Federal Register / Vol. 82, No. 202 / Friday, October 20, 2017 / Notices 48827 

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 guidances 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access to the draft guidance documents. 

FOR FURTHER INFORMATION CONTACT: 

Xiaoqiu Tang, Center for Drug 

Evaluation and Research (HFD–600), 

Food and Drug Administration, 10903 

New Hampshire Ave., Bldg. 75, Rm. 

4730, Silver Spring, MD 20993–0002, 

301–796–5850. 

SUPPLEMENTARY INFORMATION: 

I. Background 

In the Federal Register of June 11, 

2010 (75 FR 33311), FDA announced the 

availability of a guidance for industry 

entitled ‘‘Bioequivalence 

Recommendations for Specific 

Products’’ that explained the process 

that would be used to make productspecific guidances available to the 

public on FDA’s Web site at https://

www.fda.gov/Drugs/Guidance

ComplianceRegulatoryInformation/

Guidances/default.htm. 

As described in that guidance, FDA 

adopted this process as a means to 

develop and disseminate productspecific guidances and provide a 

meaningful opportunity for the public to 

consider and comment on those 

guidances. Under that process, draft 

guidances are posted on FDA’s Web site 

and announced periodically in the 

Federal Register. The public is 

encouraged to submit comments on 

those recommendations within 60 days 

of their announcement in the Federal 

Register. FDA considers any comments 

received and either publishes final 

guidances or publishes revised draft 

guidances for comment. Guidances were 

last announced in the Federal Register 

on July 14, 2017 (82 FR 32556). This 

notice announces draft product-specific 

guidances, either new or revised, that 

are posted on FDA’s Web site. 

II. Drug Products for Which New Draft 

Product-Specific Guidances Are 

Available 

FDA is announcing the availability of 

new draft product-specific guidances for 

industry for drug products containing 

the following active ingredients: 

TABLE 1—NEW DRAFT PRODUCT-SPECIFIC GUIDANCES FOR DRUG PRODUCTS

Azelastine hydrochloride. 

Azithromycin. 

Barium sulfate. 

Betamethasone dipropionate. 

Budesonide. 

Canagliflozin; Metformin hydrochloride. 

Dantrolene sodium. 

Dapsone. 

Deflazacort (multiple Reference Listed 

Drugs). 

Docosanol. 

Empagliflozin; Metformin hydrochloride. 

Epinephrine. 

Erythromycin. 

Everolimus. 

Fluorometholone. 

Hydrocortisone acetate. 

Ivermectin. 

Levorphanol tartrate. 

Lisdexamfetamine dimesylate. 

Mometasone furoate. 

Nitisinone. 

Olaparib. 

Osimertinib mesylate. 

Permethrin. 

Pirfenidone. 

Telotristat etiprate. 

Terbutaline sulfate. 

III. Drug Products for Which Revised 

Draft Product-Specific Guidances Are 

Available 

FDA is announcing the availability of 

revised draft product-specific guidances 

for industry for drug products 

containing the following active 

ingredients: 

TABLE 2—REVISED DRAFT PRODUCTSPECIFIC GUIDANCES FOR DRUG

PRODUCTS

Brimonidine tartrate (multiple Reference Listed Drugs). 

Bromfenac sodium. 

Ciprofloxacin hydrochloride. 

Cobicistat; Elvitegravir; Emtricitabine; 

Tenofovir alafenamide fumarate. 

Dapsone. 

Diclofenac sodium. 

Emtricitabine; Rilpivirine hydrochloride; 

Tenofovir alafenamide fumarate. 

Emtricitabine; Tenofovir alafenamide fumarate. 

Esomeprazole magnesium. 

TABLE 2—REVISED DRAFT PRODUCTSPECIFIC GUIDANCES FOR DRUG

PRODUCTS—Continued 

Lisdexamfetamine dimesylate. 

Mesalamine. 

Mycophenolate mofetil. 

Ofloxacin. 

Olopatadine hydrochloride (multiple Reference Listed Drugs). 

Ropinirole hydrochloride. 

Sucralfate. 

Tadalafil. 

For a complete history of previously 

published Federal Register notices 

related to product-specific guidances, go 

to https://www.regulations.gov and 

enter Docket No. FDA–2007–D–0369. 

