81 FR 66967 - Agency Information Collection Activities; Proposed Collection; Comment Request; Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 81, Issue 189 (September 29, 2016)
Food and Drug Administration
Federal Register Volume 81, Issue 189 (September 29, 2016)
| Page Range | 66967-66970 | |
| FR Document | 2016-23521 |
[Federal Register Volume 81, Number 189 (Thursday, September 29, 2016)] [Notices] [Pages 66967-66970] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-23521] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-N-1619] Agency Information Collection Activities; Proposed Collection; Comment Request; Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements AGENCY: Food and Drug Administration, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA or we) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, 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 invites comments on the information collection provisions of FDA's regulations regarding current good manufacturing practice (CGMP) for dietary supplements. DATES: Submit either electronic or written comments on the collection of information by November 28, 2016. ADDRESSES: You may submit comments as follows: Electronic Submissions Submit electronic comments in the following way:Federal eRulemaking Portal: http://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to http://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 http://www.regulations.gov. If you want to submit a comment with confidential information that you [[Page 66968]] 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): Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. For written/paper comments submitted to the Division of Dockets Management, 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-2013-N-1619 for ``Agency Information Collection Activities; Proposed Collection; Comment Request; Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements.'' Received comments will be placed in the docket and, except for those submitted as ``Confidential Submissions,'' publicly viewable at http://www.regulations.gov or at the Division of Dockets Management 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 http://www.regulations.gov. Submit both copies to the Division of Dockets Management. 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.fda.gov/regulatoryinformation/dockets/default.htm. Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to http://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 Division of Dockets Management, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. 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: 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) 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 in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements--21 CFR Part 111; OMB Control Number 0910-0606--Extension On October 25, 1994, the Dietary Supplement Health and Education Act (DSHEA) (Pub. L. 103-417) was signed into law. DSHEA, among other things, amended the Federal Food, Drug, and Cosmetic Act (the FD&C Act) by adding section 402(g) of the FD&C Act (21 U.S.C. 342(g)). Section 402(g)(2) of the FD&C Act provides, in part, that the Secretary of Health and Human Services may, by regulation, prescribe good manufacturing practices for dietary supplements. Section 402(g) of the FD&C Act also stipulates that such regulations will be modeled after CGMP regulations for food and may not impose standards for which there are no current, and generally available, analytical methodology. Section 402(g)(1) of the FD&C Act states that a dietary supplement is adulterated if ``it has been prepared, packed, or held under conditions that do not meet current good manufacturing practice regulations.'' Under section 701(a) of the FD&C Act (21 U.S.C. 371), FDA may issue regulations necessary for the efficient enforcement of the FD&C Act. In the Federal Register of June 25, 2007 (72 FR 34752), (the June 25, 2007, final rule), FDA published a final rule that established, in part 111 (21 CFR part 111), the minimum CGMP necessary for activities related to manufacturing, packaging, labeling, or holding dietary supplements to ensure the quality of the dietary supplement. Records are an indispensable component of CGMP. The records required by FDA's regulations in part 111 provide the foundation for the planning, control, and improvement processes that constitute a quality control system. Implementation of these processes in a manufacturing operation serves as the backbone to CGMP. The records show what is to be manufactured; what was, in fact, manufactured; and whether the controls that the manufacturer put in place to ensure the identity, purity, strength, and composition and limits on contaminants and to prevent adulteration were effective. Further, records will show whether and what deviations from control processes occurred, facilitate evaluation and corrective action concerning these deviations (including, where necessary, whether associated batches of product should be recalled from the marketplace), and enable a manufacturer to assure that the corrective action was effective. In [[Page 66969]] addition, by establishing recordkeeping requirements, FDA can ensure that industry follows CGMP during manufacturing, packaging, labeling, or holding