81 FR 48816 - Agency Information Collection Activities; Proposed Collection; Comment Request; Procedures for the Safe and Sanitary Processing and Importing of Fish and Fishery Products
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 81, Issue 143 (July 26, 2016)
Food and Drug Administration
Federal Register Volume 81, Issue 143 (July 26, 2016)
| Page Range | 48816-48819 | |
| FR Document | 2016-17571 |
[Federal Register Volume 81, Number 143 (Tuesday, July 26, 2016)] [Notices] [Pages 48816-48819] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-17571] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-N-0879] Agency Information Collection Activities; Proposed Collection; Comment Request; Procedures for the Safe and Sanitary Processing and Importing of Fish and Fishery Products 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 our regulations requiring reporting and recordkeeping for processors and importers of fish and fishery products. DATES: Submit either electronic or written comments on the collection of information by September 26, 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 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-0879 for ``Agency Information Collection Activities; Proposed Collection; Comment Request; Procedures for the Safe and Sanitary Processing and Importing of Fish and Fishery Products.'' 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 [[Page 48817]] 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, PRAStaff@fda.hhs.gov. SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal Agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. ``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes Agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal Agencies to provide a 60-day notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, before submitting the collection to OMB for approval. To comply with this requirement, FDA is publishing notice of the proposed collection of information set forth in this document. With respect to the following collection of information, FDA invites comments on these topics: (1) Whether the proposed collection of information is necessary for the proper performance of FDA's functions, including whether the information will have practical utility; (2) the accuracy of FDA's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) 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. Procedures for the Safe and Sanitary Processing and Importing of Fish and Fishery Products--21 CFR Part 123 OMB Control Number 0910-0354--Extension FDA regulations in part 123 (21 CFR part 123) mandate the application of hazard analysis and critical control point (HACCP) principles to the processing of seafood. HACCP is a preventive system of hazard control designed to help ensure the safety of foods. The regulations were issued under FDA's statutory authority to regulate food safety, including section 402(a)(1) and (4) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 342(a)(1) and (4)). Certain provisions in part 123 require that processors and importers of seafood collect and record information. The HACCP records compiled and maintained by a seafood processor primarily consist of the periodic observations recorded at selected monitoring points during processing and packaging operations, as called for in a processor's HACCP plan (e.g., the values for processing times, temperatures, acidity, etc., as observed at critical control points). The primary purpose of HACCP records is to permit a processor to verify that products have been produced within carefully established processing parameters (critical limits) that ensure that hazards have been avoided. HACCP records are normally reviewed by appropriately trained employees at the end of a production lot or at the end of a day or week of production to verify that control limits have been maintained, or that appropriate corrective actions were taken if the critical limits were not maintained. Such verification activities are essential to ensure that the HACCP system is working as planned. A review of these records during the conduct of periodic plant inspections also permits FDA to determine whether the products have been consistently processed in conformance with appropriate HACCP food safety controls. Section 123.12 requires that importers of seafood products take affirmative steps and maintain records that verify that the fish and fishery products they offer for import into the United States were processed in accordance with the HACCP and sanitation provisions set forth in part 123. These records are also to be made available for review by FDA as provided in Sec. 123.12(c). The time and costs of these recordkeeping activities will vary considerably among processors and importers of fish and fishery products, depending on the type and number of products involved, and on the nature of the equipment or instruments required to monitor critical control points. The burden estimate in table 1 includes only those collections of information under the seafood HACCP regulations that are not already required under other statutes and regulations. The estimate also does not include collections of information that are a usual and customary part of businesses' normal activities. For example, the tagging and labeling of molluscan shellfish (21 CFR 1240.60) is a customary and usual practice among seafood processors. Consequently, the estimates in