These draft guidances are being 

issued consistent with FDA’s good 

guidance practices regulation (21 CFR 

10.115). These draft guidances, when 

finalized, will represent the current 

thinking of FDA on, among other things, 

the product-specific design of BE 

studies to support ANDAs. They do not 

establish any rights for any person and 

are 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. 

IV. Electronic Access 

Persons with access to the internet 

may obtain the draft guidances at either 

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

ComplianceRegulatoryInformation/

Guidances/default.htm or https://

www.regulations.gov. 

Dated: October 16, 2017. 

Anna K. Abram, 

Deputy Commissioner for Policy, Planning, 

Legislation, and Analysis. 

[FR Doc. 2017–22736 Filed 10–19–17; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2015–N–1349] 

Extension of the Timetable 

Requirement To Submit Study Data in 

Logical Observation Identifiers Names 

and Codes 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA or the Agency) is 

announcing the extension of the 

deadline to provide Logical Observation 

Identifiers Names and Codes (LOINC) 


srobinson on DSKBC5CHB2PROD with NOTICES
48828 Federal Register / Vol. 82, No. 202 / Friday, October 20, 2017 / Notices 

for clinical laboratory test results in 

investigational study data provided in 

regulatory submissions submitted to the 

Center for Drug Evaluation and Research 

and to the Center for Biologics 

Evaluation and Research. FDA has 

determined, in response to industry 

comments and internal review, that it is 

appropriate to extend the date required 

to submit LOINC codes in new drug 

applications (NDAs), abbreviated new 

drug applications (ANDAs), and 

biologics license applications (BLAs), 

and for certain investigational new 

drugs (INDs). LOINC codes will be 

required in NDAs, ANDAs, and BLAs 

for studies that start after March 15, 

2020 (March 15, 2021, for certain INDs). 

ADDRESSES: You may submit either 

electronic or written comments 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– 

2015–N–1349 for ‘‘Extension of the 

Timetable Requirement to Submit Study 

Data in Logical Observation Identifiers 

Names and Codes.’’ 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. 

FOR FURTHER INFORMATION CONTACT: Ron 

Fitzmartin, Center for Drug Evaluation 

and Research, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 51, Rm. 1115, Silver Spring, 

MD 20993–0002, 301–796–5333, 

cderdatastandards@fda.hhs.gov; or 

Stephen Ripley, Center for Biologics 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 71, Rm. 7268, 

Silver Spring, MD 20993–0002, 240– 

402–7911, stephen.ripley@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: On May 

14, 2015, FDA announced in the 

Federal Register (80 FR 27690) its 

adoption of LOINC for lab test results. 

FDA supports LOINC-coded laboratory 

test results because: (1) LOINC is widely 

used among clinical laboratories; (2) 

LOINC-coded lab data make the 

information easier to understand and 

analyze; and (3) the currently supported 

exchange standard for laboratory test 

results in clinical trials, the Study Data 

Tabulation Model (available at http://

www.cdisc.org/sdtm), already supports 

the exchange of LOINC codes (available 

at https://loinc.org/). FDA’s decision to 

adopt LOINC for lab test results is part 

of a larger FDA effort to align the use of 

data standards for clinical research with 

ongoing nationwide health information 

technology initiatives. The FDA Data 

Standards Catalog was updated to 

indicate FDA support for LOINC and a 

requirement date of March 15, 2018, for 

NDAs, ANDAs, and BLAs, and March 

15, 2019, for certain INDs (see https:// 

www.fda.gov/forindustry/ 

datastandards/studydatastandards/ 

default.htm). FDA has determined, in 

response to industry comments and 

internal review, that it is appropriate to 

extend the date required to submit 

LOINC codes. LOINC codes will be 

required in NDAs, ANDAs, and BLAs 

for studies that start after March 15, 

2020 (March 15, 2021, for certain INDs). 

Although use of LOINC codes are not 

required at this time, FDA continues to 

support and encourages the use of 

LOINC codes for clinical laboratory test 

results used in investigational study 

data. 

Dated: October 16, 2017. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2017–22768 Filed 10–19–17; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2017–D–6133] 

Application of the ‘‘Solely Engaged’’ 

Exemptions in Parts 117 and 507; Draft 

Guidance for Industry; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notification of availability. 


srobinson on DSKBC5CHB2PROD with NOTICES