80 FR 37635 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; General Licensing Provisions; Section 351(k) Biosimilar Applications
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 80, Issue 126 (July 1, 2015)
Food and Drug Administration
Federal Register Volume 80, Issue 126 (July 1, 2015)
| Page Range | 37635-37637 | |
| FR Document | 2015-16128 |
[Federal Register Volume 80, Number 126 (Wednesday, July 1, 2015)] [Notices] [Pages 37635-37637] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-16128] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-0129] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; General Licensing Provisions; Section 351(k) Biosimilar Applications 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 July 31, 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 0910-0719. 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. General Licensing Provisions; Section 351(k) Biosimilar Applications OMB Control Number 0910-0719--Extension The Patient Protection and Affordable Care Act (Affordable Care Act) (Pub. L. 111-148) contains a subtitle called the Biologics Price Competition and Innovation Act of 2009 (BPCI Act), which amends the Public Health Service Act (PHS Act) and establishes an abbreviated licensure pathway for biological products shown to be biosimilar to, or interchangeable with, an FDA-licensed biological reference product (See sections 7001 through 7003 of the Affordable Care Act.) Section 351(k) of the PHS Act (42 U.S.C. 262(k)), added by the BPCI Act, sets forth the requirements for an application for a proposed biosimilar product and an application or a supplement for a proposed interchangeable product. Section 351(k) defines biosimilarity to mean ``that the biological product is highly similar to the reference product notwithstanding minor differences in clinically inactive components'' and that ``there are no clinically meaningful differences between the biological product and the reference product in terms of the safety, purity, and potency of the product.'' (See section 351(i)(2) of the PHS Act.) A 351(k) application must contain, among other things, information demonstrating that the biological product is biosimilar to a reference product based upon data derived from analytical studies, animal studies, and clinical studies, unless FDA determines, in its discretion, that certain studies are unnecessary in a 351(k) application. (See section 351(k)(2) of the PHS Act.) To demonstrate interchangeability, an applicant must provide sufficient information to demonstrate biosimilarity and that the biosimilar biological product can be expected to produce the same clinical result as the reference product in any given patient and, if the biosimilar biological product is administered more than once to an individual, the risk in terms of safety or diminished efficacy of alternating or switching between the use of the biosimilar biological product and the reference product is not greater than the risk of using the reference product without such alternation or switch. (See section 351(k)(4) of the PHS Act.) Interchangeable products may be substituted for the reference product without the intervention of the prescribing health care provider. (See section 351(i)(3) of the PHS Act.) In estimating the information collection burden for 351(k) applications, we reviewed the number of 351(k) applications FDA has received through fiscal year (FY) 2014, as well as the collection of information regarding the general licensing provisions for biologics license applications under section 351(a) of the PHS Act submitted to OMB (approved under OMB control number 0910-0338). For the information collection burden for 351(a) applications, FDA described Sec. 601.2(a) (21 CFR 601.2(a)) as requiring a manufacturer of a biological product to submit an application on forms prescribed for such purpose with accompanying data and information including certain labeling information to FDA for approval to market a product in interstate commerce. FDA also added in the burden estimate the container and package labeling requirements provided under Sec. Sec. 610.60 through 610.65 (21 CFR 610.60 through 610.65). The estimated hours per response for Sec. 601.2, and Sec. Sec. 610.60 through 610.65, are 860 hours. In addition, in submitting a 351(a) application, an applicant completes the Form FDA 356h, ``Application to Market a New Drug, Biologic, or an Antibiotic Drug for Human Use.'' The application form serves primarily as a checklist for firms to gather and submit certain information to FDA. The checklist helps to ensure that the application is complete and contains all the necessary information so that delays due to lack of information may be eliminated. The form provides key information to FDA for efficient handling and distribution to the appropriate staff for review. The estimated burden hours for biological product submissions using FDA Form 356h are included under the applicable requirements approved under OMB control number 0910-0338. To submit an application seeking licensure of a proposed biosimilar product under section 351(k)(2)(A)(i) and (k)(2)(A)(iii) of the PHS Act, FDA believes that the estimated burden hours would be approximately the same as noted under OMB control number 0910-0338 for a 351(a) application--860 hours. The burden estimates for seeking licensure of a proposed biosimilar product that meets the standards for interchangeability under section 351(k)(2)(B) and (k)(4) would also be 860 hours. Until we gain more experience with biosimilar applications, FDA believes this estimate is [[Page 37636]] appropriate for 351(k) applications because to determine biosimilarity or interchangeability of a proposed 351(k) product, the application and the information submitted is expected to be comparably as complex and technically demanding as a proposed 351(a) application. FDA may determine, in its discretion, an element required under a 351(k) application to be unnecessary to support licensure of a biosimilar or interchangeable