Source: https://regulations.justia.com/regulations/fedreg/2019/03/14/2019-04717.html
Timestamp: 2019-05-21 19:31:22
Document Index: 666043304

Matched Legal Cases: ['§ 212', '§ 212', '§ 212', '§ 212', '§ 212', '§ 212', '§ 212', '§ 212', '§ 212', '§ 212']

Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Devices; Inspection by Accredited Persons Program, 9352-9354 [2019-04717] :: Food And Drug Administration :: Department Of Health And Human Services :: Regulation Tracker :: Justia
Justia Regulation Tracker Department Of Health And Human Services Food And Drug Administration Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Devices; Inspection by Accredited Persons Program, 9352-9354 [2019-04717]
Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Devices; Inspection by Accredited Persons Program, 9352-9354 [2019-04717]
Download as PDF 9352 Federal Register / Vol. 84, No. 50 / Thursday, March 14, 2019 / Notices TABLE 4—ESTIMATED ANNUAL RECORDKEEPING BURDEN FOR ACADEMIA AND SMALL FIRMS 1—Continued Number of recordkeepers Activity/21 CFR section Out-of-Specification Investigations (record events and investigations) (§ 212.71(b)). Complaints (Record events and investigations) (§§ 212.100(b) and (c)). QA and Release of Batches ........................................ Distribution Records (§ 212.90(b)) ............................... Total ...................................................................... 1 There Number of records per recordkeeper Average burden per recordkeeper Total annual records Total hours 2 52 2 104 2 ............................. 208 52 2 104 2 ............................. 208 52 52 24 24 1,248 1,248 0.25 (15 minutes) ... 0.25 (15 minutes) ... 312 312 ........................ ........................ ........................ ................................ 4,732 are no capital costs or operating and maintenance costs associated with this collection of information. rounded to the nearest whole number. 2 Number TABLE 5—ESTIMATED ANNUAL RECORDKEEPING BURDEN FOR HIGH RISK COMPONENT MANUFACTURERS 1 Number of recordkeepers Activity/21 CFR section Batch Production (creating manufacturing records and batch related records per year) (§§ 212.20(c) and (e) and 212.50(a) and (b)). Equipment and Facilities Records (calibration and cleaning records systems) (§§ 212.30(b), 212.50(d), and 212.60(f)). Records of Components, Containers, and Closures (incoming acceptance test) (§§ 212.20(c) and 212.40(a) and (b)). Laboratory Testing Records (record QC test results) §§ 212.60(g), 212.61(b) and 212.70(d)(2) and (3). Out-of-Specification Investigations (Record events and investigations) (§ 212.71(b)). QA and Release of Batches ........................................ Distribution Records (§ 212.90(b)) ............................... Total ...................................................................... Number of records per recordkeeper Average burden per recordkeeper Total annual records Total hours 2 9 12 108 0.50 (30 minutes) .. 54 9 16 144 0.50 (30 minutes) .. 72 9 6 54 0.50 (30 minutes) ... 27 9 12 108 0.50 (30 minutes) ... 54 9 1 9 1 ............................. 9 9 9 12 12 108 108 0.25 (15 minutes) ... 0.25 (15 minutes) ... 27 27 ........................ ........................ ........................ ................................ 270 1 There are no capital costs or operating and maintenance costs associated with this collection of information. 2 Number rounded to the nearest whole number. TABLE 6—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1 Activity/21 CFR section Number of sterility failure incidents Number of disclosures per respondent Total annual disclosures Average burden per disclosure Total hours Sterility Test Failure Notices (§ 212.70(e)) .................. 12 23 36 2.5 90 1 There 2 There are no capital costs or operating and maintenance costs associated with this collection of information. are two reports sent to FDA per incident and notification to receiving site. These burden estimates reflect adjustments since last OMB approval. Previously we had based the estimated number of respondents on the number of individual production sites, however we believe using the number of registered organizations better reflects the burden attributable to information collection. This results in an overall decrease to the collection. Dated: March 8, 2019. Lowell J. Schiller, Acting Associate Commissioner for Policy. [FR Doc. 2019–04716 Filed 3–13–19; 8:45 am] 17:22 Mar 13, 2019 Food and Drug Administration [Docket No. FDA–2012–N–0427] Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Devices; Inspection by Accredited Persons Program AGENCY: Food and Drug Administration, HHS. ACTION: Notice. Jkt 247001 PO 00000 Frm 00065 Fmt 4703 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 Inspection by Accredited Persons Program. Submit either electronic or written comments on the collection of information by May 13, 2019. DATES: The Food and Drug Administration (FDA or Agency) is SUMMARY: BILLING CODE 4164–01–P VerDate Sep<11>2014 DEPARTMENT OF HEALTH AND HUMAN SERVICES Sfmt 4703 E:\FR\FM\14MRN1.SGM 14MRN1 Federal Register / Vol. 84, No. 50 / Thursday, March 14, 2019 / Notices 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 May 13, 2019. The https://www.regulations.gov electronic filing system will accept comments until 11:59 p.m. Eastern Time at the end of May 13, 2019. 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. ADDRESSES: 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– 2012–N–0427 for ‘‘Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Devices; Inspection by Accredited VerDate Sep<11>2014 17:22 Mar 13, 2019 Jkt 247001 Persons Program.’’ 