Federal Register / Vol. 80, No. 37 / Wednesday, February 25, 2015 / Notices 10117 

the Executive Order and subject to 

review by the Office of Management and 

Budget (OMB). Section 3(f) of Executive 

Order 12866 defines a ‘‘significant 

regulatory action’’ as an action likely to 

result in a rule that may— 

(1) Have an annual effect on the 

economy of $100 million or more, or 

adversely affect a sector of the economy, 

productivity, competition, jobs, the 

environment, public health or safety, or 

State, local, or tribal governments or 

communities in a material way (also 

referred to as an ‘‘economically 

significant’’ rule); 

(2) Create serious inconsistency or 

otherwise interfere with an action taken 

or planned by another agency; 

(3) Materially alter the budgetary 

impacts of entitlement grants, user fees, 

or loan programs or the rights and 

obligations of recipients thereof; or 

(4) Raise novel legal or policy issues 

arising out of legal mandates, the 

President’s priorities, or the principles 

stated in the Executive Order. 

This proposed regulatory action is not 

a significant regulatory action subject to 

review by OMB under section 3(f) of 

Executive Order 12866. 

We have also reviewed this regulatory 

action under Executive Order 13563, 

which supplements and explicitly 

reaffirms the principles, structures, and 

definitions governing regulatory review 

established in Executive Order 12866. 

To the extent permitted by law, 

Executive Order 13563 requires that an 

agency— 

(1) Propose or adopt regulations only 

upon a reasoned determination that 

their benefits justify their costs 

(recognizing that some benefits and 

costs are difficult to quantify); 

(2) Tailor its regulations to impose the 

least burden on society, consistent with 

obtaining regulatory objectives and 

taking into account—among other things 

and to the extent practicable—the costs 

of cumulative regulations; 

(3) In choosing among alternative 

regulatory approaches, select those 

approaches that maximize net benefits 

(including potential economic, 

environmental, public health and safety, 

and other advantages; distributive 

impacts; and equity); 

(4) To the extent feasible, specify 

performance objectives, rather than the 

behavior or manner of compliance a 

regulated entity must adopt; and 

(5) Identify and assess available 

alternatives to direct regulation, 

including economic incentives—such as 

user fees or marketable permits—to 

encourage the desired behavior, or 

provide information that enables the 

public to make choices. 

Executive Order 13563 also requires 

an agency ‘‘to use the best available 

techniques to quantify anticipated 

present and future benefits and costs as 

accurately as possible.’’ The Office of 

Information and Regulatory Affairs of 

OMB has emphasized that these 

techniques may include ‘‘identifying 

changing future compliance costs that 

might result from technological 

innovation or anticipated behavioral 

changes.’’ 

We are issuing this proposed priority 

only upon a reasoned determination 

that its benefits would justify its costs. 

In choosing among alternative 

regulatory approaches, we selected 

those approaches that would maximize 

net benefits. Based on the analysis that 

follows, the Department believes that 

this proposed priority is consistent with 

the principles in Executive Order 13563. 

We also have determined that this 

regulatory action would not unduly 

interfere with State, local, and tribal 

governments in the exercise of their 

governmental functions. 

In accordance with both Executive 

Orders, the Department has assessed the 

potential costs and benefits, both 

quantitative and qualitative, of this 

regulatory action. The potential costs 

are those resulting from statutory 

requirements and those we have 

determined as necessary for 

administering the Department’s 

programs and activities. 

The benefits of the Disability and 

Rehabilitation Research Projects and 

Centers Program have been well 

established over the years. Projects 

similar to one envisioned by the 

proposed priority have been completed 

successfully, and the proposed priority 

would generate new knowledge through 

research. The new DRRP would 

generate, disseminate, and promote the 

use of new information that would 

improve accessibility of the built 

environment for individuals with 

disabilities. 

Intergovernmental Review: This 

program is not subject to Executive 

Order 12372. 

