34596 Federal Register / Vol. 83, No. 140 / Friday, July 20, 2018 / Notices 

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: 

Virginia Recta, Center for Veterinary 

Medicine (HFV–160), Food and Drug 

Administration, 7500 Standish Pl., 

Rockville, MD 20855, 240–402–0840, 

virginia.recta@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: In the 

Federal Register of May 21, 2018, FDA 

published a notice announcing the 

availability of draft revised GFI #197 

entitled ‘‘Documenting Electronic Data 

Files and Statistical Analysis Programs’’ 

with a 60-day comment period. We 

requested comments about informing 

sponsors of recommendations for 

documenting electronic data files and 

statistical analyses submitted to CVM to 

support new animal drug applications. 

These recommendations are intended to 

reduce the number of revisions that may 

be required for CVM to effectively 

review data submissions and to simplify 

submission preparation by providing a 

recommended documentation 

framework. 

The Agency has received a request for 

a 90-day extension of the comment 

period. The request conveyed concern 

that the current 60-day comment period 

does not allow sufficient time to 

develop a comprehensive response. 

FDA has considered the request and 

is extending the comment period for the 

notice of availability for 90 days, until 

October 18, 2018. The Agency believes 

that a 90-day extension allows adequate 

time for interested persons to submit 

comments. 

Dated: July 16, 2018. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2018–15568 Filed 7–19–18; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2008–N–0500] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Requirements on 

Content and Format of Labeling for 

Human Prescription Drug and 

Biological Products 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

announcing an opportunity for public 

comment on the proposed collection of 

certain information by the Agency. 

Under the Paperwork Reduction Act of 

1995 (PRA), Federal Agencies are 

required to publish notice in the 

Federal Register concerning each 

proposed collection of information, 

including each proposed extension of an 

existing collection of information, and 

to allow 60 days for public comment in 

response to the notice. This notice 

solicits comments on the information 

collection provisions of FDA’s 

requirements on content and format of 

labeling for human prescription drug 

and biological products. 

DATES: Submit either electronic or 

written comments on the collection of 

information by September 18, 2018. 

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 September 18, 

2018. The https://www.regulations.gov 

electronic filing system will accept 

comments until midnight Eastern Time 

at the end of September 18, 2018. 

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– 

2008–N–0500 for ‘‘Agency Information 

Collection Activities; Proposed 

Collection; Comment Request; 

Requirements on Content and Format of 

Labeling for Human Prescription Drug 

and Biological Products.’’ 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 


daltland on DSKBBV9HB2PROD with NOTICES
Federal Register / Vol. 83, No. 140 / Friday, July 20, 2018 / Notices 34597 

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: Ila 

S. Mizrachi, Office of Operations, Food 

and Drug Administration, Three White 

Flint North, 10A–12M, 11601 

Landsdown St., North Bethesda, MD 

20852, 301–796–7726, PRAStaff@

fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: Under the 

PRA (44 U.S.C. 3501–3520), Federal 

Agencies must obtain approval from the 

Office of Management and Budget 

(OMB) for each collection of 

information they conduct or sponsor. 

‘‘Collection of information’’ is defined 

in 44 U.S.C. 3502(3) and 5 CFR 

1320.3(c) and includes Agency requests 

or requirements that members of the 

public submit reports, keep records, or 

provide information to a third party. 

Section 3506(c)(2)(A) of the PRA (44 

U.S.C. 3506(c)(2)(A)) requires Federal 

Agencies to provide a 60-day notice in 

the Federal Register concerning each 

proposed collection of information, 

including each proposed extension of an 

existing collection of information, 

before submitting the collection to OMB 

for approval. To comply with this 

requirement, FDA is publishing notice 

of the proposed collection of 

information set forth in this document. 

With respect to the following 

collection of information, FDA invites 

comments on these topics: (1) Whether 

the proposed collection of information 

is necessary for the proper performance 

of FDA’s functions, including whether 

the information will have practical 

utility; (2) the accuracy of FDA’s 

estimate of the burden of the proposed 

collection of information, including the 

validity of the methodology and 

assumptions used; (3) ways to enhance 

the quality, utility, and clarity of the 

information to be collected; and (4) 

ways to minimize the burden of the 

collection of information on 

respondents, including through the use 

of automated collection techniques, 

when appropriate, and other forms of 

information technology. 

Requirements on Content and Format of 

Labeling for Human Prescription Drug 

and Biological Products 

OMB Control Number 0910–0572— 

Extension 

FDA’s regulations governing the 

content and format of labeling for 

human prescription drug and biological 

products were revised in the Federal 

Register of January 24, 2006 (71 FR 

3922) (the 2006 labeling rule) to require 

that the labeling of new and recently 

approved products contain highlights of 

prescribing information, a table of 

contents for prescribing information, 

reordering of certain sections, minor 

content changes, and minimum 

graphical requirements. These revisions 

were intended to make it easier for 

health care practitioners to access, read, 

and use information in prescription 

drug labeling; to enhance the safe and 

effective use of prescription drug 

products; and to reduce the number of 

adverse reactions resulting from 

medication errors because of 

misunderstood or incorrectly applied 

drug information. 

