41364 Federal Register / Vol. 82, No. 168 / Thursday, August 31, 2017 / Proposed Rules 

List of Subjects in 18 CFR Part 11 

Dams, Electric power, Indians-lands, 

Public lands, Reporting and 

recordkeeping requirements. 

By direction of the Commission. 

Issued: August 17, 2017. 

Nathaniel J. Davis, Sr., 

Deputy Secretary. 

In consideration of the foregoing, the 

Federal Energy Regulatory Commission 

proposes to amend Part 11, Chapter I, 

Title 18, Code of Federal Regulations, as 

follows: 

PART 11—ANNUAL CHARGES UNDER 

PART I OF THE FEDERAL POWER ACT 

■ 1. The authority citation for part 11 

continues to read as follows: 

Authority: 16 U.S.C. 792–828c; 42 U.S.C. 

7101–7352. 

■ 2. In § 11.2, add paragraph (c)(1)(iv) to 

read as follows: 

* * * * * 

(c) * * * 

(1) * * * 

(iv) For all geographic areas in Alaska 

except for the Aleutian Islands Area, the 

Commission will calculate a statewide 

average per-acre land value based on the 

average per-acre land and building 

values published in the NASS Census 

for the Kenai Peninsula and the 

Fairbanks Areas. This statewide average 

per-acre value will be reduced by the 

sum of the state-specific modifier and 

seven percent. The resulting adjusted 

statewide average per-acre value will be 

applied to all projects located in Alaska, 

except for those projects located in the 

Aleutian Island Area. 

* * * * * 

[FR Doc. 2017–17846 Filed 8–30–17; 8:45 am] 

BILLING CODE 6717–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 117 

[Docket No. FDA–2016–D–2343] 

Hazard Analysis and Risk-Based 

Preventive Controls for Human Food: 

Guidance for Industry; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notification of availability. 

SUMMARY: The Food and Drug 

Administration (FDA, we, or Agency) is 

announcing the availability of another 

draft chapter of a multichapter guidance 

for industry entitled ‘‘Hazard Analysis 

and Risk-Based Preventive Controls for 

Human Food: Guidance for Industry.’’ 

This multichapter draft guidance is 

intended to explain our current thinking 

on how to comply with the 

requirements for hazard analysis and 

risk-based preventive controls under our 

rule entitled ‘‘Current Good 

Manufacturing Practice, Hazard 

Analysis, and Risk-Based Preventive 

Controls for Human Food.’’ The newly 

available draft chapter is entitled 

‘‘Chapter Six—Use of Heat Treatments 

as a Process Control.’’ 

DATES: Although you can comment on 

any guidance at any time (see 21 CFR 

10.115(g)(5)), to ensure that we consider 

your comment on this draft guidance 

before we issue the final version of the 

guidance, submit either electronic or 

written comments by February 27, 2018. 

You may submit comments as 

follows: 

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– 

2016–D–2343 for ‘‘Hazard Analysis and 

Risk-Based Preventive Controls for 

Human Food: Guidance for Industry.’’ 

Received comments will be placed in 

the docket and, except for those 

submitted as ‘‘Confidential 

Submissions,’’ publicly viewable at 

https://www.regulations.gov or at the 

Dockets Management Staff office 

between 9 a.m. and 4 p.m., Monday 

through Friday. 

• Confidential Submissions—To 

submit a comment with confidential 

information that you do not wish to be 

made publicly available, submit your 

comments only as a written/paper 

submission. You should submit two 

copies total. One copy will include the 

information you claim to be confidential 

with a heading or cover note that states 

‘‘THIS DOCUMENT CONTAINS 

CONFIDENTIAL INFORMATION.’’ The 

Agency will review this copy, including 

the claimed confidential information, in 

its consideration of comments. The 

second copy, which will have the 

claimed confidential information 

redacted/blacked out, will be available 

for public viewing and posted on 

https://www.regulations.gov. Submit 

both copies to the Dockets Management 

Staff. If you do not wish your name and 

contact information to be made publicly 

available, you can provide this 

information on the cover sheet and not 

in the body of your comments and you 

must identify this information as 

‘‘confidential.’’ Any information marked 

as ‘‘confidential’’ will not be disclosed 

except in accordance with 21 CFR 10.20 

and other applicable disclosure law. For 

more information about FDA’s posting 

of comments to public dockets, see 80 

FR 56469, September 18, 2015, or access 

the information at: https://www.gpo.gov/ 

fdsys/pkg/FR-2015-09-18/pdf/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. 