table 1 account only for information collection and recording requirements attributable to part 123. Description of respondents: Respondents to this collection of information include processors and importers of seafood. FDA estimates the burden of this collection of information as follows: [[Page 48818]] Table 1--Estimated Annual Reporting Burden \1\ ---------------------------------------------------------------------------------------------------------------- Number of Number of records per Total annual Average burden per 21 CFR Section \2\ recordkeepers recordkeeper records recordkeeping \4\ Total hours \3\ ---------------------------------------------------------------------------------------------------------------- 123.6(a), (b), and (c); 50 1 50 16 800 Prepare hazard analysis and HACCP plan................. 123.6(c)(5); Undertake and 15,000 4 60,000 .30 18,000 prepare records of (18 minutes) corrective actions......... 123.8(a)(1) and (c); 15,000 1 15,000 4 60,000 Reassess hazard analysis and HACCP plan............. 123.12(a)(2)(ii); Verify 4,100 80 328,000 .20 65,600 compliance of imports and (12 minutes) prepare records of verification activities.... 123.6(c)(7); Document 15,000 280 4,200,000 .30 1,260,000 monitoring of critical (18 minutes) control points............. 123.7(d); Undertake and 6,000 4 24,000 .10 2,400 prepare records of (6 minutes) corrective actions due to a deviation from a critical limit...................... 123.8(d); Maintain records 15,000 47 705,000 .10 70,500 of the calibration of (6 minutes) process-monitoring instruments and the performing of any periodic end-product and in-process testing.................... 123.11(c); Maintain 15,000 280 4,200,000 .10 420,000 sanitation control records. (6 minutes) 123.12(c); Maintain records 4,100 80 328,000 .10 32,800 that verify that the fish (6 minutes) and fishery products they offer for import into the United States were processed in accordance with the HACCP and sanitation provisions set forth in part 123.......... 123.12(a)(2); Prepare new 41 1 41 4 164 written verification procedures to verify compliance of imports...... ----------------------------------------------------------------------------------- Total................... .............. .............. .............. .................. 1,930,264 ---------------------------------------------------------------------------------------------------------------- \1\ There are no capital costs or operating and maintenance costs associated with this collection of information. \2\ These estimates include the information collection requirements in the following sections: Sec. 123.16--Smoked Fish--process controls (see Sec. 123.6(b)); Sec. 123.28(a)--Source Controls--molluscan shellfish (see Sec. 123.6(b)); Sec. 123.28(c) and (d)--Records--molluscan shellfish (see Sec. 123.6(c)(7)). \3\ Based on an estimated 280 working days per year. \4\ Estimated average time per 8-hour work day unless one-time response. We base this hour burden estimate on our experience with the application of HACCP principles in food processing. Further, the burdens have been estimated using typical small seafood processing firms as a model because these firms represent a significant proportion of the industry. The hour burden of HACCP recordkeeping activities will vary considerably among processors and importers of fish and fishery products, depending on the size of the facility and complexity of the HACCP control scheme (i.e., the number of products and the number of hazards controlled); the daily frequency that control points are monitored and values recorded; and also on the extent that data recording time and cost are minimized by the use of automated data logging technology. The burden estimate does not include burden hours for activities that are a usual and customary part of businesses' normal activities. For example, the tagging and labeling of molluscan shellfish (Sec. 1240.60) is a customary and usual practice among seafood processors. Based on our records, we estimate that there are 15,000 processors and 4,100 importers. We estimate that 50 processors will undertake the initial preparation of a hazard analysis and HAACP plan (Sec. 123.6(a), (b), and (c)). We estimate the burden for the initial preparation of a hazard analysis and HAACP plan to be 16 hours per processor for a total burden of 800 hours. We estimate that all processors (15,000 processors) will undertake and keep records of four corrective action plans (Sec. 123.6(c)(5)) for a total of 60,000 records. We estimate the burden for the preparation of each record to be .30 hours for a total burden of 18,000 hours. We estimate that all processors (15,000 processors) will annually reassess their hazard analysis and HACCP plan (Sec. 123.8(a)(1) and (c)). We estimate the burden for the reassessment of the hazard analysis and HAACP plan to be 4 hours per processor for a total burden of 60,000 hours. We estimate that all importers (4,100 importers) will take affirmative steps to verify compliance of imports and prepare 80 records of their verification activities (Sec. 123.12(a)(2)(ii)) for a total of 328,000 records. We estimate the burden for the preparation of each record to be .20 hours for a total burden of 65,600 hours. We estimate that all processors (15,000 processors) will document the monitoring of critical control points (Sec. 123.6(c)(7)) at 280 records per processor for a total of 