Federal Register / Vol. 83, No. 110 / Thursday, June 7, 2018 / Notices 26475 

TABLE 2—NEW ENTRIES TO THE LIST OF RECOGNIZED STANDARDS—Continued 

Recognition No. Title of standard 1 Reference No. and Date 

O. Physical Medicine 

16–202 ............... RESNA Standard for Wheelchairs Volume 4: Wheelchairs and Transportation ...................... RESNA WC–4:2017. 

P. Radiology 

No new entries at this time 

Q. Software/Informatics 

13–104 ............... Software Cybersecurity for Network-Connectable Products, Part 2–1: Particular Requirements for Network Connectable Components of Healthcare and Wellness Systems.ANSI/UL 2900–2–1, First Edition September 1, 2017. 

R. Sterility 

No new entries at this time 

S. Tissue Engineering 

15–53 ................. Standard Guide for Assessing Medical Device Cytocompatibility with Delivered Cellular 

Therapies.

ASTM F3206 –17. 

15–54 ................. Standard Guide for in vivo Evaluation of Rabbit Lumbar Intertransverse Process Spinal Fusion Model.ASTM F3207–17. 

1All standard titles in this table conform to the style requirements of the respective organizations. 

IV. List of Recognized Standards 

FDA maintains the current list of FDA 

Recognized Consensus Standards in a 

searchable database that may be 

accessed at https://

www.accessdata.fda.gov/scripts/cdrh/ 

cfdocs/cfStandards/search.cfm. FDA 

will be incorporating the modifications 

and revisions described in this notice 

into the database and, upon publication 

in the Federal Register, this recognition 

of consensus standards will be effective. 

FDA will be announcing additional 

modifications and revisions to the list of 

recognized consensus standards, as 

needed, in the Federal Register once a 

year, or more often if necessary. 

Beginning with recognition list 049, 

FDA will no longer include in the 

database the CDRH Office and Division 

associated with recognized standards, 

Devices Affected, and Processes 

Affected. Beginning with recognition 

list 049 FDA will automatically 

incorporate, upon publication, a U.S. 

parallel adoption of an existing 

recognized international standard. 

V. Recommendation of Standards for 

Recognition by FDA 

Any person may recommend 

consensus standards as candidates for 

recognition under section 514 of the 

FD&C Act by submitting such 

recommendations, with reasons for the 

recommendation, to 

CDRHStandardsStaff@fda.hhs.gov. To 

be considered, such recommendations 

should contain, at a minimum, the 

following information available at 

https://www.fda.gov/MedicalDevices/ 

DeviceRegulationandGuidance/ 

Standards/ucm123739.htm. 

Dated: May 31, 2018. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2018–12222 Filed 6–6–18; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2018–D–1635] 

Prescription Drug User Fee Act 

Waivers for Fixed-Combination 

Antiretroviral Drugs for the President’s 

Emergency Plan for AIDS Relief; Draft 

Guidance for Industry; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of availability. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

announcing the availability of a draft 

guidance for industry entitled 

‘‘Prescription Drug User Fee Act 

Waivers for Fixed-Combination 

Antiretroviral Drugs for the President’s 

Emergency Plan for AIDS Relief.’’ This 

draft guidance describes circumstances 

under which an applicant may be 

eligible for a barrier-to-innovation 

waiver for some new drug applications 

(NDAs) for fixed-combination versions 

and single-entity versions of previously 

approved antiretroviral therapies for the 

treatment of human immunodeficiency 

virus (HIV). 

DATES: Submit either electronic or 

written comments on the guidance 

August 6, 2018 to ensure that the 

Agency considers your comment on this 

draft guidance before it begins work on 

the final version of the guidance. 

ADDRESSES: You may submit comments 

on any guidance at any time 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 


sradovich on DSK3GMQ082PROD with NOTICES
26476 Federal Register / Vol. 83, No. 110 / Thursday, June 7, 2018 / Notices 

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– 

2018–D–1635 for ‘‘Prescription Drug 

User Fee Act Waivers for FixedCombination Antiretroviral Drugs for 

the President’s Emergency Plan for 

AIDS Relief.’’ 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 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. 

You may submit comments on any 

guidance at any time (see 21 CFR 

10.115(g)(5)). 