Submit written requests for single 

copies of the draft guidance to Office of 

Food Safety, Center for Food Safety and 

Applied Nutrition, Food and Drug 

Administration (HFS–300), 5001 

Campus Dr., College Park, MD 20740. 

Send two self-addressed adhesive labels 


nlaroche on DSKBBV9HB2PROD with PROPOSALS
Federal Register / Vol. 82, No. 168 / Thursday, August 31, 2017 / Proposed Rules 41365 

to assist that office in processing your 

request. See the SUPPLEMENTARY

INFORMATION section for electronic 

access to the draft guidance. 

FOR FURTHER INFORMATION CONTACT: 

Jenny Scott, Center for Food Safety and 

Applied Nutrition (HFS–300), Food and 

Drug Administration, 5001 Campus Dr., 

College Park, MD 20740, 240–402–2166. 

SUPPLEMENTARY INFORMATION: 

I. Background 

The FDA Food Safety Modernization 

Act (FSMA) (Pub. L. 111–353) enables 

FDA to better protect public health by 

helping to ensure the safety and security 

of the food supply. It enables FDA to 

focus more on preventing food safety 

problems rather than relying primarily 

on reacting to problems after they occur. 

FSMA recognizes the important role 

industry plays in ensuring the safety of 

the food supply, including the adoption 

of modern systems of preventive 

controls in food production. 

Section 103 of FSMA amended the 

Federal Food, Drug, and Cosmetic Act 

(FD&C Act), in section 418 of the FD&C 

Act (21 U.S.C. 350g), by adding 

requirements for hazard analysis and 

risk-based preventive controls for 

establishments that are required to 

register as food facilities under our 

regulations, in 21 CFR part 1, subpart H, 

in accordance with section 415 of the 

FD&C Act (21 U.S.C. 350d). We have 

established regulations to implement 

these requirements within part 117 (21 

CFR part 117). 

In the Federal Register of August 24, 

2016 (81 FR 57816), we announced the 

availability of several chapters of a 

multichapter draft guidance for industry 

entitled ‘‘Hazard Analysis and RiskBased Preventive Controls for Human 

Food.’’ We now are announcing the 

availability of an additional draft 

chapter of this multichapter guidance 

for industry. We are issuing the draft 

guidance consistent with our good 

guidance practices regulation (21 CFR 

10.115). The draft guidance, when 

finalized, will represent the current 

thinking of FDA on this topic. It does 

not establish any rights for any person 

and is not binding on FDA or the public. 

You can use an alternate approach if it 

satisfies the requirements of the 

applicable statutes and regulations. This 

guidance is not subject to Executive 

Order 12866. 

The multichapter draft guidance for 

industry is intended to explain our 

current thinking on how to comply with 

the requirements for hazard analysis 

and risk-based preventive controls 

under part 117, principally in subparts 

C and G. The chapter that we are 

announcing in this document is entitled 

‘‘Chapter Six—Use of Heat Treatments 

as a Process Control.’’ 

We intend to announce the 

availability for public comment of 

additional chapters of the draft guidance 

as we complete them. 

II. Paperwork Reduction Act of 1995 

This draft guidance refers to 

previously approved collections of 

information found in FDA regulations. 

These collections of information are 

subject to review by the Office of 

Management and Budget (OMB) under 

the Paperwork Reduction Act of 1995 

(44 U.S.C. 3501–3520). The collections 

of information in part 117 have been 

approved under OMB control number 

0910–0751. 

