All Other Rubber Product Manufacturing (NAICS 326299) — A U.S. Industry Primer

1. Overview

"All Other Rubber Product Manufacturing" is the catch-all bucket of the U.S. rubber industry — the plants that turn natural and synthetic rubber into finished goods that don't fit the big named categories (tires, hoses, belts, and precision machine parts). Under the North American Industry Classification System (NAICS), the government-standard code for grouping businesses, this is code 326299.[1] Its products are everywhere but rarely branded: the single-ply rubber membrane on the flat roof of a warehouse, the rubber floor in a hospital or gym, the latex foam in a mattress, medical and industrial rubber tubing, rubber floor mats, rubber bands and balloons, roller coverings for printing presses and steel mills, and even reclaimed "crumb rubber" ground up from scrap tires.[1][2]

Why an investor cares: this is a small but sticky slice of the built environment and consumer-durables supply chain. It is not a growth story — it is a steady, replacement-driven, mostly-domestic manufacturing niche where the money is made on volume, input-cost management, and product specification rather than on rapid expansion.

Ways in differ sharply by product. There is no pure-play public company in NAICS 326299. Public-market investors get exposure only in slices, through large diversified building-products firms (roofing membrane, commercial flooring). Private investors get the more direct route: the industry is highly fragmented — roughly 531 firms[3] — with hundreds of small, family-owned molders, extruders, and recyclers that are classic lower-middle-market acquisition targets.

2. What it is and how it's structured

Scope. NAICS 326299 covers establishments that make rubber products from natural rubber (tapped from the Hevea tree) and synthetic rubber (petroleum-derived polymers such as EPDM — ethylene propylene diene monomer — and SBR — styrene-butadiene rubber), except the products carved out into their own codes.[1] The Census Bureau's illustrative examples include latex foam rubber, rubber balloons, rubber floor mats, rubber bands, rubber tubing, single-ply rubber (EPDM) roofing membrane, industrial and printing-press roll coverings, birth-control devices, and reclaiming rubber from scrap.[1][2] Rubber tubing is explicitly pulled into this code regardless of how it's made.[1]

What it excludes (and the adjacent codes). This is a residual category, so the exclusions matter:

• Tires and inner tubes, and tire retreading → NAICS 32621 (Tire Manufacturing).[1]
• Rubber hoses and belting → NAICS 326220 (Rubber and Plastics Hoses and Belting Manufacturing).[1]
• Molded, extruded, and lathe-cut rubber goods for mechanical use — gaskets, seals, O-rings, vibration mounts (i.e., most rubber auto and machinery parts) → NAICS 326291 (Rubber Product Manufacturing for Mechanical Use).[1]
• Rubber gloves → NAICS 339113 (Surgical Appliance and Supplies Manufacturing).[2]
• Heavy-duty inflatable rubber boats → NAICS 336612 (Boat Building).[1]

So 326299 is genuinely the "everything else" of rubber. Its single largest economic segment is EPDM roofing membrane; other meaningful clusters are rubber flooring, latex foam, specialty tubing, roll coverings, and recycled/crumb rubber.

How it's made. A typical producer purchases natural rubber, synthetic elastomers, or latex and combines them with fillers, process oils, pigments, antioxidants, accelerators, and curing agents. Operations can include internal mixing or milling, extrusion, calendering, dipping, or molding, followed by vulcanization (heat-curing), trimming, washing, inspection, and packaging.[21] Which steps matter depends on the product: latex tubing and prophylactics are commonly dipped or extruded; mats and flooring are molded or calendered; rubber bands begin as extruded tubing that is cured and cut. Non-tire rubber products use a much wider set of specialty elastomers than tire makers.[21]

Ownership mix. The base is a long tail of small independent and family-owned manufacturers, plus a handful of large brands that sit inside diversified public parents or private-equity platforms. The federal data show low concentration overall (see below), but individual sub-segments — roofing membrane especially — are effectively oligopolies dominated by a few national brands.

3. How big it is

Federal statistics give a clean, if narrow, picture. The figures below are U.S. Census Bureau and Small Business Administration (SBA) data.

