65690 Federal Register / Vol. 83, No. 245 / Friday, December 21, 2018 / Notices 

I. Background 

FDA is announcing the availability of 

a document entitled ‘‘Labeling of Red 

Blood Cell Units with Historical 

Antigen Typing Results; Guidance for 

Industry.’’ The guidance document 

provides establishments that collect 

blood and blood components for 

transfusion with recommendations for 

labeling RBC units with historical 

antigen typing results. The guidance 

provides recommendations to 

transfusion services for managing RBC 

units labeled with historical antigen 

typing results. This guidance also 

provides licensed blood establishments 

that choose to implement labeling of 

RBC units with historical antigen typing 

results instructions regarding how to 

report the manufacturing and labeling 

changes under 21 CFR 601.12. The 

guidance does not apply to test results 

for ABO and Rh(D) antigens. For ABO 

and Rh(D) antigens, establishments 

must follow FDA requirements in 21 

CFR 640.5(b) and (c), and 606.121(c)(9) 

and (13), as well as all other applicable 

requirements. 

FDA’s Blood Products Advisory 

Committee discussed this topic on 

December 4, 2012, and supported the 

concept of using historical RBC antigen 

typing results to label RBC units. AABB 

has revised its standards to include 

accommodations for labeling RBC units 

with historical RBC typing results. 

According to the 30th edition of the 

AABB Standards for Blood Banks and 

Transfusion Services, RBC units may be 

labeled as RBC antigen negative without 

testing the current donation if two 

previous separate donations were tested 

by the collection facility and results of 

RBC typing were found to be 

concordant. The standards indicate that 

facilities have the option to put the nonABO/Rh(D) historical antigen typing 

results on a tie-tag or directly on the 

container label. 

In the Federal Register of January 3, 

2017 (82 FR 130), FDA announced the 

availability of the draft guidance of the 

same title dated January 2017. FDA 

received several comments on the draft 

guidance and those comments were 

considered as the guidance was 

finalized. In addition, editorial changes 

were made to improve clarity. The 

guidance announced in this notice 

finalizes the draft guidance dated 

January 2017. 

This guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The guidance represents the current 

thinking of FDA on labeling of red blood 

cell units with historical antigen typing 

results. 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 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 guidance refers to the 

collections of information for putting 

the non-ABO/Rh(D) historical antigen 

typing results on a tie-tag or directly on 

the container label. These collections of 

information have been approved under 

OMB control number 0910–0862. The 

guidance also refers to previously 

approved collections of information 

found in FDA regulations. The 

collections of information in 21 CFR 

part 601 and Form FDA 356h have been 

approved under OMB control number 

0910–0338; and the collections of 

information in 21 CFR part 606 have 

been approved under OMB control 

number 0910-0116. 

III. Electronic Access 

Persons with access to the internet 

may obtain the guidance at either 

https://www.fda.gov/BiologicsBlood

Vaccines/Guidance

ComplianceRegulatoryInformation/ 

Guidances/default.htm or https://

www.regulations.gov. 

Dated: December 18, 2018. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2018–27654 Filed 12–20–18; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2018–D–4455] 

Developing and Submitting Proposed 

Draft Guidance Relating to Patient 

Experience Data; Draft Guidance for 

Industry and Other Stakeholders; 

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 

‘‘Developing and Submitting Proposed 

Draft Guidance Relating to Patient 

Experience Data.’’ This draft guidance is 

being developed under the 21st Century 

Cures Act (Cures Act), which directs 

FDA to issue guidance on how a person 

seeking to develop and submit a 

proposed draft guidance relating to 

patient experience data for 

consideration by FDA may submit such 

proposed draft guidance to the Agency. 

DATES: Submit either electronic or 

written comments on the draft guidance 

by March 21, 2019 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 

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–4455 for ‘‘Developing and 

Submitting Proposed Draft Guidance 


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Federal Register / Vol. 83, No. 245 / Friday, December 21, 2018 / Notices 65691 

Relating to Patient Experience Data.’’ 