product. In those cases, the number of hours per response may be less than the hours estimated. A summary of the information collection requirements in the submission of a 351(k) application as described under the BPCI Act follows: Section 351(k)(2)(A)(i) requires manufactures of 351(k) products to submit an application for FDA review and licensure before marketing a biosimilar product. An application submitted under this section shall include information demonstrating that:The biological product is biosimilar to a reference product based upon data derived from analytical studies, animal studies (including toxicity), and a clinical study or studies (including immunogenicity and pharmacokinetics or pharmacodynamics). The Secretary of Health and Human Services (the Secretary) may determine that any of these elements is unnecessary; The biological product and reference product utilize the same mechanism or mechanisms of action for the condition or conditions of use prescribed, recommended, or suggested in the proposed labeling, but only to the extent the mechanism or mechanisms of action are known for the reference product; The condition or conditions of use prescribed, recommended, or suggested in the labeling proposed for the biological product have been previously approved for the reference product; The route of administration, the dosage form, and the strength of the biological product are the same as those of the reference product; and The facility in which the biological product is manufactured, processed, packed, or held meets standards designed to assure that the biological product continues to be safe, pure, and potent. Section 351(k)(2)(A)(iii) requires the application to include publicly available information regarding the Secretary's previous determination that the reference product is safe, pure, and potent. The application may include any additional information in support of the application, including publicly available information with respect to the reference product or another biological product. Under section 351(k)(2)(B) and (k)(4), a manufacturer may include information demonstrating that the biological product meets the standards for interchangeability either in the application to show biosimilarity or in a supplement to such an application. The information submitted to meet the standard for interchangeability must show that: (1) The biological product is biosimilar to the reference product and can be expected to produce the same clinical result as the reference product in any given patient; and (2) for a biological product that is administered more than once to an individual, the risk in terms of safety or diminished efficacy of alternating or switching between use of the biological product and the reference product is not greater than the risk of using the reference product without such alternation or switch. In addition to the collection of information regarding the submission of a 351(k) application for a proposed biosimilar or interchangeable biological product, section 351(l) of the BPCI Act establishes procedures for identifying and resolving patent disputes involving applications submitted under section 351(k) of the PHS Act. The burden estimates for the patent provisions under section 351(l)(6)(C) of the BPCI Act are included in table 1 of this document and are based on the estimated number of 351(k) biosimilar respondents. Based on similar reporting requirements, FDA estimates this notification will take 2 hours. A summary of the collection of information requirements under section 351(l)(6)(C) follows: Not later than 30 days after a complaint from the reference product sponsor is served to a 351(k) applicant in an action for patent infringement described under 351(l)(6), section 351(l)(6)(C) requires that the 351(k) applicant provide the Secretary with notice and a copy of such complaint. The Secretary shall publish in the Federal Register notice any complaint received under section 351(l)(6)(C)(i). In the Federal Register of February 3, 2015 (80 FR 5761), FDA published a 60-day notice requesting public comment on the proposed collection of information. FDA received three comments. (Comment) One comment requested FDA provide clarity and interpretation regarding the standards for interchangeability (sections 351(k)(2)(B) and (k)(4) of the PHS Act). The comment also sought clarification regarding the timelines and the chosen mode of communication for FDA to convey to the stakeholders any details on an unnecessary element under a 351(k) application. (Response) FDA expects to issue a draft guidance, ``Considerations in Demonstrating Interchangeability to a Reference Product,'' in 2015. FDA issued a draft guidance, ``Formal Meetings Between the FDA and Biosimilar Biological Product Sponsors or Applicants,'' in 2013, which provides recommendations to industry on formal meetings between FDA and biosimilar biological product sponsors or applicants. (Comment) Another comment requested FDA provide clarity on the factors for consideration in assessing whether a proposed biosimilar is highly similar to a reference product to support a demonstration of biosimilarity--specifically, which product quality attributes are considered critical to match (and how much difference is allowed). (Response) FDA issued the final guidance, ``Quality Considerations in Demonstrating Biosimilarity of a Therapeutic Protein Product to a Reference Product,'' in April 2015. This final guidance provides further clarification on factors for consideration in assessing whether products are highly similar, including expression system, manufacturing process, impurities, reference product, and reference standards. (Comment) A third comment supported approval and post-market policies that would allow healthcare practitioners to make informative decisions when treating patients. (Response) FDA issued the final guidance, ``Scientific Considerations in Demonstrating Biosimilarity to a Reference Product,'' in April 2015. This guidance discusses a stepwise approach to