirements updates; (3) procedures identifying,
DATES: Fax written comments on the
governing the design, manufacture, documenting, and approving design
collection of information by January 4,
packing, labeling, storage, installation, input requirements; (4) procedures
2017.
and servicing of all finished medical defining design output, including
ADDRESSES: To ensure that comments on
devices intended for human use. The acceptance criteria, and documentation
the information collection are received, authority for this regulation is covered of approved records; (5) procedures for
OMB recommends that written under sections 501, 502, 510, 513, 514, formal review of design results and
comments be faxed to the Office of 515, 518, 519, 520, 522, 701, 704, 801, documentation of results in the design
Information and Regulatory Affairs, and 803 of the FD&C Act (21 U.S.C. 351, history file (DHF); (6) procedures for
OMB, Attn: FDA Desk Officer, FAX: 352, 360, 360c, 360d, 360e, 360h, 360i, verifying device design and
202–395–7285, or emailed to oira_ 360j, 360l, 371, 374, 381, and 383). The documentation of results and approvals
submission@omb.eop.gov. All CGMP/QS regulation includes in the DHF; (7) procedures for validating
comments should be identified with the requirements for purchasing and service device design, including documentation
OMB control number 0910–0073. Also controls, clarifies recordkeeping of results in the DHF; (8) procedures for
include the FDA docket number found requirements for device failure and translating device design into
in brackets in the heading of this complaint investigations, clarifies production specifications; (9)
document. requirements for verifying/validating procedures for documenting, verifying,
FOR FURTHER INFORMATION CONTACT: FDA production processes and process or and validating approved design changes
PRA Staff, Office of Operations, Food product changes, and clarifies before implementation of changes; and
sradovich on DSK3GMQ082PROD with NOTICES
and Drug Administration, Three White requirements for product acceptance (10) the records and references
Flint North, 10A63, 11601 Landsdown activities quality data evaluations and constituting the DHF for each type of
St., North Bethesda, MD 20852, corrections of nonconforming product/ device.
PRAStaff@fda.hhs.gov. quality problems. Section 820.40 requires manufacturers
SUPPLEMENTARY INFORMATION: In Requirements are compatible with to establish and maintain procedures
compliance with 44 U.S.C. 3507, FDA specifications in the international controlling approval and distribution of
has submitted the following proposed standards ‘‘ISO 9001: Quality Systems required documents and document
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![Federal Register / Vol. 81, No. 233 / Monday, December 5, 2016 / Notices 87575
TABLE 1—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1—Continued
Number of Average
Number of Total annual
Activity/21 CFR section records per burden per Total hours
recordkeepers records
recordkeeper recordkeeping
Acceptance activities—820.80(a)–(e) ........................................ 24,738 1 24,738 5 123,690
Acceptance status—820.86 ....................................................... 24,738 1 24,738 1 24,738
Control of nonconforming product—820.90(a) .......................... 24,738 1 24,738 5 123,690
Nonconforming product review/disposition procedures and re-
work procedures—820.90(b)(1)–(b)(2) ................................... 24,738 1 24,738 5 123,690
Procedures for corrective/preventive actions—820.100(a)(1)–
(a)(7) ....................................................................................... 24,738 1 24,738 12 296,856
Corrective/preventive activities—820.100(b) ............................. 24,738 1 24,738 1 24,738
Labeling procedures—820.120(b) ............................................. 24,738 1 24,738 1 24,738
Labeling documentation—820.120(d) ........................................ 24,738 1 24,738 1 24,738
Device packaging—820.130 ...................................................... 24,738 1 24,738 1 24,738
Handling—820.140 .................................................................... 24,738 1 24,738 6 148,428
Storage—820.150(a) and (b) ..................................................... 24,738 1 24,738 6 148,428
Distribution procedures and records—820.160(a) and (b) ........ 24,738 1 24,738 1 24,738
Installation—820.170 ................................................................. 24,738 1 24,738 2 49,476
Record retention period—820.180(b) and (c) ............................ 24,738 1 24,738 2 49,476
Device master record—820.181 ................................................ 24,738 1 24,738 1 24,738
Device history record—820.184 ................................................ 24,738 1 24,738 1 24,738
Quality system record—820.186 ............................................... 24,738 1 24,738 1 24,738
Complaint files—820.198(a), (c), and (g) .................................. 24,738 1 24,738 5 123,690
Servicing procedures and reports—820.200(a) and (d) ............ 24,738 1 24,738 3 74,214
Statistical techniques procedures and sampling plans—
820.250 ................................................................................... 24,738 1 24,738 1 24,738
Total .................................................................................... ........................ ........................ ........................ ........................ 8,608,824
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: November 28, 2016. ‘‘Providing Information About Pediatric public, submit the comment as a
Leslie Kux, Uses of Medical Devices Under Section written/paper submission and in the
Associate Commissioner for Policy. 515A of the Federal Food, Drug, and manner detailed (see ‘‘Written/Paper
[FR Doc. 2016–29028 Filed 12–2–16; 8:45 am] Cosmetic Act.’’ Submissions’’ and ‘‘Instructions’’).