operations. The regulations in part 111 establish the minimum manufacturing practices necessary to ensure that dietary supplements are manufactured, packaged, labeled, or held in a manner that will ensure the quality of the dietary supplements during manufacturing, packaging, labeling or holding operations. The recordkeeping requirements of the regulations include establishing written procedures and maintaining records pertaining to: (1) Personnel; (2) sanitation; (3) calibration of instruments and controls; (4) calibration, inspection, or checks of automated, mechanical, or electronic equipment; (5) maintaining, cleaning, and sanitizing equipment and utensils and other contact surfaces; (6) water used that may become a component of the dietary supplement; (7) production and process controls; (8) quality control; (9) components, packaging, labels and product received for packaging and labeling; (10) master manufacturing and batch production; (11) laboratory operations; (12) manufacturing operations; (13) packaging and labeling operations; (14) holding and distributing operations; (15) returned dietary supplements; and (16) product complaints. Description of Respondents: Manufacturers, dietary supplement manufacturers, packagers and repackagers, labelers and re-labelers, holders, distributors, warehousers, exporters, importers, large businesses, and small businesses engaged in the dietary supplement industry. The recordkeeping requirements of the regulations in part 111 are set forth in each subpart. In table 1 of this document, we list the annual burdens associated with recordkeeping, as described in the June 25, 2007, final rule. For some provisions listed in table 1, we did not estimate the number of records per recordkeeper because recordkeeping occasions consist of frequent brief entries of dates, temperatures, monitoring results, or documentation that specific actions were taken. Information might be recorded a few times a day, week, or month. When the records burden involves frequent brief entries, we entered 1 as the default for the number of records per recordkeeper. For example, many of the records listed under Sec. 111.35 in table 1, such as Sec. 111.35(b)(2) (documentation, in individual equipment logs, of the date of the use, maintenance, cleaning, and sanitizing of equipment), involve many short sporadic entries over the course of the year, varying across equipment and plants in the industry. We did not attempt to estimate the actual number of recordkeeping occasions for these provisions, but instead entered an estimate of the average number of hours per year. We entered the default value of 1 as the number of records per recordkeeper for these and similar provisions. For Sec. 111.35, the entry for number of records is 1 as a default representing a large number of brief recordkeeping occasions. In many rows of table 1 of this document, we list a burden under a single provision that covers the written procedures or records described in several provisions. For example, the burden of the batch production records listed in table 1 under Sec. 111.260 includes the burden for records listed under Sec. 111.255 because the batch production records must include those records. The number of records for batch production records (and other records kept on a batch basis in table 1 of this document) equals the annual number of batches. The estimated burden for records kept by batch includes both records kept for every batch and records kept for some but not all batches. We use the annual number of batches as the number of records that will not necessarily be kept for every batch, such as test results or material review and disposition records, because such records are part of records, if they are necessary, that will be kept for every batch. FDA estimates the burden of this collection of information as follows: Table 1--Estimated Annual Recordkeeping Burden \1\ -------------------------------------------------------------------------------------------------------------------------------------------------------- Number of 21 CFR Section Number of records per Total annual Average burden per recordkeeping Total hours recordkeepers recordkeeper records -------------------------------------------------------------------------------------------------------------------------------------------------------- 111.14, Records of personnel practices, 15,000 4 60,000 1...................................... 60,000 including documentation of training. 111.23, Records of physical plant sanitation 15,000 1 15,000 0.2 (12 minutes)....................... 3,000 practices, including pest control and water quality. 111.35, Records of equipment and utensils 400 1 400 12.5................................... 5,000 calibration and sanitation practices. 111.95, Records of production and process 250 1 250 45..................................... 11,250 control systems. 111.140, Records that quality control personnel 240 1,163 279,120 1...................................... 279,120 must make and keep. 111.180, Records associated with components, 240 1,163 279,120 1...................................... 279,120 packaging, labels, and product received for packaging and labeling as a dietary supplement. 111.210, Requirements for what the master 240 1 240 2.5.................................... 