demonstrating biosimilarity, the totality-of-the-evidence approach that FDA will use to review applications for biosimilar products, as well as general scientific principles in conducting comparative structural and functional analyses, animal testing, and clinical studies (including human pharmacokinetic and pharmacodynamic studies, clinical immunogenicity assessment, and comparative clinical studies). The guidance also provides information on postmarketing safety monitoring considerations. The comment also requested FDA consider adding as part of a biosimilar or interchangeable product's labeling instruction guidance on third party substitution of biosimilars without the knowledge of the healthcare provider. As noted by the comment, these issues [[Page 37637]] are also subject to state laws and regulations. Under the BPCI Act, a biological product that has been approved as an ``interchangeable'' may be substituted for the reference product without the intervention of the health care provider who prescribed the reference product. Based on the number of 351(k) applications FDA received through FY 2014, we estimate that we will receive approximately five 351(k) applications annually. The number of respondents submitting 351(k) applications is based on the number of sponsors submitting 351(k) applications through FY 2014. In making these estimates, FDA has taken into account, among other things, the expiration dates of patents that relate to potential reference products and general market interest in biological products that could be candidates for 351(k) applications. FDA estimates the burden of this collection of information as follows: Table 1--Estimated Annual Reporting Burden \1\ ---------------------------------------------------------------------------------------------------------------- Number of 351(k) Applications (42 U.S.C. Number of responses per Total annual Average burden Total hours 262(k)) respondents respondent responses per response ---------------------------------------------------------------------------------------------------------------- 351(k)(2)(A)(i) and 5 1 5 860 4,300 351(k)(2)(A)(iii) Biosimilar Product Applications........... 351(k)(2)(B) and (k)(4) 2 1 2 860 1,720 Interchangeable Product Applications or Supplements.... 351(l)(6)(C) Patent Infringement 5 1 5 2 10 Notifications.................. ------------------------------------------------------------------------------- Total....................... .............. .............. .............. .............. 6,030 ---------------------------------------------------------------------------------------------------------------- \1\ There are no capital costs or operating and maintenance costs associated with this collection of information. Dated: June 25, 2015. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2015-16128 Filed 6-30-15; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 80, No. 126 / Wednesday, July 1, 2015 / Notices 37635
approved under OMB control number Colesville Rd., COLE–14526, Silver section 351(k)(4) of the PHS Act.)
0910–0120. Spring, MD 20993–0002, PRAStaff@ Interchangeable products may be
fda.hhs.gov. substituted for the reference product
VI. Comments
SUPPLEMENTARY INFORMATION: In without the intervention of the
Interested persons may submit either prescribing health care provider. (See
electronic comments regarding this compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed section 351(i)(3) of the PHS Act.)
document to http://www.regulations.gov In estimating the information
or written comments to the Division of collection of information to OMB for
collection burden for 351(k)
Dockets Management (see ADDRESSES). It review and clearance.
applications, we reviewed the number
is only necessary to send one set of General Licensing Provisions; Section of 351(k) applications FDA has received
comments. Identify comments with the 351(k) Biosimilar Applications OMB through fiscal year (FY) 2014, as well as
docket number found in brackets in the Control Number 0910–0719—Extension the collection of information regarding
heading of this document. Received the general licensing provisions for
The Patient Protection and Affordable
comments may be seen in the Division biologics license applications under
Care Act (Affordable Care Act) (Pub. L.
of Dockets Management between 9 a.m. section 351(a) of the PHS Act submitted
111–148) contains a subtitle called the
and 4 p.m., Monday through Friday, and to OMB (approved under OMB control
Biologics Price Competition and
will be posted to the docket at http:// number 0910–0338). For the
Innovation Act of 2009 (BPCI Act),
www.regulations.gov. information collection burden for 351(a)
which amends the Public Health Service
Dated: June 26, 2015. applications, FDA described § 601.2(a)
Act (PHS Act) and establishes an
Leslie Kux, (21 CFR 601.2(a)) as requiring a
abbreviated licensure pathway for
manufacturer of a biological product to
Associate Commissioner for Policy. biological products shown to be
submit an application on forms
[FR Doc. 2015–16150 Filed 6–30–15; 8:45 am] biosimilar to, or interchangeable with,
prescribed for such purpose with
BILLING CODE 4164–01–P an FDA-licensed biological reference
accompanying data and information
product (See sections 7001 through
including certain labeling information
7003 of the Affordable Care Act.) to FDA for approval to market a product
DEPARTMENT OF HEALTH AND Section 351(k) of the PHS Act (42
in interstate commerce. FDA also added
HUMAN SERVICES U.S.C. 262(k)), added by the BPCI Act,
in the burden estimate the container and
sets forth the requirements for an package labeling requirements provided
Food and Drug Administration application for a proposed biosimilar under §§ 610.60 through 610.65 (21 CFR
[Docket No. FDA–2012–N–0129] product and an application or a 610.60 through 610.65). The estimated
supplement for a proposed hours per response for § 601.2, and
Agency Information Collection interchangeable product. Section 351(k) §§ 610.60 through 610.65, are 860 hours.