Electronic Access to This Document: 

The official version of this document is 

the document published in the Federal 

Register. Free Internet access to the 

official edition of the Federal Register 

and the Code of Federal Regulations is 

available via the Federal Digital System 

at: www.gpo.gov/fdsys. At this site you 

can view this document, as well as all 

other documents of this Department 

published in the Federal Register, in 

text or Adobe Portable Document 

Format (PDF). To use PDF you must 

have Adobe Acrobat Reader, which is 

available free at the site. 

You may also access documents of the 

Department published in the Federal 

Register by using the article search 

feature at: www.federalregister.gov. 

Specifically, through the advanced 

search feature at this site, you can limit 

your search to documents published by 

the Department. 

Dated: February 19, 2015. 

Kathy Greenlee, 

Administrator. 

[FR Doc. 2015–03888 Filed 2–24–15; 8:45 am] 

BILLING CODE 4154–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2011–N–0362] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Current Good 

Manufacturing Practice Regulations for 

Finished Pharmaceuticals 

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. 

DATES: Fax written comments on the 

collection of information by March 27, 

2015. 

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 0910–0139. Also 

include the FDA docket number found 

in brackets in the heading of this 

document. 

FOR FURTHER INFORMATION CONTACT: FDA 

PRA Staff, Office of Operations, Food 

and Drug Administration, 8455 

Colesville Rd., COLE–14526, Silver 

Spring, MD 20993–0002, 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. 


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10118 Federal Register / Vol. 80, No. 37 / Wednesday, February 25, 2015 / Notices 

Current Good Manufacturing Practice 

Regulations for Finished 

Pharmaceuticals—21 CFR Parts 210 

and 211 (OMB Control Number 0910– 

0139) 

Under section 501(a)(2)(B) of the 

Federal Food, Drug, and Cosmetic Act 

(the FD&C Act) (21 U.S.C. 351(a)(2)(B)), 

a drug is adulterated if the methods 

used in, or the facilities or controls used 

for, its manufacture, processing, 

packing, or holding do not conform to 

or are not operated or administered in 

conformity with current good 

manufacturing practices (CGMPs) to 

ensure that such drug meets the 

requirements of the FD&C Act as to 

safety, and has the identity and strength, 

and meets the quality and purity 

characteristics, which it purports or is 

represented to possess. 

The FDA has the authority under 

section 701(a) of the FD&C Act (21 

U.S.C. 371(a)) to issue regulations for 

the efficient enforcement of the FD&C 

Act regarding CGMP procedures for 

manufacturing, processing, and holding 

drugs and drug products. The CGMP 

regulations help ensure that drug 

products meet the statutory 

requirements for safety and have their 

purported or represented identity, 

strength, quality, and purity 

characteristics. The information 

collection requirements in the CGMP 

regulations provide FDA with the 

necessary information to perform its 

duty to protect public health and safety. 

CGMP requirements establish 

accountability in the manufacturing and 

processing of drug products, provide for 

meaningful FDA inspections, and 

enable manufacturers to improve the 

quality of drug products over time. The 

CGMP recordkeeping requirements also 

serve preventive and remedial purposes 

and provide crucial information if it is 

necessary to recall a drug product. 

The general requirements for 

recordkeeping under part 211 (21 CFR 

part 211) are set forth in § 211.180. Any 

production, control, or distribution 

record associated with a batch and 

required to be maintained in 

compliance with part 211 must be 

retained for at least 1 year after the 

expiration date of the batch and, for 

certain over-the-counter (OTC) drugs, 3 

years after distribution of the batch 

(§ 211.180(a)). Records for all 

components, drug product containers, 

closures, and labeling are required to be 

maintained for at least 1 year after the 

expiration date and 3 years for certain 

OTC products (§ 211.180(b)). 