4,200,000 records. We estimate the burden for the preparation of each record to be .30 hours for a total burden of 1,260,000 hours. We estimate that 40 percent of all processors (6,000 processors) will maintain records of any corrective actions taken due to a deviation from a critical limit (Sec. 123.7(d) at 4 records per processor for a total of 24,000 records. [[Page 48819]] We estimate the burden for the preparation of each record to be .10 hours for a total burden of 2,400 hours. We estimate that all processors (15,000 processors) will maintain records of the calibration of process-monitoring instruments and the performing of any periodic end-product and in-process testing (Sec. 123.8(d)) at 47 records per processor for a total of 705,000 records. We estimate the burden for the preparation of each record to be .10 hours for a total burden of 70,500 hours. We estimate that all processors (15,000 processors) will maintain sanitation control records (Sec. 123.11(c)) at 280 records per processor for a total of 4,200,000 records. We estimate the burden for the preparation of each record to be .10 hours for a total burden of 420,000 hours. We estimate that all importers (4,100 importers) will maintain records that verify that the fish and fishery products they offer for import into the United States were processed in accordance with the HACCP and sanitation provisions set forth in part 123 (Sec. 123.12(c)). We estimate that 80 records will be prepared per importer for a total of 328,000 records. We estimate the burden for the preparation of each record to be .10 hours for a total burden of 32,800 hours. We estimate that 1 percent of all importers (41 importers) will require new written verification procedures to verify compliance of imports (Sec. 123.12(a)(2)). We estimate the burden for preparing the new procedures to be 4 hours per importer for a total burden of 164 hours. Dated: July 19, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016-17571 Filed 7-25-16; 8:45 am] BILLING CODE 4164-01-P
![48816 Federal Register / Vol. 81, No. 143 / Tuesday, July 26, 2016 / Notices
accredited issuing agencies, and consist request to CDRH-Guidance@fda.hhs.gov ADDRESSES: You may submit comments
of a specific set of characters used to or ocod@fda.hhs.gov, or by calling 1– as follows:
identify the information immediately 800–835–4709 or 240–402–7800, to
Electronic Submissions
following the data delimiter. receive an electronic copy of the
For purposes of this draft guidance, document. Please use the document Submit electronic comments in the
we define ‘‘UDI carrier’’ as the means to number GUD1500035 to identify the following way:
convey the UDI and any non-UDI guidance you are requesting. • Federal eRulemaking Portal: http://
elements by using easily readable plain- www.regulations.gov. Follow the
text and AIDC forms. In the UDI carrier, V. Paperwork Reduction Act of 1995 instructions for submitting comments.
the data represented in the UDI should This draft guidance refers to Comments submitted electronically,
precede any non-UDI elements and previously approved collections of including attachments, to http://
should be distinguishable from the UDI information described in FDA www.regulations.gov will be posted to
elements. The easily readable plain-text regulations. These collections of the docket unchanged. Because your
form of the UDI should be ordered to information are subject to review by the comment will be made public, you are
specify the DI first, followed by the PIs. Office of Management and Budget solely responsible for ensuring that your
If there are any non-UDI elements in the (OMB) under the Paperwork Reduction comment does not include any
UDI carrier, the non-UDI elements Act of 1995 (44 U.S.C. 3501–3520). The confidential information that you or a
should follow the PIs that are part of the collections of information in 21 CFR third party may not wish to be posted,
UDI. For more information on non-UDI part 801 have been approved under such as medical information, your or
elements capable of being included in OMB control number 0910–0485, and anyone else’s Social Security number, or
the UDI carrier, labelers should contact the collections of information in 21 CFR confidential business information, such
their FDA-accredited issuing agency. part 830 have been approved under as a manufacturing process. Please note
OMB control number 0910–0720. that if you include your name, contact
II. Significance of Guidance
information, or other information that
This draft guidance is being issued Dated: July 20, 2016.
identifies you in the body of your
consistent with FDA’s good guidance Leslie Kux,
comments, that information will be
practices regulation (21 CFR 10.115). Associate Commissioner for Policy. posted on http://www.regulations.gov.
The draft guidance, when finalized, will [FR Doc. 2016–17554 Filed 7–25–16; 8:45 am] • If you want to submit a comment
represent the current thinking of FDA BILLING CODE 4164–01–P with confidential information that you
on ‘‘Unique Device Identification do not wish to be made available to the
System: Form and Content of the public, submit the comment as a
Unique Device Identifier (UDI)’’. It does DEPARTMENT OF HEALTH AND written/paper submission and in the
not establish any rights for any person HUMAN SERVICES manner detailed (see ‘‘Written/Paper
and is not binding on FDA or the public. Submissions’’ and ‘‘Instructions’’).
