10107 Federal Register / Vol. 85, No. 35 / Friday, February 21, 2020 / Proposed Rules 
1Credit Reforms in Organized Wholesale Electric 
Markets, Order No. 741, 133 FERC ¶ 61,060 (2010) 
(Order No. 741), order on reh’g, Order No. 741–A, 134 FERC ¶ 61,126 (2011), reh’g denied, Order No. 741–B, 135 FERC ¶ 61,242 (2011). 
218 CFR 35.47 (2019). FTC Rule 4.10(a)(2), 16 CFR 4.10(a)(2)— 
including in particular competitively sensitive information such as costs, sales statistics, inventories, formulas, patterns, devices, manufacturing processes, or customer names. 
Comments containing material for 
which confidential treatment is requested must be filed in paper form, must be clearly labeled ‘‘Confidential,’’ and must comply with FTC Rule 4.9(c). In particular, the written request for confidential treatment that accompanies the comment must include the factual and legal basis for the request, and must identify the specific portions of the comment to be withheld from the public record. See FTC Rule 4.9(c). Your 
comment will be kept confidential only if the General Counsel grants your request in accordance with the law and the public interest. Once your comment has been posted publicly at www.regulations.gov—as legally required by FTC Rule 4.9(b)—we cannot redact or remove your comment, unless you submit a confidentiality request that meets the requirements for such treatment under FTC Rule 4.9(c), and the General Counsel grants that request. 
Visit the FTC website to read this 
request for comment and the news release describing it. The FTC Act and other laws that the Commission administers permit the collection of public comments to consider and use in this proceeding as appropriate. The Commission will consider all timely and responsive public comments that it receives on or before April 21, 2020. For information on the Commission’s privacy policy, including routine uses permitted by the Privacy Act, see https://www.ftc.gov/site-information/ privacy-policy. 
By direction of the Commission. 
April J. Tabor, 
Acting Secretary. 
[FR Doc. 2020–03447 Filed 2–20–20; 8:45 am] 
BILLING CODE 6750–01–P 
DEPARTMENT OF ENERGY 
Federal Energy Regulatory 
Commission 
18 CFR Part 35 
[Docket No. AD20–6–000] 
Request for Technical Conference and 
Petition for Rulemaking: Energy Trading Institute 
AGENCY : Federal Energy Regulatory 
Commission, Department of Energy. 
ACTION : Notice of request for technical 
conference and petition for rulemaking. SUMMARY : The Federal Energy 
Regulatory Commission has received a 
petition from the Energy Trading Institute requesting that the Commission hold a technical conference and conduct a rulemaking to update the requirements adopted in Order No. 741 and Commission’s regulations addressing credit and risk management in the markets operated by Independent System Operators and Regional Transmission Organizations. 
DATES : Comments are due March 12, 
2020. 
ADDRESSES : Comments, identified by 
docket number, may be filed in the following ways: 
•Electronic Filing through http://
www.ferc.gov. Documents created 
electronically using word processing software should be filed in native applications or print-to-PDF format and not in a scanned format. 
•Mail/Hand Delivery: Those unable 
to file electronically may mail or hand- deliver comments to: Federal Energy Regulatory Commission, Secretary of the Commission, 888 First Street NE, Washington, DC 20426. 
FOR FURTHER INFORMATION CONTACT : 
Tina Ham (Legal Information), Office of 
the General Counsel, Federal Energy Regulatory Commission, 888 First Street NE, Washington, DC 20426, Telephone: (202) 502–8887, Tina.Ham@ferc.gov. 
Michael Hill (Policy Information), Office 
of Energy Policy and Innovation, Federal Energy Regulatory Commission, 888 First Street NE, Washington, DC 20426, Telephone: (202) 502–8703, Michael.Hill@ferc.gov. 
James Burchill (Policy Information), 
Office of Energy Policy and Innovation, Federal Energy Regulatory Commission, 888 First Street NE, Washington, DC 20426, Telephone: (202) 502–6144, James.Burchill@ferc.gov. 
Anne Marie Hirschberger (Legal 
Information), Office of the General Counsel, Federal Energy Regulatory Commission, 888 First Street NE, Washington, DC 20426, Telephone: (202) 502–8387, AnneMarie.Hirschberger@ferc.gov. 
SUPPLEMENTARY INFORMATION : On 
December 16, 2019, the Energy Trading Institute filed in the above-captioned docket a petition requesting that the Commission hold a technical conference and conduct a rulemaking to update the requirements adopted in Order No. 741
1 and section 35.47 of the Commission’s regulations
2addressing credit and risk 
management in the markets operated by Independent System Operators and Regional Transmission Organizations. 