All part 211 records must be readily 

available for authorized inspections 

during the retention period 

(§ 211.180(c)), and such records may be 

retained either as original records or as 

true copies (§ 211.180(d)). In addition, 

21 CFR 11.2(a) provides that for records 

required to be maintained but not 

submitted to the Agency, persons may 

use electronic records in lieu of paper 

records or electronic signatures in lieu 

of traditional signatures, in whole or in 

part, provided that the requirements of 

this part are met. To the extent this 

electronic option is used, the burden of 

maintaining paper records should be 

substantially reduced, as should any 

review of such records. 

In order to facilitate improvements 

and corrective actions, records must be 

maintained so that data can be used for 

evaluating, at least annually, the quality 

standards of each drug product to 

determine the need for changes in drug 

product specifications or manufacturing 

or control procedures (§ 211.180(e)). 

Written procedures for these evaluations 

are to be established and include 

provisions for a review of a 

representative number of batches and, 

where applicable, records associated 

with the batch; provisions for a review 

of complaints, recalls, returned, or 

salvaged drug products; and 

investigations conducted under 

§ 211.192 for each drug product. 

The specific recordkeeping 

requirements provided in table 1 are as 

follows: 

Section 211.34—Consultants advising 

on the manufacture, processing, 

packing, or holding of drug products 

must have sufficient education, training, 

and experience to advise on the subject 

for which they are retained. Records 

must be maintained stating the name, 

address, and qualifications of any 

consultants and the type of service they 

provide. 

Section 211.67(c)—Records must be 

kept of maintenance, cleaning, 

sanitizing, and inspection as specified 

in §§ 211.180 and 211.182. 

Section 211.68—Appropriate controls 

must be exercised over computer or 

related systems to assure that changes in 

master production and control records 

or other records are instituted only by 

authorized personnel. 

Section 211.68(a)—Records must be 

maintained of calibration checks, 

inspections, and computer or related 

system programs for automatic, 

mechanical, and electronic equipment. 

Section 211.68(b)—All appropriate 

controls must be exercised over all 

computers or related systems and 

control data systems to assure that 

changes in master production and 

control records or other records are 

instituted only by authorized persons. 

Section 211.72—Filters for liquid 

filtration used in the manufacture, 

processing, or packing of injectable drug 

products intended for human use must 

not release fibers into such products. 

Section 211.80(d)—Each container or 

grouping of containers for components 

or drug product containers or closures 

must be identified with a distinctive 

code for each lot in each shipment 

received. This code must be used in 

recording the disposition of each lot. 

Each lot must be appropriately 

identified as to its status. 

Section 211.100(b)—Written 

production and process control 

procedures must be followed in the 

execution of the various production and 

process control functions and must be 

documented at the time of performance. 

Any deviation from the written 

procedures must be recorded and 

justified. 

Section 211.105(b)—Major equipment 

must be identified by a distinctive 

identification number or code that must 

be recorded in the batch production 

record to show the specific equipment 

used in the manufacture of each batch 

of a drug product. In cases where only 

one of a particular type of equipment 

exists in a manufacturing facility, the 

name of the equipment may be used in 

lieu of a distinctive identification 

number or code. 

Section 211.122(c)—Records must be 

maintained for each shipment received 

of each different labeling and packaging 

material indicating receipt, 

examination, or testing. 

Section 211.130(e)—Inspection of 

packaging and labeling facilities must be 

made immediately before use to assure 

that all drug products have been 

removed from previous operations. 

Inspection must also be made to assure 

that packaging and labeling materials 

not suitable for subsequent operations 

have been removed. Results of 

inspection must be documented in the 

batch production records. 

Section 211.132(c)—Certain retail 

packages of OTC drug products must 

bear a statement that is prominently 

placed so consumers are alerted to the 

specific tamper-evident feature of the 

package. The labeling statement is 

required to be so placed that it will be 

unaffected if the tamper-resistant feature 

of the package is breached or missing. 

If the tamper-evident feature chosen is 

one that uses an identifying 

characteristic, that characteristic is 

required to be referred to in the labeling 

statement. 