That works out to roughly $23 million in shipments per firm on average and an average wage of about $62,900 per worker.[3][4] These are solidly middle-class manufacturing jobs, not minimum-wage assembly.

Concentration. The industry is fragmented. The four largest firms account for just 24.6% of revenue, the top eight for 37.3%, the top 20 for 51.3%, and the top 50 for 70.1%.[6] The Herfindahl-Hirschman Index (HHI, a standard 0–10,000 concentration gauge; U.S. antitrust regulators treat anything under 1,500 as unconcentrated) is only about 229 — very low.[6] Read that carefully, though: the low overall number reflects the diversity of unrelated products bundled into this code. Within the roofing-membrane and rubber-flooring niches, a few brands dominate.

Undercount caveat. Two things to keep in mind. First, this code deliberately excludes tires, hoses/belting, and mechanical rubber parts, so the ~$12.3 billion here is not "the U.S. rubber industry" — it is one residual slice of a much larger rubber economy split across several NAICS codes.[1][3] Second, the biggest branded products (EPDM roofing, premium rubber flooring) are made by large multi-line companies whose rubber output is only one plant or division; federal establishment counts capture the qualifying plants but the corporate parents' scale is far bigger than this table implies. Unlike some industries, 326299 is not meaningfully undercounted by being dominated by government or by tiny informal operators — it is a real, well-measured factory sector.

4. The investable universe

There is no listed pure play. Public exposure is partial and comes through diversified building-products companies; the most direct ownership is private.

Public companies with meaningful 326299 exposure (each is a partial exposure, not a pure play):

Major private and other owners:

• Elevate / Firestone Building Products — now inside Amrize (public via AMRZ).[8]
• GAF / Standard Industries — privately held roofing giant (mostly asphalt and TPO, some membrane systems).
• Talalay Global (formerly Latex International) — privately held; the only North American commercial producer of Talalay latex foam for bedding.[11]
• Kent Elastomer Products — privately held (owned by Meridian Industries); supplies medical, laboratory, food-and-beverage, and industrial markets with natural-latex, thermoplastic, and PVC tubing; describes itself as the only remaining U.S. producer of dipped natural-rubber-latex tubing.[23]
• Ecore International, Mondo, Roppe, Flexco, RC Musson, Tarkett/Johnsonite — mostly private rubber-flooring makers.[12]
• M+A Matting — privately held producer of entrance, anti-fatigue, and specialty mats; its SBR mat compound contains 20% recycled rubber.[24]
• Liberty Tire Recycling — North America's largest scrap-tire recycler and a leading crumb-rubber producer (~500 million pounds a year); acquired by infrastructure investor I Squared Capital from Energy Capital Partners in October 2025.[13]

For most investors the practical takeaway: to own "rubber products" in the public market you are really buying a roofing or flooring company that happens to run rubber lines. Direct, concentrated exposure lives in private hands.

5. How the money works

This is a materials-conversion manufacturing business, so the economics run on the classic manufacturing levers: volume, price, capacity utilization, and the spread between selling price and raw-material plus energy cost.

• Input costs are the swing factor. The main raw materials are natural rubber and synthetic rubbers (EPDM, SBR, nitrile), plus carbon black, fillers, and curing chemicals. These are volatile commodities. Synthetic-rubber prices in the U.S. drifted down to about $2,335 per metric ton by December 2025 on soft demand, while natural-rubber prices rose 14–15% across late 2025 into early 2026.[14][15] Feedstock spikes hit hard: Asian spot butadiene (a key SBR input) jumped about 67% in 2024–2025 on plant outages, squeezing margins for makers who couldn't pass the cost through.[14] A 2025 trade-association survey found that more than 51% of rubber processors had experienced raw-material cost increases of 5%–14%.[25] A structural bright spot: EPDM is made from ethylene and propylene, and cheap North American shale-derived feedstock gives U.S. EPDM producers a durable cost edge.[14]

• Natural-rubber import dependence. The United States relies entirely on imports for natural rubber. USDA reports that the country imported almost $1.5 billion of it in 2023; Indonesia supplied 47%, Thailand 27%, and Côte d'Ivoire 11%.[26] Tires consume more than 70% of natural rubber, meaning tire demand can set the marginal raw-material price even though tires are outside 326299.[26] Natural-rubber supply is exposed to weather, tree disease, plantation labor, shipping, and policy in a concentrated group of producing countries. Synthetic-rubber costs instead move with butadiene, styrene, acrylonitrile, and other petrochemical chains.