You can use an alternative approach if Food and Drug Administration
it satisfies the requirements of the Written/Paper Submissions
[Docket No. FDA–2013–N–0879]
applicable statutes and regulations. Submit written/paper submissions as
Agency Information Collection follows:
III. Request for Comments Activities; Proposed Collection; • Mail/Hand delivery/Courier (for
FDA is seeking additional information Comment Request; Procedures for the written/paper submissions): Division of
on this issue. FDA is particularly Safe and Sanitary Processing and Dockets Management (HFA–305), Food
interested in receiving information Importing of Fish and Fishery Products and Drug Administration, 5630 Fishers
relating to the following question: Are Lane, Rm. 1061, Rockville, MD 20852.
there any additional standards, in AGENCY: Food and Drug Administration, • For written/paper comments
addition to those referenced in this draft HHS. submitted to the Division of Dockets
guidance, that should be used to ACTION: Notice. Management, FDA will post your
determine the print quality of the AIDC comment, as well as any attachments,
form of the UDI? SUMMARY: The Food and Drug except for information submitted,
Administration (FDA or we) is marked and identified, as confidential,
IV. Electronic Access announcing an opportunity for public if submitted as detailed in
Persons interested in obtaining a copy comment on the proposed collection of ‘‘Instructions.’’
of the draft guidance may do so by certain information by the Agency. Instructions: All submissions received
downloading an electronic copy from Under the Paperwork Reduction Act of must include the Docket No. FDA–
the Internet. A search capability for all 1995 (the PRA), Federal Agencies are 2013–N–0879 for ‘‘Agency Information
Center for Devices and Radiological required to publish notice in the Collection Activities; Proposed
Health guidance documents is available Federal Register concerning each Collection; Comment Request;
at http://www.fda.gov/MedicalDevices/ proposed collection of information, Procedures for the Safe and Sanitary
DeviceRegulationandGuidance/ including each proposed extension of an Processing and Importing of Fish and
GuidanceDocuments/default.htm or at existing collection of information, and Fishery Products.’’ Received comments
http://www.fda.gov/ to allow 60 days for public comment in will be placed in the docket and, except
BiologicsBloodVaccines/ response to the notice. This notice for those submitted as ‘‘Confidential
GuidanceComplianceRegulatory invites comments on the information Submissions,’’ publicly viewable at
srobinson on DSK5SPTVN1PROD with NOTICES
Information/default.htm. Guidance collection provisions of our regulations http://www.regulations.gov or at the
documents are also available at http:// requiring reporting and recordkeeping Division of Dockets Management
www.regulations.gov. Persons unable to for processors and importers of fish and between 9 a.m. and 4 p.m., Monday
download an electronic copy of fishery products. through Friday.
‘‘Unique Device Identification System: DATES: Submit either electronic or • Confidential Submissions—To
Form and Content of the Unique Device written comments on the collection of submit a comment with confidential
Identifier (UDI)’’ may send an email information by September 26, 2016. information that you do not wish to be
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![Federal Register / Vol. 81, No. 143 / Tuesday, July 26, 2016 / Notices 48819
We estimate the burden for the reflect on the past, present, and future during the meeting that are responsive
preparation of each record to be .10 impact of national bioethics advisory to specific sessions. Written comments
hours for a total burden of 2,400 hours. bodies. Topics will include the history will be accepted in advance, during, and
We estimate that all processors of national bioethics advisory bodies after the meeting and are especially
(15,000 processors) will maintain and their contributions to health policy, welcome. Comments will be publicly
records of the calibration of process- perspectives about similar bodies available, including any personally
monitoring instruments and the elsewhere, and discussion about what identifiable or confidential business
performing of any periodic end-product the future holds for groups like the information that they contain. Trade
and in-process testing (§ 123.8(d)) at 47 Commission. secrets should not be submitted.
records per processor for a total of DATES: The meeting will take place Written comments will be accepted by
705,000 records. We estimate the August 31, 2016, from 9 a.m. to email to info@bioethics.gov, or by mail
burden for the preparation of each approximately 4 p.m. to the following address: Public
record to be .10 hours for a total burden ADDRESSES: Annenberg Public Policy Commentary, Presidential Commission
of 70,500 hours. Center, 202 S. 36th St., Philadelphia, PA for the Study of Bioethical Issues, 330
We estimate that all processors C Street SW., Suite L001, Washington,
19104.