BILLING CODE 4160–01–P DATES: Submit either electronic or Written/Paper Submissions
written comments on the collection of
information by February 3, 2017. Submit written/paper submissions as
DEPARTMENT OF HEALTH AND ADDRESSES: You may submit comments follows:
HUMAN SERVICES as follows: • Mail/Hand delivery/Courier (for
written/paper submissions): Division of
Food and Drug Administration Electronic Submissions Dockets Management (HFA–305), Food
[Docket No. FDA–2013–D–0117] Submit electronic comments in the and Drug Administration, 5630 Fishers
following way: Lane, Rm. 1061, Rockville, MD 20852.
Agency Information Collection • Federal eRulemaking Portal: • For written/paper comments
Activities; Proposed Collection; https://www.regulations.gov. Follow the submitted to the Division of Dockets
Comment Request; Providing instructions for submitting comments. Management, FDA will post your
Information About Pediatric Uses of Comments submitted electronically, comment, as well as any attachments,
Medical Devices including attachments, to https:// except for information submitted,
www.regulations.gov will be posted to marked and identified, as confidential,
AGENCY: Food and Drug Administration,
the docket unchanged. Because your if submitted as detailed in
HHS.
comment will be made public, you are ‘‘Instructions.’’
ACTION: Notice. Instructions: All submissions received
solely responsible for ensuring that your
SUMMARY: The Food and Drug comment does not include any must include the Docket No. FDA–
Administration (FDA) is announcing an confidential information that you or a 2013–D–0117 for ‘‘Agency Information
opportunity for public comment on the third party may not wish to be posted, Collection Activities; Proposed
proposed collection of certain such as medical information, your or Collection; Comment Request; Providing
information by the Agency. Under the anyone else’s Social Security number, or Information About Pediatric Uses of
Paperwork Reduction Act of 1995 (the confidential business information, such Medical Devices.’’ Received comments
PRA), Federal Agencies are required to as a manufacturing process. Please note will be placed in the docket and, except
for those submitted as ‘‘Confidential
sradovich on DSK3GMQ082PROD with NOTICES
publish notice in the Federal Register that if you include your name, contact
concerning each proposed collection of information, or other information that Submissions,’’ publicly viewable at
information, including each proposed identifies you in the body of your https://www.regulations.gov or at the
extension of an existing collection of comments, that information will be Division of Dockets Management
information, and to allow 60 days for posted on https://www.regulations.gov. between 9 a.m. and 4 p.m., Monday
public comment in response to the • If you want to submit a comment through Friday.
notice. This notice solicits comments on with confidential information that you • Confidential Submissions—To
the information collection regarding do not wish to be made available to the submit a comment with confidential
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Document Created: 2016-12-03 00:26:14
Document Modified: 2016-12-03 00:26:14
| 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 | Fax written comments on the collection of information by January 4, 2017. | |
| Contact | FDA PRA Staff, Office of Operations, Food and Drug Administration, Three White Flint North, 10A63, 11601 Landsdown St., North Bethesda, MD 20852, [email protected] | |
| FR Citation | 81 FR 87572 |
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