• Volume and capacity utilization. Because so much of the product is heavy, bulky, and freight-sensitive (roofing membrane, flooring, foam), plants make money by running full and shipping regionally. Underused capacity in a downturn is the main margin killer.

• Product mix determines pricing power. Commodity items (rubber bands, generic mats, crumb rubber) compete on cost and are exposed to imports. Specification-driven products — code-rated roofing membrane, low-emission healthcare flooring, medical tubing — carry brand premiums, thicker margins, and pull-through from architects and building codes. In custom tubing and dipped products, formulation knowledge, tooling, validation, traceability, and the cost of customer requalification can be more important than manufacturing scale.

• Replacement demand is the profit anchor. For the largest segment, EPDM roofing, most revenue is re-roofing of existing low-slope commercial buildings on a multi-decade replacement cycle — non-discretionary spending that is far steadier than new construction.[16] Similarly, crumb-rubber economics rest on a steady, non-cyclical feedstock: tires get scrapped every year regardless of the business cycle.[13]

6. What drives demand

• Non-residential construction and the re-roofing cycle — the biggest single driver, through EPDM membrane. Growth is tied to the installed base of flat commercial/industrial roofs and their replacement cadence, plus energy codes favoring durable "cool" roofs.[16]
• Commercial and institutional renovation — rubber flooring demand comes from hospitals, schools, transit, and fitness/recreation, where durability, slip resistance, and low maintenance win specs.[12]
• Consumer durables and bedding — latex foam tracks mattress and furniture demand.[11]
• Automotive, industrial, and print — specialty tubing and roll coverings follow factory output and capital spending.
• Medical, laboratory, and biopharma — specialty tubing and dipped products serve these markets, which can be relatively defensive compared to industrial cycles.[23]
• Sustainability and recycling mandates — recycled-content requirements, scrap-tire diversion programs, and green-building standards pull demand for crumb rubber and recycled-rubber flooring.[13][17]
• Infrastructure and sport — synthetic turf fields and playground surfacing consume large volumes of rubber infill (rubber is used in more than 80% of U.S. synthetic turf fields).[13]

7. Regulation

Rubber manufacturing carries a notably heavy regulatory and legacy-liability profile for an "old economy" sector.

• Occupational health. The International Agency for Research on Cancer (IARC) classifies "occupational exposures in the rubber-manufacturing industry" as a Group 1 carcinogen — carcinogenic to humans — based on historically elevated bladder, lung, and other cancers among rubber workers, tied to aromatic amines used before the 1950s–60s.[18] Modern controls have sharply reduced that risk (elevated rates largely disappear for workers first employed after 1960), but the classification keeps the sector under Occupational Safety and Health Administration (OSHA) scrutiny for chemical exposure, dust, and curing fumes.[18] OSHA has also identified potential exposure to N-nitroso compounds across mixing, milling, extrusion, curing, and molding jobs in rubber plants.[27] The Bureau of Labor Statistics reported a 2024 total recordable injury-and-illness incidence rate of 2.4 cases per 100 full-time workers for NAICS 326299, including 1.4 cases involving days away, restriction, or transfer.[28]
• Chemical rules. The Environmental Protection Agency (EPA) regulates rubber-compounding chemicals under the Toxic Substances Control Act (TSCA), with ongoing risk evaluations that can reach from labeling to outright bans; carbon black, nitrosamines, and certain processing additives are recurring concerns.[19] Air permits for volatile organic compounds and hazardous-waste handling add compliance cost.
• Wastewater and air emissions. EPA's industrial wastewater framework includes Rubber Manufacturing under 40 CFR Part 428, while air permits can address particulate, VOC, and hazardous-air-pollutant emissions from mixing, solvents, and curing.[29][21]
• Crumb-rubber scrutiny. Recycled tire rubber used as artificial-turf and playground infill faces public-health concern over chemical exposure, prompting EPA/CDC studies and procurement restrictions in some municipalities — a real demand risk for that end market.[13]
• Building and product codes. Roofing membrane must meet fire, wind-uplift, and energy-code requirements (FM/UL ratings, cool-roof standards), which shape product demand; flooring must meet emissions and slip standards.[16] Natural-latex condoms are Class II medical devices subject to FDA special controls under 21 CFR 884.5300; medical and food-contact tubing can bring additional quality-system, biocompatibility, and customer-audit requirements.[30] Product-liability severity is therefore far higher for a contraceptive or medical-fluid component than for a floor mat.