Section 211.132(d)—A request for an 

exemption from packaging and labeling 

requirements by a manufacturer or 

packer is required to be submitted in the 


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form of a citizen petition under 21 CFR 

10.30. 

Section 211.137—Requirements 

regarding product expiration dating and 

compliance with 21 CFR 201.17. 

Section 211.160(a)—The 

establishment of any specifications, 

standards, sampling plans, test 

procedures, or other laboratory control 

mechanisms, including any change in 

such specifications, standards, sampling 

plans, test procedures, or other 

laboratory control mechanisms, must be 

drafted by the appropriate 

organizational unit and reviewed and 

approved by the quality control unit. 

These requirements must be followed 

and documented at the time of 

performance. Any deviation from the 

written specifications, standards, 

sampling plans, test procedures, or 

other laboratory control mechanisms 

must be recorded and justified. 

Section 211.165(e)—The accuracy, 

sensitivity, specificity, and 

reproducibility of test methods 

employed by a firm must be established 

and documented. Such validation and 

documentation may be accomplished in 

accordance with § 211.194(a)(2). 

Section 211.166—Stability testing 

program for drug products. 

Section 211.173—Animals used in 

testing components, in-process 

materials, or drug products for 

compliance with established 

specifications must be maintained and 

controlled in a manner that assures their 

suitability for their intended use. They 

must be identified, and adequate 

records must be maintained showing the 

history of their use. 

Section 211.180(e)—Written records 

required by part 211 must be 

maintained so that data can be used for 

evaluating, at least annually, the quality 

standards of each drug product to 

determine the need for changes in drug 

product specifications or manufacturing 

or control procedures. Written 

procedures must be established and 

followed for such evaluations and must 

include provisions for a representative 

number of batches, whether approved or 

unapproved or rejected, and a review of 

complaints, recalls, returned, or 

salvaged drug products, and 

investigations conducted under 

§ 211.192 for each drug product. 

Section 211.180(f)—Procedures must 

be established to assure that the 

responsible officials of the firm, if they 

are not personally involved in or 

immediately aware of such actions, are 

notified in writing of any investigations, 

conducted under § 211.198, 211.204, or 

211.208, any recalls, reports of 

inspectional observations issued, or any 

regulatory actions relating to good 

manufacturing practices brought by 

FDA. 

Section 211.182—Specifies 

requirements for equipment cleaning 

records and the use log. 

Section 211.184—Specifies 

requirements for component, drug 

product container, closure, and labeling 

records. 

Section 211.186—Specifies master 

production and control records 

requirements. 

Section 211.188—Specifies batch 

production and control records 

requirement. 

Section 211.192—Specifies the 

information that must be maintained on 

the investigation of discrepancies found 

in the review of all drug product 

production and control records by the 

quality control staff. 

Section 211.194—Explains and 

describes laboratory records that must 

be retained. 

Section 211.196—Specifies the 

information that must be included in 

records on the distribution of the drug. 

Section 211.198—Specifies and 

describes the handling of all complaint 

files received by the applicant. 

Section 211.204—Specifies that 

records be maintained of returned and 

salvaged drug products and describes 

the procedures involved. 

Written procedures, referred to here 

as standard operating procedures 

(SOPs), are required for many part 211 

records. The current SOP requirements 

were initially provided in a final rule 

published in the Federal Register of 

September 29, 1978 (43 FR 45014), and 

are now an integral and familiar part of 

the drug manufacturing process. The 

major information collection impact of 

SOPs results from their creation. 