Dated: February 11, 2020. 
Kimberly D. Bose, 
Secretary. 
[FR Doc. 2020–03272 Filed 2–20–20; 8:45 am] 
BILLING CODE 6717–01–P 
DEPARTMENT OF HEALTH AND 
HUMAN SERVICES 
Food and Drug Administration 
21 CFR Part 130 
[Docket No. FDA–1995–N–0062 (Formerly 
1995N–0294)] 
RIN 0910–AC54 
Food Standards; General Principles 
and Food Standards Modernization; Reopening of the Comment Period 
AGENCY : Food and Drug Administration, 
HHS. 
ACTION : Proposed rule; reopening of the 
comment period. 
SUMMARY : The Food and Drug 
Administration (FDA or we) is reopening the comment period for the proposed rule, published in the Federal Register of May 20, 2005, entitled ‘‘Food 
Standards; General Principles and Food Standards Modernization,’’ to establish a set of general principles for food standards for FDA to use when considering whether to establish, revise, or eliminate a food standard. The proposed rule was issued jointly with the United States Department of Agriculture (USDA) and, while FDA will continue to engage with USDA regarding the proposed rule, we are reopening the comment period to receive new data, information, or further comments only on FDA-specific aspects of the proposed rule, including FDA’s 13 general principles. 
DATES : We are reopening the comment 
period on the proposed rule that published in the Federal Register of May 20, 2005 (70 FR 29214). Submit either electronic or written comments by April 21, 2020. 
ADDRESSES : 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 April 21, 2020. The https://www.regulations.gov 
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electronic filing system will accept 
comments until 11:59 p.m. Eastern Time at the end of April 21, 2020. 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. 
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– 1995–N–0062 (formerly 1995N–0294) for ‘‘General Principles and Food Standards Modernization; Reopening of the Comment Period.’’ 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.’’ FDA 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.govinfo.gov/content/pkg/FR-2015- 09-18/pdf/2015-23389.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 : 
Rumana Yasmeen, Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240–402–6060. 
SUPPLEMENTARY INFORMATION : 
I. Background on the Proposed Rule 
In the Federal Register of May 20, 
2005 (70 FR 29214), FDA and USDA jointly issued a proposed rule entitled ‘‘Food Standards; General Principles and Food Standards Modernization,’’ as a first step in instituting a process to modernize FDA definitions and standards of identity (and standards of quality and fill of container) consistent with section 401 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 341), and USDA’s definitions and standards of identity or composition under the Federal Meat Inspection Act and the Poultry Products Inspection Act (21 U.S.C. 607(c) and 457(b)) (and standards of fill of container). The proposed rule, if finalized, would establish general principles that FDA and USDA would consider when determining whether to establish, revise, or eliminate a food standard. 
Although the general principles were 
mostly consistent between FDA and USDA, a few principles were not identical. Because FDA and USDA regulate different products under different statutory authorities, some principles were developed to reflect specific FDA or USDA regulatory needs and perspectives. FDA and USDA stated that adherence to principles identified in the proposed rule would result in standards that would (1) better promote honesty and fair dealing in the interest of consumers and protect the public; (2) allow for technological advances in food production; (3) be consistent with international food standards to the extent feasible; and (4) be clear, simple, and easy to use for both manufacturers and the agencies that enforce compliance with the standards. 
The Preliminary Regulatory Impact 
Analysis (PRIA) of the proposed rule anticipated that the associated social costs of finalizing both FDA and USDA principles would be small, however would likely yield substantial benefits. The PRIA noted that: 
Standards that contain unnecessary 
elements or that fail to provide flexibility in 
terms of allowable food technology, may generate unnecessary production costs, and impede technological innovation in the food industry. Such standards may also serve as effective barriers to competition, thereby raising product prices and transferring resources from consumers to producers. Finally, some standards may be inconsistent with international standards, which may impede international trade. Impeding international trade may also restrict competition and lead to higher product prices. 
The PRIA stated that applying the 
principles set forth in the proposed rule 
could help address these issues and that the benefits of establishing the proposed principles outweighed the costs. 