600 manufacturing record must include. 111.260, Requirements for what the batch record 145 1,408 204,160 1...................................... 204,160 must include. 111.325, Records that quality control personnel 120 1 120 15..................................... 1,800 must make and keep for laboratory operations. 111.375, Records of the written procedures 260 1 260 2...................................... 520 established for manufacturing operations. 111.430, Records of the written procedures for 50 1 50 12.6................................... 630 packaging and labeling operations. 111.475, Records of product distribution and 15,000 1 15,000 0.4 (24 minutes)....................... 6,000 procedures for holding and distributing operations. 111.535, Records for returned dietary 110 4 440 13.5................................... 5,940 supplements. [[Page 66970]] 111.570, Records regarding product complaints.. 240 600 144,000 0.5 (30 minutes)....................... 72,000 -------------------------------------------------------------------------------------------------------- Total...................................... .............. .............. .............. ....................................... 929,140 -------------------------------------------------------------------------------------------------------------------------------------------------------- \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 Sec. 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 Sec. 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 Sec. 111.605, but have included those burdens under specific provisions for keeping records. For example, Sec. 111.255(a) requires that the batch production records be prepared every time a batch is manufactured, and Sec. 111.255(d) requires that batch production records be kept in accordance with Sec. 111.605. The estimated burdens for both Sec. 111.255(a) and (d) are included under Sec. 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
![Federal Register / Vol. 81, No. 189 / Thursday, September 29, 2016 / Notices 66967
DEPARTMENT OF HEALTH AND site at: http://www.acl.gov/Programs/ DEPARTMENT OF HEALTH AND
HUMAN SERVICES AIDD/Program_Resource_Search/ HUMAN SERVICES
Results_UCEDD.aspx. AIDD estimates
Administration for Community Living the burden of this collection of Food and Drug Administration
information as 1,412 average burden [Docket No. FDA–2013–N–1619]
Agency Information Collection hours per responses, for 67 UCEDDs,—
Activities; Proposed Collection; Total burden is 94,604 hours per year. Agency Information Collection
Comment Request; University Centers Activities; Proposed Collection;
Dated: September 22, 2016.
for Excellence in Developmental Comment Request; Current Good
Disabilities Education, Research, and Edwin L. Walker,
Acting Administrator. Manufacturing Practice in
Service—Annual Report Manufacturing, Packaging, Labeling, or
[FR Doc. 2016–23488 Filed 9–28–16; 8:45 am]
AGENCY: The Administration on Holding Operations for Dietary
BILLING CODE 4154–01–P
Intellectual and Developmental Supplements
Disabilities (AIDD), Administration for AGENCY: Food and Drug Administration,
Community Living (ACL), HHS. DEPARTMENT OF HEALTH AND HHS.
ACTION: Notice. HUMAN SERVICES ACTION: Notice.
SUMMARY: The Administration on Food and Drug Administration SUMMARY: The Food and Drug
Intellectual and Developmental [Docket No. FDA–2013–D–1143] Administration (FDA or we) is
Disabilities (AIDD), now part of the announcing an opportunity for public
Administration for Community Living, Use of Nucleic Acid Tests To Reduce comment on the proposed collection of
is announcing that the proposed the Risk of Transmission of West Nile certain information by the Agency.
collection of information listed below Virus From Living Donors of Human Under the Paperwork Reduction Act of
has been submitted to the Office of Cells, Tissues, and Cellular and 1995 (the PRA), Federal Agencies are
Management and Budget (OMB) for Tissue-Based Products; Guidance for required to publish notice in the
review and clearance under the Industry; Correction Federal Register concerning each
Paperwork Reduction Act of 1995. proposed collection of information,
AGENCY: Food and Drug Administration,
DATES: Submit written comments on the including each proposed extension of an
HHS.
collection of information by October 31, existing collection of information, and
ACTION: Notice of availability; to allow 60 days for public comment in
2016.
correction. response to the notice. This notice
ADDRESSES: OIRA_submission@
omb.eop.gov or by fax to 202.395.5806. SUMMARY: The Food and Drug invites comments on the information
Attn: OMB Desk Officer for ACL, Office Administration (FDA or Agency) is collection provisions of FDA’s
of Information and Regulatory Affairs, correcting a notice that appeared in the regulations regarding current good
OMB. Federal Register of Tuesday, September manufacturing practice (CGMP) for
13, 2016 (81 FR 62910). The document dietary supplements.
FOR FURTHER INFORMATION CONTACT:
announced the availability of a guidance DATES: Submit either electronic or
Ophelia McLain at 202–795–7401 written comments on the collection of
for industry entitled ‘‘Use of Nucleic
orophelia.mclain@acl.hhs.gov. information by November 28, 2016.