Thereafter, SOPs need to be periodically 

updated. A combined estimate for 

routine maintenance of SOPs is 

provided in table 1. The 25 SOP 

provisions under part 211 in the 

combined maintenance estimate 

include: 

Section 211.22(d)—Responsibilities 

and procedures of the quality control 

unit; 

Section 211.56(b)—Sanitation 

procedures; 

Section 211.56(c)—Use of suitable 

rodenticides, insecticides, fungicides, 

fumigating agents, and cleaning and 

sanitizing agents; 

Section 211.67(b)—Cleaning and 

maintenance of equipment; 

Section 211.68(a)—Proper 

performance of automatic, mechanical, 

and electronic equipment; 

Section 211.80(a)—Receipt, 

identification, storage, handling, 

sampling, testing, and approval or 

rejection of components and drug 

product containers or closures; 

Section 211.94(d)—Standards or 

specifications, methods of testing, and 

methods of cleaning, sterilizing, and 

processing to remove pyrogenic 

properties for drug product containers 

and closures; 

Section 211.100(a)—Production and 

process control; 

Section 211.110(a)—Sampling and 

testing of in-process materials and drug 

products; 

Section 211.113(a)—Prevention of 

objectionable microorganisms in drug 

products not required to be sterile; 

Section 211.113(b)—Prevention of 

microbiological contamination of drug 

products purporting to be sterile, 

including validation of any sterilization 

process; 

Section 211.115(a)—System for 

reprocessing batches that do not 

conform to standards or specifications, 

to insure that reprocessed batches 

conform with all established standards, 

specifications, and characteristics; 

Section 211.122(a)—Receipt, 

identification, storage, handling, 

sampling, examination and/or testing of 

labeling and packaging materials; 

Section 211.125(f)—Control 

procedures for the issuance of labeling; 

Section 211.130—Packaging and label 

operations, prevention of mixup and 

cross contamination, identification and 

handling of filed drug product 

containers that are set aside and held in 

unlabeled condition, and identification 

of the drug product with a lot or control 

number that permits determination of 

the history of the manufacture and 

control of the batch; 

Section 211.142—Warehousing; 

Section 211.150—Distribution of drug 

products; 

Section 211.160—Laboratory controls; 

Section 211.165(c)—Testing and 

release for distribution; 

Section 211.166(a)—Stability testing; 

Section 211.167—Special testing 

requirements; 

Section 211.180(f)—Notification of 

responsible officials of investigations, 

recalls, reports of inspectional 

observations, and any regulatory actions 

relating to good manufacturing practice; 

Section 211.198(a)—Written and oral 

complaint procedures, including quality 

control unit review of any complaint 

involving specifications failures, and 

serious and unexpected adverse drug 

experiences; 

Section 211.204—Holding, testing, 

and reprocessing of returned drug 

products; and 

Section 211.208—Drug product 

salvaging. 

In addition, the following regulations 

in parts 610 and 680 (21 CFR parts 610 


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10120 Federal Register / Vol. 80, No. 37 / Wednesday, February 25, 2015 / Notices 

and 680) reference certain CGMP 

regulations in part 211: §§ 610.12(g), 

610.13(a)(2), 610.18(d), 680.2(f), and 

680.3(f). In table 1, the burden 

associated with the information 

collection requirements in these 

regulations is included in the burden 

estimates under §§ 211.165, 211.167, 

211.188, and 211.194, as appropriate. 

Although most of the CGMP 

provisions covered in this document 

were created many years ago, there will 

be some existing firms expanding into 

new manufacturing areas and startup 

firms that will need to create SOPs. As 

provided in table 1, FDA is assuming 

that approximately 100 firms will have 

to create up to 25 SOPs for a total of 

2,500 records, and the Agency estimates 

that it will take 20 hours per 

recordkeeper to create 25 new SOPs for 

a total of 50,000 hours. 

In the Federal Register of November 

10, 2014 (79 FR 66724), 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 

SOP Maintenance .................... 4,360 1 4,360 25 ............................................ 109,000 

New startup SOPs ................... 100 25 2500 20 ............................................ 50,000 

211.34—Consultants ................ 4,360 .25 1,090 .5 (30 minutes) ........................ 545 

211.67(c)—Equipment cleaning 

and maintenance.

4,360 50 218,000 .25 (15 minutes) ...................... 54,500 

211.68—Changes in master 

production and control 

records or other records.

4,360 2 8,720 1 .............................................. 8,720 

211.68(a)—Automatic, mechanical, and electronic 

equipment.