Interested persons were originally 
given until August 18, 2005, to comment on these proposed general principles and to provide additional information as described in the Request for Comments section of the proposed rule. While comments received were generally supportive, FDA and USDA did not finalize the proposed rule due 
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1For more information, please visit FDA’s 
website at: https://www.fda.gov/food/workshops- 
meetings-webinars-food-and-dietary-supplements/ public-meeting-discuss-fdas-nutrition-innovation- strategy-07262018-07262018 or see the public 
docket FDA–2018–N–2381. to resource constraints and competing 
priorities. 
II. FDA Principles in the Proposed Rule 
In the proposed rule, FDA proposed a 
set of 13 general principles we would 
consider when establishing, revising, or eliminating a food standard (see 70 FR 29214 at 29234 to 29235 (proposed 21 CFR 130.5(b)). The first four general principles stated the purpose or function of a food standard and were the most fundamental principles addressing consumer economic protection. Therefore, if a food standard is inconsistent with any one of these four principles, we would consider eliminating it. The proposed rule also would revise or establish a new food standard if it was consistent with the full set of 13 principles: 
1. Promotes honesty and fair dealing 
in the interest of consumers. 
2. Describes the basic nature of the 
food to ensure that consumers are not misled by the name of the food and to meet consumers’ expectations of product characteristics and uniformity. 
3. Reflects the essential characteristics 
of the food—or those that define or distinguish a food or describe the distinctive properties of a food and that may contribute to achieving the food’s basic nature or may reflect relevant consumer expectations of a food product. 
4. Ensures food does not appear to be 
better or of a greater value than it is. May be used as a vehicle to improve the overall nutritional quality of the food supply. 
5. Contains clear and easily 
understood requirements to facilitate compliance by food manufacturers. 
6. Permits maximum flexibility in the 
technology used to prepare the food provided the technology does not alter the basic nature or essential characteristics, or adversely affect the nutritional quality or safety, of the food. Provides for any suitable, alternative manufacturing process that accomplishes the desired effect, and describes ingredients as broadly and generically as feasible. 
7. Harmonizes with international food 
standards to the extent feasible. 
8. Is simple, easy to use, and 
consistent among all food standards. Includes only those elements that are necessary to define the basic nature and essential characteristics of a particular food, without unnecessary details. 
9. Allows for variations in the 
physical attributes of the food. Where necessary to provide for specific variations in the physical attributes of a food within the standard, variations are consolidated into a single food standard. 10. Incorporates general requirements 
that pertain to multiple food standards 
of a commodity group into general regulatory provisions that address the commodity group whenever possible. 
11. Considers other relevant 
regulations. Any specific requirements for foods intended for further manufacturing are incorporated within the reference standard rather than provided as a separate standard. 
12. Provides terms that can be used to 
name a food and allows terms to be used in any order that is not misleading to consumers. 
13. Names of ingredients and 
functional use categories in a food standard should be consistent with other food standards and relevant regulations in this chapter, and, when appropriate, incorporate current scientific nomenclature. 
III. FDA’s Current Food Standards 
Modernization Efforts 
Since publication of the proposed 
rule, FDA announced our Nutrition Innovation Strategy (NIS) with the goal of helping to reduce preventable death and disease related to poor nutrition. 
The NIS focuses on, among other things, providing incentives for food manufacturers to produce products that have more healthful attributes. Under the NIS, FDA is seeking to modernize food standards in a manner that will achieve three primary goals: (1) Protect consumers against economic adulteration; (2) maintain the basic nature, essential characteristics, and nutritional integrity of food; and (3) promote industry innovation and provide flexibility to encourage manufacturers to produce more healthful foods. 
In July 2018, FDA held a public 
meeting on the NIS.
1At the meeting, we 
led a breakout session to discuss our food standards modernization goals and, among other things, to learn from stakeholders what FDA should be aware of when reviewing our food standard regulations and exploring how to modernize. At this public meeting, and in comments submitted to the public meeting docket, stakeholders expressed general support for FDA continuing its work with USDA to finalize the proposed rule. However, stakeholders also shared that, given the time that has passed since its publication, we should reopen the comment period to allow the public the opportunity to provide data and information on changes that have occurred in manufacturing, food technology, market trends, and nutrition science that FDA should consider when determining next steps for the proposed rule. 
While FDA intends to work with 
USDA if we pursue finalization of the proposed rule, for purposes of this notice we are only interested in comments, data, and information on FDA-specific aspects of the proposed rule, including the 13 general principles listed above. 
IV. Additional Issues for Consideration 
In response to stakeholder comments 
and to inform our decision regarding 
whether to proceed with finalizing the proposed rule, we seek new information and public comment on how we could create general principles for establishing new food standards and for revising or eliminating existing food standards. While FDA and USDA jointly issued the proposed rule, we are only seeking comments on the FDA-specific aspects of the proposal. We encourage comments to be as specific as possible and, when possible, to provide data and information for FDA to consider. 
