Biosimilar User Fee Act; Public Meeting; Correction, 66970 [2016-23523]

Download as PDF 66970 Federal Register / Vol. 81, No. 189 / Thursday, September 29, 2016 / Notices TABLE 1—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1—Continued Number of recordkeepers 21 CFR Section Number of records per recordkeeper Average burden per recordkeeping Total annual records Total hours 111.570, Records regarding product complaints .............. 240 600 144,000 0.5 (30 minutes) 72,000 Total ........................................................................... ........................ ........................ ........................ ........................... 929,140 mstockstill on DSK3G9T082PROD with NOTICES 1 There are no capital costs or operating and maintenance costs associated with this collection of information. The average burden per recordkeeping estimates in Table 1 of this document are based on those in the June 25, 2007, final rule, which were based on our institutional experience with other CGMP requirements and on data provided by Research Triangle Institute in the ‘‘Survey of Manufacturing Practices in the Dietary Supplement Industry’’ cited in that rule. The estimates in table 1 of the number of firms affected by each provision of part 111 are based on the percentage of manufacturers, packagers, labelers, holders, distributors, and warehousers that reported in the survey that they have not established written SOPs or do not maintain records that were later required by the June 25, 2007, final rule. Because we do not have survey results for general warehouses, we entered the approximate number of facilities in that category for those provisions covering general facilities. For the dietary supplement industry, the survey estimated that 1,460 firms would be covered by the final rule, including manufacturers, packagers, labelers, holders, distributors, and warehousers. The time estimates include the burden involved in documenting that certain requirements are performed and in recordkeeping. We used an estimated annual batch production of 1,408 batches per year to estimate the burden of requirements that are related to the number of batches produced annually, such as § 111.260, ‘‘What must the batch production record include?’’ The estimate of 1,408 batches per year is near the midpoint of the number of annual batches reported by survey firms. The length of time that CGMP records must be maintained is set forth in § 111.605. Table 1 of this document reflects the estimated burdens for written procedures, record maintenance, periodically reviewing records to determine if they may be discarded, and for any associated documentation for that activity for records that are required under part 111. We have not included a separate estimate of burden for those sections that require maintaining records in accordance with § 111.605, but have included those burdens under VerDate Sep<11>2014 18:51 Sep 28, 2016 Jkt 238001 specific provisions for keeping records. For example, § 111.255(a) requires that the batch production records be prepared every time a batch is manufactured, and § 111.255(d) requires that batch production records be kept in accordance with § 111.605. The estimated burdens for both § 111.255(a) and (d) are included under § 111.260, what the batch record must include. Dated: September 23, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016–23521 Filed 9–28–16; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2015–N–3326] Biosimilar User Fee Act; Public Meeting; Correction AGENCY: Food and Drug Administration, HHS. ACTION: Notice; correction. PO 00000 Frm 00052 Fmt 4703 Sfmt 4703 Dated: September 23, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016–23523 Filed 9–28–16; 8:45 am] The Food and Drug Administration is correcting a notice entitled ‘‘Biosimilar User Fee Act; Public Meeting’’ that appeared in the Federal Register of September 19, 2016 (81 FR 64171). The document announced a public meeting to discuss proposed recommendations for the reauthorization of the Biosimilar User Fee Act (BsUFA) for fiscal years (FYs) 2018 through 2022. The document was published with the incorrect date of the closure of the docket and incorrect transcript information. This document corrects those errors. FOR FURTHER INFORMATION CONTACT: Lisa Granger, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 3330, Silver Spring, MD 20993– 0002, 301–796–9115, lisa.granger@ fda.hhs.gov. SUPPLEMENTARY INFORMATION: In the Federal Register of Monday, September 19, 2016, in FR Doc. 2016–22442, the following corrections are made: 1. On page 64172, in the first column, in the third sentence of the DATES SUMMARY: section, ‘‘October 19, 2016’’ is corrected to read ‘‘October 28, 2016.’’ 2. On page 64175, in the third column, the section ‘‘Transcripts: As soon as a transcript is available, FDA will post it at http://www.fda.gov/ ForIndustry/UserFees/BiosimilarUser FeeActBsUFA/ucm461774.htm.’’ is corrected to read ‘‘Transcripts: Please be advised that as soon as a transcript is available, it will be accessible at http:// www.regulations.gov and http:// www.fda.gov/ForIndustry/UserFees/ BiosimilarUserFeeActBsUFA/ ucm461774.htm. It may be viewed at the Division of Dockets Management, Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD. A transcript will also be available in either hardcopy or on CD–ROM, after submission of a Freedom of Information request. The Freedom of Information office address is available on the Agency’s Web site at http:// www.fda.gov.’’ BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources And Services Administration National Vaccine Injury Compensation Program; List of Petitions Received Health Resources and Services Administration (HRSA), Department of Health and Human Services (HHS). ACTION: Notice. AGENCY: HRSA is publishing this notice of petitions received under the National Vaccine Injury Compensation Program (the Program), as required by Section 2112(b)(2) of the Public Health Service (PHS) Act, as amended. While the Secretary of HHS (the Secretary) is named as the respondent in all proceedings brought by the filing of petitions for compensation under the Program, the United States Court of Federal Claims is charged by statute SUMMARY: E:\FR\FM\29SEN1.SGM 29SEN1

Agencies

[Federal Register Volume 81, Number 189 (Thursday, September 29, 2016)]
[Notices]
[Page 66970]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-23523]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-N-3326]


Biosimilar User Fee Act; Public Meeting; Correction

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; correction.

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SUMMARY: The Food and Drug Administration is correcting a notice 
entitled ``Biosimilar User Fee Act; Public Meeting'' that appeared in 
the Federal Register of September 19, 2016 (81 FR 64171). The document 
announced a public meeting to discuss proposed recommendations for the 
reauthorization of the Biosimilar User Fee Act (BsUFA) for fiscal years 
(FYs) 2018 through 2022. The document was published with the incorrect 
date of the closure of the docket and incorrect transcript information. 
This document corrects those errors.

FOR FURTHER INFORMATION CONTACT: Lisa Granger, Food and Drug 
Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 3330, Silver 
Spring, MD 20993-0002, 301-796-9115, lisa.granger@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: In the Federal Register of Monday, September 
19, 2016, in FR Doc. 2016-22442, the following corrections are made:
    1. On page 64172, in the first column, in the third sentence of the 
DATES section, ``October 19, 2016'' is corrected to read ``October 28, 
2016.''
    2. On page 64175, in the third column, the section ``Transcripts: 
As soon as a transcript is available, FDA will post it at http://www.fda.gov/ForIndustry/UserFees/BiosimilarUserFeeActBsUFA/ucm461774.htm.'' is corrected to read ``Transcripts: Please be advised 
that as soon as a transcript is available, it will be accessible at 
http://www.regulations.gov and http://www.fda.gov/ForIndustry/UserFees/BiosimilarUserFeeActBsUFA/ucm461774.htm. It may be viewed at the 
Division of Dockets Management, Food and Drug Administration, 5630 
Fishers Lane, Rm. 1061, Rockville, MD. A transcript will also be 
available in either hardcopy or on CD-ROM, after submission of a 
Freedom of Information request. The Freedom of Information office 
address is available on the Agency's Web site at http://www.fda.gov.''

    Dated: September 23, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-23523 Filed 9-28-16; 8:45 am]
BILLING CODE 4164-01-P