4,360 10 43,600 .5 (30 minutes) ........................ 21,800 

211.68(b)—Computer or related systems.4,360 5 21,800 .25 (15 minutes) ...................... 5,450 

211.72—Filters ......................... 4,360 .25 1,090 1 .............................................. 1,090 

211.80(d)—Components and 

drug product containers or 

closures.

4,360 .25 1,090 .10 (6 minutes) ........................ 109 

211.100(b)—Production and 

process controls.

4,360 3 13,080 2 .............................................. 26,160 

211.105(b)—Equipment identification.4,360 .25 1,090 .25 (15 minutes) ...................... 273 

211.122(c)—Labeling and 

packaging material.

4,360 50 218,000 .25 (15 minutes) ...................... 54,500 

211.130(e)—Labeling and 

packaging facilities.

4,360 50 218,000 .25 (15 minutes) ...................... 54,500 

211.132(c)—Tamper-evident 

packaging.

1,769 20 35,380 .5 (30 minutes) ........................ 17,690 

211.132(d)—Tamper-evident 

packaging.

1,769 .2 354 .5 (30 minutes) ........................ 177 

211.137—Expiration dating ...... 4,360 5 21,800 .5 (30 minutes) ........................ 10,900 

211.160(a)—Laboratory controls.4,360 2 8,720 1 .............................................. 8,720 

211.165(e)—Test methodology 4,360 1 4,360 1 .............................................. 4,360 

211.166—Stability testing ........ 4,360 2 8,720 .5 (30 minutes) ........................ 4,360 

211.173—Laboratory animals .. 1,077 1 1,077 .25 (15 minutes) ...................... 269 

211.180(e)—Production, control, and distribution records.4,360 .2 872 .25 (15 minutes) ...................... 218 

211.180(f)—Procedures for notification of regulatory actions.4,360 .2 872 1 .............................................. 872 

211.182—Equipment cleaning 

and use log.

4,360 2 8,720 .25 (15 minutes) ...................... 2,180 

211.184—Component, drug 

product container, closure, 

and labeling records.

4,360 3 13,080 .5 (30 minutes) ........................ 6,540 

211.186—Master production 

and control records.

4,360 10 43,600 2 .............................................. 87,200 

211.188—Batch production 

and control records.

4,360 25 109,000 2 .............................................. 218,000 

211.192—Discrepancies in 

drug product production and 

control records.

4,360 2 8,720 1 .............................................. 8,720 

211.194—Laboratory records .. 4,360 25 109,000 .5 (30 minutes) ........................ 54,500 

211.196—Distribution records 4,360 25 109,000 .25 (15 minutes) ...................... 27,250 

211.198—Compliant files ......... 4,360 5 21,800 1 .............................................. 21,800 

211.204—Returned drug products.4,360 10 43,600 .5 (30 minutes) ........................ 21,800 


asabaliauskas on DSK5VPTVN1PROD with NOTICES
Federal Register / Vol. 80, No. 37 / Wednesday, February 25, 2015 / Notices 10121 

TABLE 1—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1—Continued 

21 CFR Section Number of 

recordkeepers 

Number of records 

per recordkeeper 

Total annual 

records 

Average burden per 

recordkeeping Total hours 

Total .................................. ............................ .............................. ............................ .................................................. 882,203 

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

Dated: February 19, 2015. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2015–03881 Filed 2–24–15; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2013–N–0878] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Premarket 

Notification for a New Dietary 

Ingredient 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA or we) 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 

(the PRA). 

DATES: Fax written comments on the 

collection of information by March 27, 

2015. 

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 0910–0330. Also 

include the FDA docket number found 

in brackets in the heading of this 

document. 

FOR FURTHER INFORMATION CONTACT: FDA 

PRA Staff, Office of Operations, Food 

and Drug Administration, 8455 

Colesville Rd., COLE—14526, Silver 

Spring, MD 20993–0002, 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. 

