80 FR 10117 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Current Good Manufacturing Practice Regulations for Finished Pharmaceuticals
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 80, Issue 37 (February 25, 2015)
Food and Drug Administration
Federal Register Volume 80, Issue 37 (February 25, 2015)
| Page Range | 10117-10121 | |
| FR Document | 2015-03881 |
[Federal Register Volume 80, Number 37 (Wednesday, February 25, 2015)] [Notices] [Pages 10117-10121] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-03881] ----------------------------------------------------------------------- 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 [email protected]. 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, [email protected]. 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. [[Page 10118]] 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 Sec. 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 (Sec. 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 (Sec. 211.180(b)). All part 211 records must be readily available for authorized inspections during the retention period (Sec. 211.180(c)), and such records may be retained either as original records or as true copies (Sec. 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 (Sec. 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 Sec. 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 Sec. Sec. 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 [[Page 10119]] 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 Sec. 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 Sec. 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 Sec. 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 [[Page 10120]] and 680) reference certain CGMP regulations in part 211: Sec. Sec. 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 Sec. Sec. 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\ -------------------------------------------------------------------------------------------------------------------------------------------------------- Number of Number of records Total annual Average burden per 21 CFR Section recordkeepers per recordkeeper records 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 4,360 2 8,720 1............................... 8,720 control records or other records. 211.68(a)--Automatic, mechanical, and 4,360 10 43,600 .5 (30 minutes)................. 21,800 electronic equipment. 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 4,360 .25 1,090 .10 (6 minutes)................. 109 containers or closures. 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 4,360 .2 872 .25 (15 minutes)................ 218 distribution records. 211.180(f)--Procedures for notification of 4,360 .2 872 1............................... 872 regulatory actions. 211.182--Equipment cleaning and use log...... 4,360 2 8,720 .25 (15 minutes)................ 2,180 211.184--Component, drug product container, 4,360 3 13,080 .5 (30 minutes)................. 6,540 closure, and labeling records. 211.186--Master production and control 4,360 10 43,600 2............................... 87,200 records. 211.188--Batch production and control records 4,360 25 109,000 2............................... 218,000 211.192--Discrepancies in drug product 4,360 2 8,720 1............................... 8,720 production and control records. 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 ---------------------------------------------------------------------------------------------------------- [[Page 10121]] Total.................................... ................ ................. ................ ................................ 882,203 -------------------------------------------------------------------------------------------------------------------------------------------------------- \1\ There 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
![Federal Register / Vol. 80, No. 37 / Wednesday, February 25, 2015 / Notices 10117
the Executive Order and subject to Executive Order 13563 also requires You may also access documents of the
review by the Office of Management and an agency ‘‘to use the best available Department published in the Federal
Budget (OMB). Section 3(f) of Executive techniques to quantify anticipated Register by using the article search
Order 12866 defines a ‘‘significant present and future benefits and costs as feature at: www.federalregister.gov.
regulatory action’’ as an action likely to accurately as possible.’’ The Office of Specifically, through the advanced
result in a rule that may— Information and Regulatory Affairs of search feature at this site, you can limit
(1) Have an annual effect on the OMB has emphasized that these your search to documents published by
economy of $100 million or more, or techniques may include ‘‘identifying the Department.
adversely affect a sector of the economy, changing future compliance costs that Dated: February 19, 2015.
productivity, competition, jobs, the might result from technological
Kathy Greenlee,
environment, public health or safety, or innovation or anticipated behavioral
changes.’’ Administrator.
State, local, or tribal governments or
We are issuing this proposed priority [FR Doc. 2015–03888 Filed 2–24–15; 8:45 am]
communities in a material way (also
referred to as an ‘‘economically only upon a reasoned determination BILLING CODE 4154–01–P
significant’’ rule); that its benefits would justify its costs.
(2) Create serious inconsistency or In choosing among alternative
regulatory approaches, we selected DEPARTMENT OF HEALTH AND
otherwise interfere with an action taken
those approaches that would maximize HUMAN SERVICES
or planned by another agency;
(3) Materially alter the budgetary net benefits. Based on the analysis that
follows, the Department believes that Food and Drug Administration
impacts of entitlement grants, user fees,
or loan programs or the rights and this proposed priority is consistent with
the principles in Executive Order 13563. [Docket No. FDA–2011–N–0362]
obligations of recipients thereof; or
(4) Raise novel legal or policy issues We also have determined that this
regulatory action would not unduly Agency Information Collection
arising out of legal mandates, the Activities; Submission for Office of
interfere with State, local, and tribal
President’s priorities, or the principles Management and Budget Review;
governments in the exercise of their
stated in the Executive Order. Comment Request; Current Good
governmental functions.