III. Electronic Access 

Persons with access to the Internet 

may obtain the draft guidance at either 

https://www.fda.gov/FoodGuidances or 

https://www.regulations.gov. Use the 

FDA Web site listed in the previous 

sentence to find the most current 

version of the guidance. 

Dated: August 22, 2017. 

Anna K. Abram, 

Deputy Commissioner for Policy, Planning, 

Legislation, and Analysis. 

[FR Doc. 2017–18464 Filed 8–30–17; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF LABOR 

Employee Benefits Security 

Administration 

29 CFR Part 2550 

[Application Number D–11712; D–11713; 

D–11850] 

ZRIN 1210–ZA27 

Extension of Transition Period and 

Delay of Applicability Dates; Best 

Interest Contract Exemption (PTE 

2016–01); Class Exemption for 

Principal Transactions in Certain 

Assets Between Investment Advice 

Fiduciaries and Employee Benefit 

Plans and IRAs (PTE 2016–02); 

Prohibited Transaction Exemption 84– 

24 for Certain Transactions Involving 

Insurance Agents and Brokers, 

Pension Consultants, Insurance 

Companies, and Investment Company 

Principal Underwriters (PTE 84–24) 

AGENCY: Employee Benefits Security 

Administration, Labor. 

ACTION: Notice of proposed amendments 

to PTE 2016–01, PTE 2016–02, and PTE 

84–24. 

SUMMARY: This document proposes to 

extend the special transition period 

under sections II and IX of the Best 

Interest Contract Exemption and section 

VII of the Class Exemption for Principal 

Transactions in Certain Assets Between 

Investment Advice Fiduciaries and 

Employee Benefit Plans and IRAs. This 

document also proposes to delay the 

applicability of certain amendments to 

Prohibited Transaction Exemption 84– 

24 for the same period. The primary 

purpose of the proposed amendments is 

to give the Department of Labor the time 

necessary to consider possible changes 

and alternatives to these exemptions. 

The Department is particularly 

concerned that, without a delay in the 

applicability dates, regulated parties 

may incur undue expense to comply 

with conditions or requirements that it 

ultimately determines to revise or 

repeal. The present transition period is 

from June 9, 2017, to January 1, 2018. 

The new transition period would end on 

July 1, 2019. The proposed amendments 

to these exemptions would affect 

participants and beneficiaries of plans, 

IRA owners and fiduciaries with respect 

to such plans and IRAs. 

DATES: Comments must be submitted on 

or before September 15, 2017. 

ADDRESSES: All written comments 

should be sent to the Office of 

Exemption Determinations by any of the 

following methods, identified by RIN 

1210–AB82: 

Federal eRulemaking Portal: http://

www.regulations.gov at Docket ID 

number: EBSA–2017–0004. Follow the 

instructions for submitting comments. 

Email to: 

EBSA.FiduciaryRuleExamination@

dol.gov. 

Mail: Office of Exemption 

Determinations, EBSA, (Attention: D– 

11712, 11713, 11850), U.S. Department 

of Labor, 200 Constitution Avenue NW., 

Suite 400, Washington, DC 20210. 

Hand Delivery/Courier: OED, EBSA 

(Attention: D–11712, 11713, 11850), 

U.S. Department of Labor, 122 C St. 

NW., Suite 400, Washington, DC 20001. 

Comments will be available for public 

inspection in the Public Disclosure 

Room, EBSA, U.S. Department of Labor, 

Room N–1513, 200 Constitution Avenue 

NW., Washington, DC 20210. Comments 

will also be available online at 

www.regulations.gov, at Docket ID 

number: EBSA–2017–0004 and 

www.dol.gov/ebsa, at no charge. Do not 

include personally identifiable 

information or confidential business 

information that you do not want 

publicly disclosed. Comments online 

can be retrieved by most Internet search 

engines. 


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