(15,000 processors) will maintain DC 20201. To accommodate as many
FOR FURTHER INFORMATION CONTACT: Lisa
sanitation control records (§ 123.11(c)) individuals as possible, the time for
at 280 records per processor for a total M. Lee, Executive Director, Presidential
Commission for the Study of Bioethical each question or comment may be
of 4,200,000 records. We estimate the limited. If the number of individuals
burden for the preparation of each Issues, 330 C Street SW., Suite L001,
Washington, DC 20201. Telephone: wishing to pose a question or make a
record to be .10 hours for a total burden comment is greater than can reasonably
of 420,000 hours. 202–795–7689. Email: Lisa.Lee@
bioethics.gov. Additional information be accommodated during the scheduled
We estimate that all importers (4,100 meeting, the Commission may make a
importers) will maintain records that may be obtained at www.bioethics.gov.
SUPPLEMENTARY INFORMATION: Pursuant random selection. Time permitting, we
verify that the fish and fishery products will read aloud as many comments as
they offer for import into the United to the Federal Advisory Committee Act
of 1972, Public Law 92–463, 5 U.S.C. possible.
States were processed in accordance
app. 2, notice is hereby given of the Anyone planning to attend the
with the HACCP and sanitation
twenty-sixth meeting of the meeting who needs special assistance,
provisions set forth in part 123
Commission. The meeting will be open such as sign language interpretation or
(§ 123.12(c)). We estimate that 80
to the public with attendance limited to other reasonable accommodations,
records will be prepared per importer
space available. The meeting will also should notify Esther Yoo by telephone
for a total of 328,000 records. We
be webcast at www.bioethics.gov. at (202) 795–7689, or email at
estimate the burden for the preparation
Under authority of Executive Order Esther.Yoo@bioethics.gov at least one
of each record to be .10 hours for a total
13521, dated November 24, 2009, the week in advance of the meeting. The
burden of 32,800 hours.
We estimate that 1 percent of all President established the Commission. Commission will make every effort to
importers (41 importers) will require The Commission is an expert panel of accommodate persons who need special
new written verification procedures to not more than 13 members who are assistance.
verify compliance of imports drawn from the fields of bioethics, Dated: July 8, 2016.
(§ 123.12(a)(2)). We estimate the burden science, medicine, technology, Lisa M. Lee,
for preparing the new procedures to be engineering, law, philosophy, theology, Executive Director, Presidential Commission
4 hours per importer for a total burden or other areas of the humanities or for the Study of Bioethical Issues.
of 164 hours. social sciences. The Commission [FR Doc. 2016–17620 Filed 7–25–16; 8:45 am]
advises the President on bioethical
Dated: July 19, 2016. issues arising from advances in
BILLING CODE 4154–06–P
Leslie Kux, biomedicine and related areas of science
Associate Commissioner for Policy. and technology. The Commission seeks DEPARTMENT OF HEALTH AND
[FR Doc. 2016–17571 Filed 7–25–16; 8:45 am] to identify and promote policies and HUMAN SERVICES
BILLING CODE 4164–01–P practices that ensure scientific research,
health care delivery, and technological National Institutes of Health
innovation are conducted in a socially
DEPARTMENT OF HEALTH AND and ethically responsible manner. National Institute of General Medical
HUMAN SERVICES The main agenda for the Sciences; Notice of Closed Meetings
Commission’s twenty-sixth meeting is to
Public Meeting of the Presidential reflect upon the role of national Pursuant to section 10(d) of the
Commission for the Study of bioethics advisory bodies, both in the Federal Advisory Committee Act, as
Bioethical Issues US and abroad, in the past, present, and amended (5 U.S.C. App.), notice is
AGENCY: Presidential Commission for future. hereby given of the following meetings.
the Study of Bioethical Issues, Office of The Commission welcomes input The meetings will be closed to the
the Assistant Secretary for Health, from anyone wishing to provide public public in accordance with the
Office of the Secretary, Department of comment on any issue before it. provisions set forth in sections
Respectful consideration of opposing 552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
srobinson on DSK5SPTVN1PROD with NOTICES
Health and Human Services.
ACTION: Notice of meeting. views and active participation by as amended. The grant applications and
citizens in public exchange of ideas the discussions could disclose
SUMMARY: The Presidential Commission enhances overall public understanding confidential trade secrets or commercial
for the Study of Bioethical Issues (the of the issues at hand and conclusions property such as patentable material,
Commission) will conduct its twenty- reached by the Commission. The and personal information concerning
sixth meeting on August 31, 2016. At Commission is particularly interested in individuals associated with the grant
this meeting, the Commission will receiving comments and questions applications, the disclosure of which
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Document Created: 2018-02-08 08:00:48
Document Modified: 2018-02-08 08:00:48
| 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 September 26, 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 48816 |
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