8. Competitive dynamics and consolidation

Two layers coexist. Overall the industry is fragmented and low-concentration (top four firms ~25% of revenue).[6] But the high-value niches are consolidated and consolidating:

• Roofing membrane is an oligopoly. A handful of brands — Carlisle SynTec, Elevate/Firestone (now Amrize), Johns Manville (Berkshire), Versico, GAF, and Sika — dominate U.S. single-ply, and industry estimates put the top few global single-ply makers at over 40% of that market combined (a market that also includes plastic TPO/PVC membranes).[16][7]
• Deal activity is steady. Holcim built Elevate by acquiring Firestone Building Products in 2021, then spun the whole North American business off as Amrize in 2025.[8] Interface bought nora to enter rubber flooring. Crumb-rubber leader Liberty Tire changed private-equity hands (Energy Capital Partners to I Squared Capital) in 2025.[13]
• The long tail is a roll-up hunting ground. With 500-plus firms, the small-molder, tubing, and regional-flooring base is exactly the kind of fragmented manufacturing where private-equity platforms and search funds assemble scale.[3]
• Import competition pressures commodity products (generic mats, bands, crumb rubber) from lower-cost Asian producers, while spec-driven, freight-heavy, code-rated products stay largely domestic.[20]

9. Risks

• Construction cyclicality. Despite the defensive re-roofing base, new-construction and renovation swings still move volumes and pricing.[16]
• Raw-material and energy volatility. Butadiene, natural-rubber, and ethylene/propylene price swings can compress margins fast when they can't be passed through.[14][15] Small producers may lack purchasing scale or rapid contractual pass-through.
• Natural-rubber supply concentration. Three countries (Indonesia, Thailand, Côte d'Ivoire) supply 85% of U.S. natural-rubber imports, exposing buyers to weather, disease, and policy risk in a narrow supplier base; some natural-rubber applications have few adequate synthetic substitutes.[26]
• Regulatory and liability drag. The IARC carcinogen legacy, TSCA chemical reviews, OSHA N-nitroso scrutiny, and crumb-rubber turf litigation/procurement bans all raise cost and can shrink specific end markets.[18][19][27][13]
• Substitution. Plastic TPO membrane has been taking share from EPDM in roofing; polyurethane foam competes with latex foam; thermoplastic elastomers, silicone, PVC, and other materials can replace conventional rubber where recycling, cleanliness, weight, or processability matters.[16] Conversely, rubber retains advantages in resilience, grip, fatigue resistance, and wide-temperature flexibility.
• Commoditization and imports in the low-spec segments.[20]
• Small-firm fragility. Much of the base is thinly capitalized family manufacturers exposed to succession risk, single-customer concentration, and capital-intensity of aging plants.
• Labor risk. Skilled compounders, extrusion and curing operators, maintenance technicians, and quality personnel can be hard to find; rubber processing also involves heat, presses, dusts, fumes, and chemicals that raise safety and retention challenges.[28]

10. How to invest, and the outlook

Public routes (all partial). There is no pure play, so exposure is a portfolio decision about which end market you want:

• Roofing-weighted: Carlisle Companies (CSL) and Amrize (AMRZ) are the cleanest large-cap EPDM-membrane exposures, though both also sell plastic membranes and other building products.[7][8]
• Flooring-weighted: Interface (TILE) for premium rubber flooring via nora (mostly a carpet-tile company).[9]
• Incidental: Sika (SIKA) and Berkshire Hathaway (BRK.B) carry membrane exposure inside much larger businesses.[10] Because rubber is a minority of each, expect these names to trade on their broader construction and building-products cycles, not on rubber fundamentals per se.