Acid Tests to Reduce the Risk of
SUPPLEMENTARY INFORMATION: In Transmission of West Nile Virus from ADDRESSES: You may submit comments
compliance with 44 U.S.C. 3507, the Living Donors of Human Cells, Tissues, as follows:
Administration on Intellectual and and Cellular and Tissue-Based Products
Developmental Disabilities (now part of (HCT/Ps). The document was published Electronic Submissions
the Administration for Community with incorrect information of a Submit electronic comments in the
Living) has submitted the following comment period due date. This following way:
proposed collection of information to document corrects that error. • Federal eRulemaking Portal: http://
OMB for review and clearance. FOR FURTHER INFORMATION CONTACT: www.regulations.gov. Follow the
Section 104 (42 U.S.C. 15004) of the Jonathan McKnight, Center for Biologics instructions for submitting comments.
Developmental Disabilities Assistance Evaluation and Research, Food and Comments submitted electronically,
and Bill of Rights Act of 2000 (DD Act Drug Administration, 10903 New including attachments, to http://
of 2000) directs the Secretary of Health Hampshire Ave., Bldg. 71, Rm. 7301, www.regulations.gov will be posted to
and Human Services to develop and Silver Spring, MD 20993–0002, 240– the docket unchanged. Because your
implement a system of program 402–7911. comment will be made public, you are
accountability to monitor the grantees solely responsible for ensuring that your
SUPPLEMENTARY INFORMATION: In the
funded under the DD Act of 2000. The comment does not include any
Federal Register of September 13, 2016,
program accountability system shall confidential information that you or a
in FR Doc. 2016–21969, on page 62910,
include the National Network of third party may not wish to be posted,
the following correction is made:
University Centers for Excellence in On page 62910, in the first column such as medical information, your or
Developmental Disabilities Education, under the DATES: caption, the sentence anyone else’s Social Security number, or
Research, and Service (UCEDDs) is corrected to read, ‘‘Submit either confidential business information, such
authorized under Part D of the DD Act as a manufacturing process. Please note
mstockstill on DSK3G9T082PROD with NOTICES
electronic or written comments on
of 2000. In addition to the Agency guidances at any time.’’ that if you include your name, contact
accountability system, Section 154 (e) information, or other information that
(42 U.S.C. 15064) of the DD Act of 2000 Dated: September 23, 2016.
identifies you in the body of your
includes requirements for a UCEDD Leslie Kux, comments, that information will be
Annual Report. Associate Commissioner for Policy. posted on http://www.regulations.gov.
The proposed data collection tools [FR Doc. 2016–23514 Filed 9–28–16; 8:45 am] • If you want to submit a comment
may be found on the ACL/AIDD Web BILLING CODE 4164–01–P with confidential information that you
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![66970 Federal Register / Vol. 81, No. 189 / Thursday, September 29, 2016 / Notices
TABLE 1—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1—Continued
Number of Average
Number of Total annual
21 CFR Section records per burden per Total hours
recordkeepers records
recordkeeper recordkeeping
111.570, Records regarding product complaints .............. 240 600 144,000 0.5 (30 minutes) 72,000
Total ........................................................................... ........................ ........................ ........................ ........................... 929,140
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
The average burden per recordkeeping specific provisions for keeping records. section, ‘‘October 19, 2016’’ is corrected
estimates in Table 1 of this document For example, § 111.255(a) requires that to read ‘‘October 28, 2016.’’
are based on those in the June 25, 2007, the batch production records be 2. On page 64175, in the third
final rule, which were based on our prepared every time a batch is column, the section ‘‘Transcripts: As
institutional experience with other manufactured, and § 111.255(d) requires soon as a transcript is available, FDA
CGMP requirements and on data that batch production records be kept in will post it at http://www.fda.gov/
provided by Research Triangle Institute accordance with § 111.605. The ForIndustry/UserFees/BiosimilarUser
in the ‘‘Survey of Manufacturing estimated burdens for both § 111.255(a) FeeActBsUFA/ucm461774.htm.’’ is
Practices in the Dietary Supplement and (d) are included under § 111.260, corrected to read ‘‘Transcripts: Please be
Industry’’ cited in that rule. what the batch record must include. advised that as soon as a transcript is
The estimates in table 1 of the number Dated: September 23, 2016. available, it will be accessible at http://
of firms affected by each provision of Leslie Kux,
www.regulations.gov and http://
part 111 are based on the percentage of www.fda.gov/ForIndustry/UserFees/
Associate Commissioner for Policy.