While the public may comment on 
any FDA aspects of the proposed rule, we are particularly interested in comments on the following questions: 
1. Should FDA finalize the proposed 
rule? Why or why not? 
2. Are there general FDA principles 
that should be added, eliminated, revised, or retained? 
a. What is the specific principle? 
b. Why should the principle be added, 
eliminated, revised, or retained? 
c. Are there specific product examples 
that illustrate why a principle should be 
added, eliminated, revised, or retained? 
3. What specific revisions should FDA 
make to the proposed rule’s principles or framework to better reflect our modernization goals of: 
a. Protecting consumers against 
economic adulteration? 
b. Ensuring standardized foods 
continue to meet consumer expectations? 
c. Maintaining the basic nature, 
essential characteristics, and nutritional integrity of food? 
d. Promoting industry innovation? 
e. Providing flexibility to produce 
more healthful foods? 
f. Facilitating additional flexibility 
across all or broad categories of 
standardized foods? 
4. How should FDA weigh the general 
principles? 
a. The proposed rule stated that the 
first four principles were the most fundamental to addressing consumer 
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economic protection and therefore, FDA 
would consider eliminating a food standard if it is inconsistent with any of these four principles. 
i. Please explain whether you agree 
with this framework. 
ii. If you do not agree, what principles 
should FDA consider when deciding whether to eliminate a food standard? 
b. The proposed rule explained that 
FDA would consider revising or establishing a new food standard only if it was consistent with all 13 principles. 
i. Please explain whether you agree 
with this framework. 
ii. If you do not agree, what principles 
should FDA consider when deciding whether to revise or establish a new food standard? 
5. What explanation is needed to 
provide more clarity, certainty, or context regarding: 
a. The rationale for the principles? b. How FDA will consider the 
principles when evaluating whether to eliminate, revise, or establish a new food standard? 
c. How stakeholders should use the 
principles to inform the preparation of petitions requesting that FDA eliminate, revise, or establish a new food standard? 
6. What additional information 
should FDA consider when evaluating the costs, benefits, and estimates of the annual reporting burden of the proposed rule? 
Dated: February 13, 2020. 
Lowell J. Schiller, 
Principal Associate Commissioner for Policy. 
[FR Doc. 2020–03437 Filed 2–20–20; 8:45 am] 
BILLING CODE 4164–01–P 
DEPARTMENT OF HEALTH AND 
HUMAN SERVICES 
Food and Drug Administration 
21 CFR Part 866 
[Docket No. FDA–2019–N–5192] 
Microbiology Devices; Reclassification 
of Human Immunodeficiency Virus Serological Diagnostic and Supplemental Tests and Human Immunodeficiency Virus Nucleic Acid Diagnostic and Supplemental Tests 
AGENCY : Food and Drug Administration, 
HHS. 
ACTION : Proposed amendment; proposed 
order. 
SUMMARY : The Food and Drug 
Administration (FDA or the Agency) is proposing to reclassify certain human immunodeficiency virus (HIV) serological diagnostic and supplemental tests and HIV nucleic acid (NAT) diagnostic and supplemental tests, postamendments class III devices with the product code MZF, into class II (special controls), subject to premarket notification. FDA is also proposing new device classification regulations along with special controls that the Agency believes are necessary to provide a reasonable assurance of safety and effectiveness for these devices. FDA is proposing this reclassification on its own initiative. If finalized, this order will reclassify these types of devices from class III (premarket approval) to class II (special controls) and reduce the regulatory burdens associated with these devices, as these types of devices will no longer be required to submit a premarket approval application (PMA) but can instead submit a premarket notification (510(k)) and receive clearance before marketing their device. 
DATES : Submit either electronic or 
written comments by April 21, 2020. Please see section XI of this document for the proposed effective date when the new requirements apply and for the proposed effective date of a final order based on this proposed order. 
ADDRESSES : 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 April 21, 2020. The https://www.regulations.gov electronic filing system will accept comments until 11:59 p.m. Eastern Time at the end of April 21, 2020. 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. 
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 below (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– 
2019–N–5192 for ‘‘Microbiology Devices; Reclassification of human immunodeficiency virus serological diagnostic and supplemental tests and human immunodeficiency virus nucleic acid diagnostic and supplemental tests’’. 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 
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