Premarket Notification for a New 

Dietary Ingredient—21 CFR 190.6 

(OMB Control Number 0910–0330)— 

Extension 

Section 413(a) of the Federal Food, 

Drug, and Cosmetic Act (the FD&C Act) 

(21 U.S.C. 350b(a)) provides that at least 

75 days before the introduction or 

delivery for introduction into interstate 

commerce of a dietary supplement that 

contains a new dietary ingredient, the 

manufacturer or distributor of the 

dietary supplement or of the new 

dietary ingredient is to submit to us (as 

delegate for the Secretary of Health and 

Human Services) information upon 

which the manufacturer or distributor 

has based its conclusion that a dietary 

supplement containing the new dietary 

ingredient will reasonably be expected 

to be safe. FDA’s implementing 

regulation, 21 CFR 190.6, requires this 

information to be submitted to the 

Office of Nutrition, Labeling, and 

Dietary Supplements (ONLDS) in the 

form of a notification. Under § 190.6(b), 

the notification must include the 

following: (1) The name and complete 

address of the manufacturer or 

distributor, (2) the name of the new 

dietary ingredient, (3) a description of 

the dietary supplement(s) that contain 

the new dietary ingredient, including 

the level of the new dietary ingredient 

in the dietary supplement and the 

dietary supplement’s conditions of use, 

(4) the history of use or other evidence 

of safety establishing that the new 

dietary ingredient will reasonably be 

expected to be safe when used under the 

conditions recommended or suggested 

in the labeling of the dietary 

supplement, and (5) the signature of a 

responsible person designated by the 

manufacturer or distributor. 

These premarket notification 

requirements are designed to enable us 

to monitor the introduction into the 

marketplace of new dietary ingredients 

and dietary supplements that contain 

new dietary ingredients, in order to 

protect consumers from ingredients and 

products whose safety is unknown. We 

use the information collected in new 

dietary ingredient notifications to 

evaluate the safety of new dietary 

ingredients in dietary supplements and 

to support regulatory action against 

ingredients and products that are 

potentially unsafe. 

We are developing an electronic 

portal that interested persons will be 

able to use to electronically submit their 

notifications to ONLDS via FDA Unified 

Registration and Listing System 

(FURLS). Firms that prefer to submit a 

paper notification in a format of their 

own choosing will still have the option 

to do so, however. Form FDA 3880 

prompts a submitter to input the 

elements of a new dietary ingredient 

notification (NDIN) in a standard format 

and helps the submitter organize its 

NDIN to focus on the information 

needed for our safety review. Safety 

information will be submitted via a 

supplemental form entitled ‘‘New 

Dietary Ingredient (NDI) Safety 

Information.’’ This form provides a 

standard format to describe the history 

of use or other evidence of safety on 

which the manufacturer or distributor 

bases its conclusion that the new dietary 

ingredient will be reasonably expected 

to be safe under the conditions of use 

recommended or suggested in the 

labeling of the dietary supplement, as 

well as related identity information that 

is necessary to demonstrate safety by 

showing that the new dietary ingredient 

and dietary supplement(s) that are the 

subject of the notification are the same 

or similar to the ingredients and 

products for which safety data and 

information have been provided. Draft 

screenshots of Form FDA 3880 and the 

supplemental safety information form 

are available for comment at http://

www.fda.gov/Food/Dietary

Supplements/NewDietaryIngredients

NotificationProcess/ucm356620.htm. 

Description of Respondents: The 

respondents to this collection of 

information are manufacturers and 

distributors in the dietary supplement 

industry; specifically, firms that 

manufacture or distribute new dietary 

ingredients or dietary supplements that 

contain a new dietary ingredient. 

In the Federal Register of November 

14, 2014 (79 FR 68275), we published a 

60-day notice requesting public 

comment on the proposed extension of 

this collection of information. We 

received three comments in response to 

the notice. Two of the comments were 

unrelated to the PRA, and therefore we 

did not consider them. 


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