manufacturers, packagers, labelers, BiosimilarUserFeeActBsUFA/
[FR Doc. 2016–23521 Filed 9–28–16; 8:45 am] ucm461774.htm. It may be viewed at the
holders, distributors, and warehousers
BILLING CODE 4164–01–P Division of Dockets Management, Food
that reported in the survey that they
have not established written SOPs or do and Drug Administration, 5630 Fishers
not maintain records that were later Lane, Rm. 1061, Rockville, MD. A
DEPARTMENT OF HEALTH AND transcript will also be available in either
required by the June 25, 2007, final rule. HUMAN SERVICES
Because we do not have survey results hardcopy or on CD–ROM, after
for general warehouses, we entered the Food and Drug Administration submission of a Freedom of Information
approximate number of facilities in that request. The Freedom of Information
[Docket No. FDA–2015–N–3326] office address is available on the
category for those provisions covering
general facilities. For the dietary Agency’s Web site at http://
Biosimilar User Fee Act; Public www.fda.gov.’’
supplement industry, the survey Meeting; Correction
estimated that 1,460 firms would be Dated: September 23, 2016.
covered by the final rule, including AGENCY: Food and Drug Administration, Leslie Kux,
manufacturers, packagers, labelers, HHS. Associate Commissioner for Policy.
holders, distributors, and warehousers. ACTION: Notice; correction. [FR Doc. 2016–23523 Filed 9–28–16; 8:45 am]
The time estimates include the burden BILLING CODE 4164–01–P
involved in documenting that certain SUMMARY: The Food and Drug
requirements are performed and in Administration is correcting a notice
recordkeeping. We used an estimated entitled ‘‘Biosimilar User Fee Act;
Public Meeting’’ that appeared in the DEPARTMENT OF HEALTH AND
annual batch production of 1,408 HUMAN SERVICES
batches per year to estimate the burden Federal Register of September 19, 2016
of requirements that are related to the (81 FR 64171). The document Health Resources And Services
number of batches produced annually, announced a public meeting to discuss Administration
such as § 111.260, ‘‘What must the batch proposed recommendations for the
production record include?’’ The reauthorization of the Biosimilar User National Vaccine Injury Compensation
estimate of 1,408 batches per year is Fee Act (BsUFA) for fiscal years (FYs) Program; List of Petitions Received
near the midpoint of the number of 2018 through 2022. The document was
published with the incorrect date of the AGENCY: Health Resources and Services
annual batches reported by survey Administration (HRSA), Department of
firms. closure of the docket and incorrect
transcript information. This document Health and Human Services (HHS).
The length of time that CGMP records ACTION: Notice.
must be maintained is set forth in corrects those errors.
§ 111.605. Table 1 of this document FOR FURTHER INFORMATION CONTACT: Lisa SUMMARY: HRSA is publishing this
reflects the estimated burdens for Granger, Food and Drug Administration, notice of petitions received under the
written procedures, record maintenance, 10903 New Hampshire Ave., Bldg. 32, National Vaccine Injury Compensation
periodically reviewing records to Rm. 3330, Silver Spring, MD 20993– Program (the Program), as required by
determine if they may be discarded, and 0002, 301–796–9115, lisa.granger@ Section 2112(b)(2) of the Public Health
mstockstill on DSK3G9T082PROD with NOTICES
for any associated documentation for fda.hhs.gov. Service (PHS) Act, as amended. While
that activity for records that are required SUPPLEMENTARY INFORMATION: In the the Secretary of HHS (the Secretary) is
under part 111. We have not included Federal Register of Monday, September named as the respondent in all
a separate estimate of burden for those 19, 2016, in FR Doc. 2016–22442, the proceedings brought by the filing of
sections that require maintaining following corrections are made: petitions for compensation under the
records in accordance with § 111.605, 1. On page 64172, in the first column, Program, the United States Court of
but have included those burdens under in the third sentence of the DATES Federal Claims is charged by statute
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Document Created: 2016-09-29 04:14:25
Document Modified: 2016-09-29 04:14:25
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice. | |
| Dates | Submit either electronic or written comments on the collection of information by November 28, 2016. | |
| 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 66967 |
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