This proposed regulatory action is not In accordance with both Executive Manufacturing Practice Regulations for
a significant regulatory action subject to Orders, the Department has assessed the Finished Pharmaceuticals
review by OMB under section 3(f) of potential costs and benefits, both
Executive Order 12866. AGENCY: Food and Drug Administration,
quantitative and qualitative, of this
We have also reviewed this regulatory HHS.
regulatory action. The potential costs
action under Executive Order 13563, are those resulting from statutory ACTION: Notice.
which supplements and explicitly requirements and those we have
reaffirms the principles, structures, and SUMMARY: The Food and Drug
determined as necessary for
definitions governing regulatory review Administration (FDA) is announcing
administering the Department’s
established in Executive Order 12866. that a proposed collection of
programs and activities.
To the extent permitted by law, The benefits of the Disability and information has been submitted to the
Executive Order 13563 requires that an Rehabilitation Research Projects and Office of Management and Budget
agency— Centers Program have been well (OMB) for review and clearance under
(1) Propose or adopt regulations only established over the years. Projects the Paperwork Reduction Act of 1995.
upon a reasoned determination that similar to one envisioned by the DATES: Fax written comments on the
their benefits justify their costs proposed priority have been completed collection of information by March 27,
(recognizing that some benefits and successfully, and the proposed priority 2015.
costs are difficult to quantify); would generate new knowledge through ADDRESSES: To ensure that comments on
(2) Tailor its regulations to impose the research. The new DRRP would the information collection are received,
least burden on society, consistent with generate, disseminate, and promote the OMB recommends that written
obtaining regulatory objectives and use of new information that would comments be faxed to the Office of
taking into account—among other things improve accessibility of the built Information and Regulatory Affairs,
and to the extent practicable—the costs environment for individuals with OMB, Attn: FDA Desk Officer, FAX:
of cumulative regulations; disabilities. 202–395–7285, or emailed to oira_
(3) In choosing among alternative Intergovernmental Review: This submission@omb.eop.gov. All
regulatory approaches, select those program is not subject to Executive comments should be identified with the
approaches that maximize net benefits Order 12372. OMB control number 0910–0139. Also
(including potential economic, Electronic Access to This Document: include the FDA docket number found
environmental, public health and safety, The official version of this document is in brackets in the heading of this
and other advantages; distributive the document published in the Federal document.
impacts; and equity); Register. Free Internet access to the
(4) To the extent feasible, specify official edition of the Federal Register FOR FURTHER INFORMATION CONTACT: FDA
performance objectives, rather than the and the Code of Federal Regulations is PRA Staff, Office of Operations, Food
behavior or manner of compliance a available via the Federal Digital System and Drug Administration, 8455
asabaliauskas on DSK5VPTVN1PROD with NOTICES
regulated entity must adopt; and at: www.gpo.gov/fdsys. At this site you Colesville Rd., COLE–14526, Silver
(5) Identify and assess available can view this document, as well as all Spring, MD 20993–0002, PRAStaff@
alternatives to direct regulation, other documents of this Department fda.hhs.gov.
including economic incentives—such as published in the Federal Register, in SUPPLEMENTARY INFORMATION: In
user fees or marketable permits—to text or Adobe Portable Document compliance with 44 U.S.C. 3507, FDA
encourage the desired behavior, or Format (PDF). To use PDF you must has submitted the following proposed
provide information that enables the have Adobe Acrobat Reader, which is collection of information to OMB for
public to make choices. available free at the site. review and clearance.
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![Federal Register / Vol. 80, No. 37 / Wednesday, February 25, 2015 / Notices 10121
TABLE 1—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1—Continued
Number of Number of records Total annual Average burden per
21 CFR Section Total hours
recordkeepers per recordkeeper records recordkeeping
Total .................................. ............................ .............................. ............................ .................................................. 882,203
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: February 19, 2015. Premarket Notification for a New ingredients and products that are
Leslie Kux, Dietary Ingredient—21 CFR 190.6 potentially unsafe.