Submit written requests for single 

copies of the draft guidance to the 

Division of Drug Information, Center for 

Drug Evaluation and Research, Food 

and Drug Administration, 10001 New 

Hampshire Ave., Hillandale Building, 

4th Floor, Silver Spring, MD 20993– 

0002. Send one self-addressed adhesive 

label to assist that office in processing 

your requests. See the SUPPLEMENTARY

INFORMATION section for electronic 

access to the draft guidance document. 

FOR FURTHER INFORMATION CONTACT: Ted 

Palat, Center for Drug Evaluation and 

Research, Food and Drug 

Administration, 10001 New Hampshire 

Ave., Rm. 2185, Silver Spring, MD 

20993, 240–402–8739, Ted.Palat@

fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a draft guidance for industry entitled 

‘‘Prescription Drug User Fee Act 

Waivers for Fixed-Combination 

Antiretroviral Drugs for the President’s 

Emergency Plan for AIDS Relief.’’ The 

draft guidance describes the 

circumstances under which certain 

applications for fixed-combination and 

single-entity versions of previously 

approved antiretroviral therapies for the 

treatment of HIV under the President’s 

Emergency Plan for AIDS Relief 

(PEPFAR) may be eligible for a barrierto-innovation waiver. 

In October 2006, to encourage 

applicants to submit applications for 

HIV combination therapies that can be 

used in PEPFAR, FDA issued a final 

guidance entitled ‘‘Fixed Dose 

Combinations, Co-Packaged Drug 

Products, and Single-Entity Versions of 

Previously Approved Antiretrovirals for 

the Treatment of HIV’’ (fixedcombination guidance). Attachments to 

the fixed-combination guidance 

describe some scenarios for approval of 

fixed-combination for the treatment of 

HIV and provide examples of drug 

combinations considered acceptable as 

fixed combinations and examples of 

those not considered acceptable as fixed 

combinations. Although the 2006 fixedcombination guidance focuses on fixed 

combinations, the scientific principles 

outlined in the guidance also apply to 

single ingredient versions of 

antiretroviral drugs that are components 

of regimens listed in Attachment B. The 

guidance also explains that the Federal 

Food, Drug, and Cosmetic Act (FD&C 

Act) provides for certain circumstances 

in which FDA may grant a waiver or 

reduction in user fees. 

This draft guidance is a revision of the 

guidance for industry entitled ‘‘User Fee 

Waivers for FDC and Co-Packaged HIV 

Drugs for PEPFAR,’’ issued February 

2007. In this guidance, FDA provides 

information about the circumstances 

under which certain applications for 

fixed-combination and single-entity 

versions of previously approved 

antiretroviral therapies for the treatment 

of HIV under PEPFAR may be eligible 

for a barrier-to-innovation waiver. 

This draft guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The draft guidance, when finalized, will 

represent the current thinking of FDA 

on ‘‘Prescription Drug User Fee Act 

Waivers for Fixed-Combination 

Antiretroviral Drugs for the President’s 

Emergency Plan for AIDS Relief.’’ It 

does not establish any rights for any 

person and is not binding on FDA or the 

public. You can use an alternative 

approach if it satisfies the requirements 

of the applicable statutes and 

regulations. This guidance is not subject 

to Executive Order 12866. 

II. Paperwork Reduction Act of 1995 

This draft guidance contains 

information collection provisions that 

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 burden of 

information collection associated with 

requesting waivers of user fees 

(including PEPFAR waivers) was 

previously approved under OMB 

control number 0910–0693. The burden 

for completing and submitting Form 

FDA 3397 (Prescription Drug User Fee 

Coversheet) is not included in this 

analysis as the burden is already 

approved under OMB control number 

0910–0297. The collections of 

information associated with submission 

of a new drug application or biologics 

license application are approved under 

OMB control numbers 0910–0001 and 

0910–0338, respectively. 

III. Electronic Access 

Persons with access to the internet 

may obtain the draft guidance at either 

https://www.fda.gov/Drugs/ 


sradovich on DSK3GMQ082PROD with NOTICES
Federal Register / Vol. 83, No. 110 / Thursday, June 7, 2018 / Notices 26477 

GuidanceComplianceRegulatory

Information/Guidances/default.htm or 

https://www.regulations.gov. 