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; or the Office of Communication, 

Outreach and Development, Center for 

Biologics Evaluation and Research 

(CBER), Food and Drug Administration, 

10903 New Hampshire Ave., Bldg. 71, 

Rm. 3128, Silver Spring, MD 20993– 

0002. Send one self-addressed adhesive 

label to assist that office in processing 

your requests. The draft guidance may 

also be obtained by mail by calling 

CBER at 1–800–835–4709 or 240–402– 

8010. See the SUPPLEMENTARY

INFORMATION section for electronic 

access to the guidance document. 

FOR FURTHER INFORMATION CONTACT: 

Pujita Vaidya, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 51, Rm. 1144, 

Silver Spring, MD 20993–0002, 301– 

796–0684, Fax: 301–847–8443, 

pujita.vaidya@fda.hhs.gov; or Stephen 

Ripley, Center for Biologics Evaluation 

and Research, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 71, Rm. 7301, Silver Spring, 

MD 20993–0002, 240–402–7911. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a draft guidance for industry and other 

stakeholders entitled ‘‘Developing and 

Submitting Proposed Draft Guidance 

Relating to Patient Experience Data.’’ 

This draft guidance in being developed 

under section 3002(c)(5) of the Cures 

Act, which directs FDA to issue 

guidance on how a person seeking to 

develop and submit a proposed draft 

guidance relating to patient experience 

data for consideration by FDA may 

submit such proposed draft guidance to 

the Agency (see the Cures Act, https:// 

www.congress.gov/114/plaws/publ255/

PLAW-114publ255.pdf 

Patient experience data should be 

collected and analyzed in a 

methodologically sound and fit-forpurpose manner. There are several 

options for contributing patient 

experience data to the medical product 

development and regulatory decisionmaking process. One option is for 

stakeholders to submit proposed 

recommendations and considerations 

informed by patient experience data in 

the form of a proposed draft guidance. 

Proposed draft guidance relating to 

patient experience data that is 

developed and submitted by external 

stakeholders can be helpful in bringing 

the patient’s perspective into medical 

product development and regulatory 

decision-making. 

As stated previously, submitting 

proposed draft guidance for FDA’s 

consideration is not the only option for 

contributing patient experience data. 

Patients, caregivers, patient and disease 

advocacy groups, and other stakeholders 

with knowledge of or access to the 

patient community, may be wellpositioned to also make broader 

contributions to advance medical 

product development. Recognizing that 

stakeholders may be interested in 

pursuing other pathways to contribute 

patient experience data, this draft 

guidance addresses questions relating to 

both guidance development and other 

potential pathways for contributing 

patient experience data. 

In FDA’s ‘‘Plan for Issuance of 

Patient-Focused Drug Development 

Guidance’’ (Plan), available at https://

www.fda.gov/downloads/ForIndustry/

UserFees/PrescriptionDrugUserFee/

UCM563618.pdf, the Agency proposed 

issuing a draft guidance addressing this 

topic described in section 3002 of the 

Cures Act during the second quarter of 

2018. FDA recognized that, like the 

other patient-focused drug development 

guidances described in the Plan, 

developing this draft guidance would 

also benefit from public input from the 

wider community of patients, patient 

advocates, academic researchers, expert 

practitioners, drug developers, and 

other stakeholders before FDA’s drafting 

of the guidance. On March 19, 2018, 

FDA conducted a public workshop to 

discuss this topic. After the public 

workshop, FDA considered stakeholder 

input from the workshop and the public 

docket and is now publishing this draft 

guidance. 

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 ‘‘Developing and Submitting 

Proposed Draft Guidance Relating to 

Patient Experience Data.’’ 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. Electronic Access 

Persons with access to the internet 

may obtain the draft guidance at https:// 

www.fda.gov/Drugs/Guidance

ComplianceRegulatoryInformation/

Guidances/default.htm, https://

www.fda.gov/BiologicsBloodVaccines/

GuidanceComplianceRegulatory

Information/Guidances/default.htm, or 

https://www.regulations.gov. 

Dated: December 18, 2018. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2018–27657 Filed 12–20–18; 8:45 am] 

BILLING CODE 4164–01–P 


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