Private routes (more direct). The concentrated exposure is in private hands: private-equity platforms such as Liberty Tire (crumb rubber, I Squared Capital) and Ecore (recycled flooring); founder-owned specialists like Talalay Global (latex foam) and Kent Elastomer (medical/industrial tubing); and the wide field of regional tubing, mat, roll-covering, and molding shops that suit direct acquisition or roll-up strategies.[13][11][23][3]

Diligence considerations. Because NAICS is assigned at the establishment level while public-company reporting is consolidated differently, screening by company-level NAICS or by "non-tire rubber" revenue can generate false comparables. Diligence should be done product by product: formulation ownership, customer qualification and concentration, price-pass-through clauses, raw-material mix, scrap rate, plant utilization, deferred maintenance, environmental permits, worker exposure, import competition, and the cost for a customer to switch.

Near-term drivers and outlook (forward-looking). The base case is steady, low-single-digit growth rather than a boom. Supportive forces: the non-discretionary commercial re-roofing replacement cycle, tightening energy and cool-roof codes, growing recycled-content and scrap-tire-diversion mandates, domestic sourcing for qualified medical and industrial products, and a structural EPDM cost advantage from cheap North American shale feedstock.[16][14][17] The main headwinds are construction cyclicality, raw-material price swings, plastic-membrane substitution, and regulatory pressure on crumb-rubber end uses.[16][18][13] For public investors this is a cyclical building-products play accessed indirectly; for private investors it is a fragmented, cash-generative manufacturing base with room to consolidate — the more interesting opportunity set of the two.