Dated: June 1, 2018. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2018–12217 Filed 6–6–18; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2011–N–0781] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Record Retention 

Requirements for the Soy Protein and 

Risk of Coronary Heart Disease Health 

Claim 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing 

that a proposed collection of 

information has been submitted to the 

Office of Management and Budget 

(OMB) for review and clearance under 

the Paperwork Reduction Act of 1995 

(PRA). 

DATES: Fax written comments on the 

collection of information by July 9, 

2018. 

ADDRESSES: To ensure that comments on 

the information collection are received, 

OMB recommends that written 

comments be faxed to the Office of 

Information and Regulatory Affairs, 

OMB, Attn: FDA Desk Officer, Fax: 202– 

395–7285, or emailed to oira_

submission@omb.eop.gov. All 

comments should be identified with the 

OMB control number 0910–0428. Also 

include the FDA docket number found 

in brackets in the heading of this 

document. 

FOR FURTHER INFORMATION CONTACT: 

JonnaLynn Capezzuto, Office of 

Operations, Food and Drug 

Administration, Three White Flint 

North, 10A–12M, 11601 Landsdown St., 

North Bethesda, MD 20852, 301–796– 

3794, PRAStaff@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: In 

compliance with 44 U.S.C. 3507, FDA 

has submitted the following proposed 

collection of information to OMB for 

review and clearance. 

Record Retention Requirements for the 

Soy Protein and Risk of Coronary Heart 

Disease Health Claim—21 CFR 101.82 

OMB Control Number 0910–0428— 

Extension 

Section 403(r)(3)(A) of the Federal 

Food, Drug, and Cosmetic Act (21 U.S.C. 

343(r)(3)(A)) provides for the use of food 

label statements characterizing a 

relationship of any nutrient of the type 

required to be in the label or labeling of 

the food to a disease or a health-related 

condition only where that statement 

meets the requirements of the 

regulations issued by the Secretary of 

Health and Human Services to authorize 

the use of such a health claim. Section 

101.82 (21 CFR 101.82) of our 

regulations authorizes a health claim for 

food labels about soy protein and the 

risk of coronary heart disease. 

Accordingly, FDA established the 

previously referenced information 

collection in support of the regulation. 

In the Federal Register of October 31, 

2017 (82 FR 50324), we published a 

proposed rule to revoke the underlying 

regulation found at § 101.82. We are 

taking this action based on our review 

of the totality of publicly available 

scientific evidence currently available 

and our tentative conclusion that such 

evidence does not support our previous 

determination that there is significant 

scientific agreement among qualified 

experts for a health claim regarding the 

relationship between soy protein and 

reduced risk of coronary heart disease. 

Upon finalization of the proposed rule, 

the associated information collection 

requirements under this OMB control 

number will be revoked. Until such time 

and in accordance with the PRA, we 

retain our currently approved burden 

estimate for the information collection 

displayed in table 1 of this notice. 

In the Federal Register of March 8, 

2018 (83 FR 9856), FDA published a 60- 

day notice requesting public comment 

on the proposed collection of 

information. No comments were 

received. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1

21 CFR section Number of 

recordkeepers 

Number of 

records per 

recordkeeper 

Total 

annual 

records 

Average 

burden per 

recordkeeping 

Total 

hours 

101.82(c)(2)(ii)(B) ................................................................. 25 1 25 1 25 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 

Based on our current experience with 

the use of health claims, we estimate 25 

firms market products bearing a soy 

protein/coronary heart disease health 

claim and that perhaps one of each 

firm’s products might contain non-soy 

sources of protein along with soy 

protein. The records currently required 

to be retained under § 101.82(c)(2)(ii)(B) 

are the records, e.g., the formulation or 

recipe, that a manufacturer has and 

maintains as a normal course of its 

doing business. Thus, the burden to the 

food manufacturer is limited to 

assembling and retaining the records, 

which we estimate will take 1 hour 

annually. 

Dated: May 30, 2018. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2018–12216 Filed 6–6–18; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2012–N–0961] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Environmental 

Impact Considerations 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

announcing an opportunity for public 


sradovich on DSK3GMQ082PROD with NOTICES