Activities; Submission for Office of defines biosimilarity to mean ‘‘that the In addition, in submitting a 351(a)
Management and Budget Review; biological product is highly similar to application, an applicant completes the
Comment Request; General Licensing the reference product notwithstanding Form FDA 356h, ‘‘Application to Market
Provisions; Section 351(k) Biosimilar minor differences in clinically inactive a New Drug, Biologic, or an Antibiotic
Applications components’’ and that ‘‘there are no Drug for Human Use.’’ The application
clinically meaningful differences form serves primarily as a checklist for
AGENCY: Food and Drug Administration,
between the biological product and the firms to gather and submit certain
HHS.
reference product in terms of the safety, information to FDA. The checklist helps
ACTION: Notice. purity, and potency of the product.’’ to ensure that the application is
SUMMARY: The Food and Drug (See section 351(i)(2) of the PHS Act.) A complete and contains all the necessary
Administration (FDA) is announcing 351(k) application must contain, among information so that delays due to lack of
that a proposed collection of other things, information demonstrating information may be eliminated. The
information has been submitted to the that the biological product is biosimilar form provides key information to FDA
Office of Management and Budget to a reference product based upon data for efficient handling and distribution to
(OMB) for review and clearance under derived from analytical studies, animal the appropriate staff for review. The
the Paperwork Reduction Act of 1995. studies, and clinical studies, unless estimated burden hours for biological
DATES: Fax written comments on the FDA determines, in its discretion, that product submissions using FDA Form
collection of information by July 31, certain studies are unnecessary in a 356h are included under the applicable
2015. 351(k) application. (See section requirements approved under OMB
351(k)(2) of the PHS Act.) To control number 0910–0338.
ADDRESSES: To ensure that comments on demonstrate interchangeability, an To submit an application seeking
the information collection are received, applicant must provide sufficient licensure of a proposed biosimilar
OMB recommends that written information to demonstrate product under section 351(k)(2)(A)(i)
comments be faxed to the Office of biosimilarity and that the biosimilar and (k)(2)(A)(iii) of the PHS Act, FDA
Information and Regulatory Affairs, biological product can be expected to believes that the estimated burden hours
OMB, Attn: FDA Desk Officer, FAX: produce the same clinical result as the would be approximately the same as
202–395–7285, or emailed to oira_ reference product in any given patient noted under OMB control number
submission@omb.eop.gov. All and, if the biosimilar biological product 0910–0338 for a 351(a) application—860
comments should be identified with the is administered more than once to an hours. The burden estimates for seeking
OMB control number 0910–0719. Also
tkelley on DSK3SPTVN1PROD with NOTICES
individual, the risk in terms of safety or licensure of a proposed biosimilar
include the FDA docket number found diminished efficacy of alternating or product that meets the standards for
in brackets in the heading of this switching between the use of the interchangeability under section
document. biosimilar biological product and the 351(k)(2)(B) and (k)(4) would also be
FOR FURTHER INFORMATION CONTACT: FDA reference product is not greater than the 860 hours. Until we gain more
PRA Staff, Office of Operations, Food risk of using the reference product experience with biosimilar applications,
and Drug Administration, 8455 without such alternation or switch. (See FDA believes this estimate is
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![Federal Register / Vol. 80, No. 126 / Wednesday, July 1, 2015 / Notices 37637
are also subject to state laws and Based on the number of 351(k) into account, among other things, the
regulations. Under the BPCI Act, a applications FDA received through FY expiration dates of patents that relate to
biological product that has been 2014, we estimate that we will receive potential reference products and general
approved as an ‘‘interchangeable’’ may approximately five 351(k) applications market interest in biological products
be substituted for the reference product annually. The number of respondents that could be candidates for 351(k)
without the intervention of the health submitting 351(k) applications is based applications.