Currently, § 201.56 (21 CFR 201.56) 

requires that prescription drug labeling 

contain certain information in the 

format specified in either § 201.57 (21 

CFR 201.57) or § 201.80 (21 CFR 

201.80), depending on when the drug 

was approved for marketing. Section 

201.56(a) sets forth general labeling 

requirements applicable to all 

prescription drugs. Section 201.56(b) 

specifies the categories of new and more 

recently approved prescription drugs 

subject to the revised content and 

format requirements in §§ 201.56(d) and 

201.57. Section 201.56(c) sets forth the 

schedule for implementing these revised 

content and format requirements. 

Section 201.56(e) specifies the sections 

and subsections, required and optional, 

for the labeling of older prescription 

drugs not subject to the revised format 

and content requirements. 

Section 201.57(a) requires that 

prescription drug labeling for new and 

more recently approved prescription 

drug products include a ‘‘Highlights of 

Prescribing Information’’ section. The 

‘‘Highlights’’ section provides a concise 

extract of the most important 

information required under § 201.57(c) 

(the Full Prescribing Information (FPI)), 

as well as certain additional information 

important to prescribers. Section 

201.57(b) requires a table of contents to 

prescribing information entitled ‘‘Full 

Prescribing Information: Contents,’’ 

consisting of a list of each heading and 

subheading along with its identifying 

number to facilitate health care 

practitioners’ use of labeling 

information. Section 201.57(c) specifies 

the contents of the FPI. Section 

201.57(d) mandates the minimum 

specifications for the format of 

prescription drug labeling and 

establishes minimum requirements for 

key graphic elements such as bold type, 

bullet points, type size, and spacing. 

Older drugs not subject to the revised 

labeling content and format 

requirements in § 201.57 are subject to 

labeling requirements at § 201.80. 

Section 201.80(f)(2) requires that, within 

1 year, any FDA-approved patient 

labeling be referenced in the 

‘‘Precautions’’ section of the labeling of 

older products and either accompany or 

be reprinted immediately following the 

labeling. 

Annual Burden for Prescription Drug 

Labeling Design, Testing, and 

Submitting to FDA for New Drug 

Applications (NDAs) and Biologics 

License Applications (BLAs) 

(§§ 201.56 and 201.57) 

New drug product applicants must: 

(1) Design and create prescription drug 

labeling containing ‘‘Highlights,’’ 

‘‘Contents,’’ and FPI; (2) test the 

designed labeling (e.g., to ensure that 

the designed labeling fits into cartonenclosed products); and (3) submit it to 

FDA for approval. Based on the 

projected data used in the January 24, 

2006, final rule, FDA estimates that it 

will take applicants approximately 

2,327 hours to design, test, and submit 

prescription drug labeling to FDA as 

part of a NDA or a BLA under the 

revised regulations. Currently, 

approximately 406 applicants submit 

approximately 541 new applications 

(NDAs and BLAs) to FDA annually, 

totaling 1,258,907 hours. 

FDA estimates the burden of this 

collection of information as follows: 


daltland on DSKBBV9HB2PROD with NOTICES
34598 Federal Register / Vol. 83, No. 140 / Friday, July 20, 2018 / Notices 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

21 CFR part and activity Number of 

respondents 

Number of 

responses per 

respondent 2

Total annual 

responses 

Average 

burden 

per response 

Total hours 

Labeling Requirements in §§ 201.56 and 201.57 ................ 406 1.332 541 2,327 1,258,907 

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

2Estimates may not sum due to rounding. 

Our estimated burden for the 

information collection reflects an 

overall increase of 602,503 hours and a 

corresponding increase of 345 records. 

We attribute this adjustment to an 

increase in the number of submissions 

we received over the last few years. 

Dated: July 16, 2018. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2018–15512 Filed 7–19–18; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2018–D–1098] 

Metered Dose Inhaler and Dry Powder 

Inhaler Drug Products—Quality 

Considerations; Draft Guidance for 

Industry; Reopening of the Comment 

Period 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice; reopening of the 

comment period. 

SUMMARY: The Food and Drug 

Administration (FDA, Agency, or we) is 

reopening the comment period for the 

‘‘Metered Dose Inhaler and Dry Powder 

Inhaler Drug Products—Quality 

Considerations; Draft Guidance for 

Industry,’’ published in the Federal 

Register of April 19, 2018. FDA is 

reopening the comment period to allow 

interested persons additional time to 

submit comments. 

DATES: FDA is reopening the comment 

period on the notice published April 19, 

2018 (83 FR 17420). Submit either 

electronic or written comments by 

September 18, 2018. 

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 September 18, 

2018. The https://www.regulations.gov 

electronic filing system will accept 

comments until midnight Eastern Time 

at the end of September 18, 2018. 

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– 

2018–D–1098 for ‘‘Metered Dose Inhaler 

and Dry Powder Inhaler Drug 

Products—Quality Considerations; Draft 

Guidance for Industry.’’ 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 

‘‘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 the 

Division of Drug Information, Center for 


daltland on DSKBBV9HB2PROD with NOTICES