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 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/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: Amber Sanford, Office of Operations, Food and Drug Administration, Three White Flint North, 10A–12M, 11601 Landsdown St., North Bethesda, MD 20852, 301–796–8867, 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 PO 00000 Frm 00066 Fmt 4703 Sfmt 4703 9353 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) 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. Inspection by Accredited Persons Program Under the Medical Device User Fee and Modernization Act of 2002 OMB Control Number 0910–0510— Extension The Medical Device User Fee and Modernization Act of 2002 (MDUFMA) (Pub. L. 107–250) was signed into law on October 26, 2002. Section 201 of MDUFMA added a new paragraph (g) to section 704 of the Federal, Food, Drug, and Cosmetic Act (21 U.S.C. 374), directing FDA to accredit third parties (accredited persons) to conduct inspections of eligible manufacturers of class II or class III devices. FDA’s guidance document entitled ‘‘Inspection by Accredited Persons Under The Medical Device User Fee and Modernization Act of 2002 and the FDA Amendments Act of 2007; Accreditation Criteria’’ 1 provides information for 1 https://www.fda.gov/ucm/groups/fdagov-public/ @fdagov-meddev-gen/documents/document/ ucm089721.pdf. E:\FR\FM\14MRN1.SGM 14MRN1 9354 Federal Register / Vol. 84, No. 50 / Thursday, March 14, 2019 / Notices those interested in participating in this voluntary program. FDA estimates the burden of this collection of information as follows: TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1 Section of the FD&C act; activity Number of respondents Number of responses per respondent Total annual responses Average burden per response Total hours 704(g); Request for Accreditation ........................................ 1 1 1 80 80 1 There are no capital costs or operating and maintenance costs associated with this collection of information. Based on a review of the information collection since our last request for OMB approval, we have made no adjustments to our burden estimate. Dated: March 8, 2019. Lowell J. Schiller, Acting Associate Commissioner for Policy. [FR Doc. 2019–04717 Filed 3–13–19; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2004–N–0451] Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 051 AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA or Agency) is announcing a publication containing modifications the Agency is making to the list of standards FDA recognizes for use in premarket reviews (FDA Recognized Consensus Standards). This publication, entitled ‘‘Modifications to the List of Recognized Standards, Recognition List Number: 051’’ (Recognition List Number: 051), will assist manufacturers who elect to declare conformity with consensus standards to meet certain requirements for medical devices. DATES: Submit either electronic or written comments on the notice at any time. These modifications to the list of recognized standards are applicable March 14, 2019. ADDRESSES: You may submit comments on the current list of FDA Recognized Consensus Standards at any time as follows: SUMMARY: Electronic Submissions Submit electronic comments in the following way: VerDate Sep<11>2014 17:22 Mar 13, 2019 Jkt 247001 • 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– 2004–N–0451 for ‘‘Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 051.’’ Received comments 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 between 9 PO 00000 Frm 00067 Fmt 4703 Sfmt 4703 a.m. and 4 p.m., Monday through Friday. FDA will consider any comments received in determining whether to amend the current listing of modifications to the list of recognized standards, Recognition List Number: 051. • 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: http://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. An electronic copy of Recognition List Number: 051 is available on the internet E:\FR\FM\14MRN1.SGM 14MRN1
[Pages 9352-9354]
[FR Doc No: 2019-04717]
Comment Request; Medical Devices; Inspection by Accredited Persons
notice solicits comments on the Inspection by Accredited Persons
of information by May 13, 2019.
must be submitted on or before May 13, 2019. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of May 13, 2019. Comments received
FDA-2012-N-0427 for ``Agency Information Collection Activities;
Proposed Collection; Comment Request; Medical Devices; Inspection by
Accredited Persons Program.'' Received comments, those filed in a
Fee and Modernization Act of 2002
OMB Control Number 0910-0510--Extension
of MDUFMA added a new paragraph (g) to section 704 of the Federal,
Food, Drug, and Cosmetic Act (21 U.S.C. 374), directing FDA to accredit
third parties (accredited persons) to conduct inspections of eligible
manufacturers of class II or class III devices. FDA's guidance document
entitled ``Inspection by Accredited Persons Under The Medical Device
User Fee and Modernization Act of 2002 and the FDA Amendments Act of
2007; Accreditation Criteria'' \1\ provides information for
those interested in participating in this voluntary program.
\1\ https://www.fda.gov/ucm/groups/fdagov-public/@fdagov-meddev-gen/documents/document/ucm089721.pdf.
Section of the FD&C act; activity                      Number of      responses per     Total annual    Average burden    Total hours
704(g); Request for Accreditation..................................               1                1                1               80               80