care provider who prescribed the on the number of sponsors submitting
FDA estimates the burden of this
reference product. 351(k) applications through FY 2014. In
making these estimates, FDA has taken collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of Average
Number of Total annual
351(k) Applications (42 U.S.C. 262(k)) responses per burden per Total hours
respondents responses
respondent response
351(k)(2)(A)(i) and 351(k)(2)(A)(iii) Biosimilar Product Ap-
plications ........................................................................... 5 1 5 860 4,300
351(k)(2)(B) and (k)(4) Interchangeable Product Applica-
tions or Supplements ....................................................... 2 1 2 860 1,720
351(l)(6)(C) Patent Infringement Notifications ..................... 5 1 5 2 10
Total .............................................................................. ........................ ........................ ........................ ........................ 6,030
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: June 25, 2015. Division of Policy and Shortage administered by the Centers for
Leslie Kux, Designation, Bureau of Health Medicare and Medicaid Services,
Associate Commissioner for Policy. Workforce, Health Resources and certain qualified providers in
[FR Doc. 2015–16128 Filed 6–30–15; 8:45 am] Services Administration, Mail Stop geographic area HPSAs are eligible for
BILLING CODE 4164–01–P
11SWH03, Parklawn Building, 5600 increased levels of Medicare
Fishers Lane, Rockville, Maryland reimbursement.
20857, (301) 594–5168.
Development of the Designation and
DEPARTMENT OF HEALTH AND SUPPLEMENTARY INFORMATION:
Withdrawal Lists
HUMAN SERVICES Background
Criteria for designating HPSAs were
Health Resources and Services Section 332 of the PHS Act, 42 U.S.C. published as final regulations (42 CFR
Administration 254e, provides that the Secretary of HHS part 5) in 1980. Criteria then were
shall designate HPSAs based on criteria
Lists of Designated Primary Medical defined for each of seven health
established by regulation. HPSAs are
Care, Mental Health, and Dental Health professional types (primary medical
defined in section 332 to include (1)
Professional Shortage Areas care, dental, psychiatric, vision care,
urban and rural geographic areas with
podiatric, pharmacy, and veterinary
shortages of health professionals, (2)
AGENCY: Health Resources and Services care). The criteria for correctional
population groups with such shortages,
Administration, HHS. facility HPSAs were revised and
and (3) facilities with such shortages.
ACTION: Notice. published on March 2, 1989 (54 FR
Section 332 further requires that the
8735). The criteria for psychiatric
Secretary annually publish a list of the
SUMMARY: This notice advises the public HPSAs were expanded to mental health
designated geographic areas, population
of the published lists of all geographic groups, and facilities. The lists of HPSAs on January 22, 1992 (57 FR
areas, population groups, and facilities HPSAs are to be reviewed at least 2473). Currently funded PHS Act
designated as primary medical care, annually and revised as necessary. programs use only the primary medical
mental health, and dental health HRSA’s Bureau of Health Workforce care, mental health, or dental HPSA
professional shortage areas (HPSAs) as (BHW) has the responsibility for designations.
of May 29, 2015, available on the Health designating and updating HPSAs. Individual requests for designation or
Resources and Services Administration Public or private nonprofit entities are withdrawal of a particular geographic
(HRSA) Web site at http:// eligible to apply for assignment of area, population group, or a facility as
www.hrsa.gov/shortage/. HPSAs are National Health Service Corps (NHSC) a HPSA are received and reviewed
designated or withdrawn by the personnel to provide primary care, continuously by BHW. The majority of
Secretary of Health and Human Services mental, or dental health services in or the requests come from the Primary Care
(HHS) under the authority of section to these HPSAs. NHSC health Offices (PCO) in the State Health
332 of the Public Health Service (PHS) professionals with a service obligation Departments, who have access to the on-
Act and 42 CFR part 5. may enter into service agreements to line application and review system.
FOR FURTHER INFORMATION CONTACT: serve only in federally designated Requests that come from other sources
tkelley on DSK3SPTVN1PROD with NOTICES
Requests for further information on the HPSAs. Entities with clinical training are referred to the PCOs for their review
HPSA designations listed on the HRSA sites located in HPSAs are eligible to and concurrence. In addition, interested
Web site and requests for additional receive priority for certain residency parties, including the Governor, the
designations, withdrawals, or training program grants administered by State Primary Care Association and state
reapplication for designations should be the BHW. Many other federal programs professional associations are notified of
submitted to Kae Brickerd, Ph.D., also utilize HPSA designations. For each request submitted for their
Director, Shortage Designation Branch, example, under authorities comments and recommendations.
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Document Created: 2015-12-15 13:19:56
Document Modified: 2015-12-15 13:19:56
| 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 July 31, 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 37635 |
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