Associate Commissioner for Policy. (OMB Control Number 0910–0330)— We are developing an electronic
[FR Doc. 2015–03881 Filed 2–24–15; 8:45 am] Extension portal that interested persons will be
BILLING CODE 4164–01–P
able to use to electronically submit their
Section 413(a) of the Federal Food, notifications to ONLDS via FDA Unified
Drug, and Cosmetic Act (the FD&C Act) Registration and Listing System
DEPARTMENT OF HEALTH AND (21 U.S.C. 350b(a)) provides that at least (FURLS). Firms that prefer to submit a
HUMAN SERVICES 75 days before the introduction or paper notification in a format of their
delivery for introduction into interstate own choosing will still have the option
Food and Drug Administration commerce of a dietary supplement that to do so, however. Form FDA 3880
contains a new dietary ingredient, the prompts a submitter to input the
[Docket No. FDA–2013–N–0878]
manufacturer or distributor of the elements of a new dietary ingredient
Agency Information Collection dietary supplement or of the new notification (NDIN) in a standard format
Activities; Submission for Office of dietary ingredient is to submit to us (as and helps the submitter organize its
Management and Budget Review; delegate for the Secretary of Health and NDIN to focus on the information
Comment Request; Premarket Human Services) information upon needed for our safety review. Safety
Notification for a New Dietary which the manufacturer or distributor information will be submitted via a
Ingredient has based its conclusion that a dietary supplemental form entitled ‘‘New
supplement containing the new dietary Dietary Ingredient (NDI) Safety
AGENCY: Food and Drug Administration, ingredient will reasonably be expected Information.’’ This form provides a
HHS. to be safe. FDA’s implementing standard format to describe the history
ACTION: Notice. regulation, 21 CFR 190.6, requires this of use or other evidence of safety on
information to be submitted to the which the manufacturer or distributor
SUMMARY: The Food and Drug Office of Nutrition, Labeling, and bases its conclusion that the new dietary
Administration (FDA or we) is Dietary Supplements (ONLDS) in the ingredient will be reasonably expected
announcing that a proposed collection to be safe under the conditions of use
form of a notification. Under § 190.6(b),
of information has been submitted to the recommended or suggested in the
the notification must include the
Office of Management and Budget labeling of the dietary supplement, as
following: (1) The name and complete
(OMB) for review and clearance under well as related identity information that
address of the manufacturer or
the Paperwork Reduction Act of 1995 is necessary to demonstrate safety by
distributor, (2) the name of the new
(the PRA). showing that the new dietary ingredient
dietary ingredient, (3) a description of
DATES: Fax written comments on the
the dietary supplement(s) that contain and dietary supplement(s) that are the
collection of information by March 27, the new dietary ingredient, including subject of the notification are the same
2015. the level of the new dietary ingredient or similar to the ingredients and
ADDRESSES: To ensure that comments on in the dietary supplement and the products for which safety data and
the information collection are received, dietary supplement’s conditions of use, information have been provided. Draft
OMB recommends that written screenshots of Form FDA 3880 and the
(4) the history of use or other evidence
comments be faxed to the Office of supplemental safety information form
of safety establishing that the new
Information and Regulatory Affairs, are available for comment at http://
dietary ingredient will reasonably be
OMB, Attn: FDA Desk Officer, FAX: www.fda.gov/Food/Dietary
expected to be safe when used under the
202–395–7285, or emailed to oira_ Supplements/NewDietaryIngredients
conditions recommended or suggested
submission@omb.eop.gov. All NotificationProcess/ucm356620.htm.
in the labeling of the dietary Description of Respondents: The
comments should be identified with the supplement, and (5) the signature of a
OMB control number 0910–0330. Also respondents to this collection of
responsible person designated by the information are manufacturers and
include the FDA docket number found manufacturer or distributor.
in brackets in the heading of this distributors in the dietary supplement
document. These premarket notification industry; specifically, firms that
requirements are designed to enable us manufacture or distribute new dietary
FOR FURTHER INFORMATION CONTACT: FDA to monitor the introduction into the ingredients or dietary supplements that
PRA Staff, Office of Operations, Food marketplace of new dietary ingredients contain a new dietary ingredient.
and Drug Administration, 8455 and dietary supplements that contain In the Federal Register of November
asabaliauskas on DSK5VPTVN1PROD with NOTICES
Colesville Rd., COLE—14526, Silver new dietary ingredients, in order to 14, 2014 (79 FR 68275), we published a
Spring, MD 20993–0002, PRAStaff@ protect consumers from ingredients and 60-day notice requesting public
fda.hhs.gov. products whose safety is unknown. We comment on the proposed extension of
SUPPLEMENTARY INFORMATION: In use the information collected in new this collection of information. We
compliance with 44 U.S.C. 3507, FDA dietary ingredient notifications to received three comments in response to
has submitted the following proposed evaluate the safety of new dietary the notice. Two of the comments were
collection of information to OMB for ingredients in dietary supplements and unrelated to the PRA, and therefore we
review and clearance. to support regulatory action against did not consider them.
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Document Created: 2015-12-18 13:09:34
Document Modified: 2015-12-18 13:09:34
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice. | |
| Dates | Fax written comments on the collection of information by March 27, 2015. | |
| Contact | FDA PRA Staff, Office of Operations, Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver Spring, MD 20993-0002, [email protected] | |
| FR Citation | 80 FR 10117 |
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