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Sources

1. U.S. Census Bureau, "2022 NAICS Definition — 326299 All Other Rubber Product Manufacturing" (2022). https://www.census.gov/naics/ (via NAICS Association, https://www.naics.com/naics-code-description/?code=326299)
2. NAICS Association, "NAICS Code 326299 — product examples and exclusions (rubber gloves → 339113)" (2022). https://www.naics.com/naics-code-description/?code=32629
3. U.S. Census Bureau, "2022 Economic Census — Industry Statistics / Concentration, NAICS 326299 (firms 531; receipts $12.32 billion)" (2022). https://www.census.gov/programs-surveys/economic-census.html
4. U.S. Census Bureau, "County Business Patterns 2023 — NAICS 326299 (establishments 650; employment 32,409; annual payroll $2.04 billion)" (2023). https://www.census.gov/programs-surveys/cbp.html
5. U.S. Small Business Administration, "Table of Small Business Size Standards — NAICS 326299 (650 employees)" (2023). https://www.sba.gov/document/support-table-size-standards
6. U.S. Census Bureau, "2022 Economic Census — Concentration Ratios, NAICS 326299 (CR4 24.6%, CR8 37.3%, CR20 51.3%, CR50 70.1%, HHI 229.3)" (2022). https://www.census.gov/programs-surveys/economic-census.html
7. Carlisle Companies Inc., "Form 10-K, Fiscal Year 2024 (Carlisle Construction Materials ~$3.7 billion revenue; SynTec EPDM/TPO membranes)" (2025). https://www.sec.gov/Archives/edgar/data/790051/000079005125000077/csl-20241231.htm
8. Amrize Ltd. / Holcim, "Planned North American spin-off named Amrize; NYSE/SIX debut June 23, 2025 (~$30 billion; Elevate/Firestone Building Products)" (2025). https://investors.amrize.com/news/detail/100/holcims-north-america-business-to-be-named-amrize-following-planned-spin-off
9. Interface, Inc., "Form 10-K, Fiscal Year 2024 (total revenue ~$1.32 billion; nora rubber flooring)" (2025). https://www.sec.gov/Archives/edgar/data/715787/000071578725000006/tile-20241229.htm
10. Mordor Intelligence, "Single-Ply Membrane Market — Size & Share Analysis (Carlisle SynTec, Firestone, Johns Manville, Sika shares)" (2026). https://www.mordorintelligence.com/industry-reports/single-ply-membranes-market
11. Talalay Global, "About Us — U.S. Talalay latex foam manufacturer (formerly Latex International)" (2025). https://www.talalayglobal.com/about-us
12. ARCAT, "Manufacturers of Rubber Flooring (Ecore, Flexco, nora/Interface, Roppe, RC Musson, Mondo)" (2025). https://www.arcat.com/manufacturers/rubber_flooring
13. Grand View Research, "U.S. Recycled Tire Rubber Market Report; Liberty Tire Recycling acquired by I Squared Capital (Oct 2025); crumb-rubber turf/regulatory notes" (2025). https://www.grandviewresearch.com/industry-analysis/us-recycled-tire-rubber-market-report
14. ChemAnalyst, "Synthetic Rubber Prices, Trend & Forecast (U.S. ~$2,335/MT Dec 2025; butadiene +67%; EPDM shale feedstock advantage)" (2026). https://www.chemanalyst.com/Industry-data/synthetic-rubber-4
15. IMARC Group, "Natural Rubber Price Index 2026 — Trends and Forecast (late-2025/early-2026 gains)" (2026). https://www.imarcgroup.com/natural-rubber-pricing-report
16. IndexBox, "Single-Ply Roofing Membranes Market Forecast — commercial re-roofing demand, energy codes, EPDM vs TPO" (2025). https://www.indexbox.io/blog/single-ply-roofing-membranes-market-forecast-points-higher-toward-2035-on-commercial-reroofing-demand/
17. American Recycler, "Rubber recycling market expands (recycled-content demand, scrap-tire diversion)" (2025). https://americanrecycler.com/rubber-recycling-market-expands/
18. International Agency for Research on Cancer (IARC/WHO), "Occupational Exposures in the Rubber-Manufacturing Industry — Group 1 carcinogen; bladder/lung cancer history" (IARC Monographs, NCBI Bookshelf). https://www.ncbi.nlm.nih.gov/books/NBK304412/
19. U.S. Environmental Protection Agency, "Chemicals under TSCA — risk evaluation and management" (2025). https://www.epa.gov/chemicals-under-tsca
20. Federal Reserve Bank of Minneapolis, "Old jobs, new jobs: the labor landscape two decades after trade with China opened (manufacturing import exposure)" (2025). https://www.minneapolisfed.org/article/2025/old-jobs-new-jobs-how-the-labor-landscape-has-changed-two-decades-after-trade-with-china-opened
21. U.S. Environmental Protection Agency, "AP-42 Rubber Products Manufacturing — emissions and processing documentation" (2025). https://nepis.epa.gov/Exe/ZyPURL.cgi?Dockey=P100RGEV.TXT
22. Myers Industries, Inc., "Form 10-K, Fiscal Year 2025 (Patch Rubber, Distribution segment $203.9 million; announced intent to sell Myers Tire Supply)" (2026). https://www.sec.gov/Archives/edgar/data/69488/000119312526092521/mye-20251231.htm
23. Kent Elastomer Products, "About Us — U.S. medical/industrial tubing manufacturer (dipped latex, thermoplastic, PVC; owned by Meridian Industries)" (2025). https://www.kentelastomer.com/about-us/
24. M+A Matting, "Commercial Catalog — entrance, anti-fatigue, specialty mats (SBR compound 20% recycled rubber)" (2025). https://www.mamatting.com/documents/MA%20Commercial%20Catalog%20-%20Publish.pdf
25. Association for Rubber Products Manufacturers (ARPM), "Inside Rubber, Issue 3, 2025 (survey: >51% of processors experienced 5–14% raw-material cost increases)" (2025). https://publications.bigredm.com/flipbook/ARPM/2025/Issue3/
26. U.S. Department of Agriculture, Southwest Climate Hub, "Potential for Guayule Commercial Rubber Production (U.S. natural-rubber imports ~$1.5 billion 2023; Indonesia 47%, Thailand 27%, Côte d'Ivoire 11%; tires >70% of consumption)" (2025). https://www.climatehubs.usda.gov/hubs/southwest/topic/potential-guayule-commercial-rubber-production-southwest
27. U.S. Occupational Safety and Health Administration (OSHA), "Hazard Information Bulletin — N-nitroso compounds in rubber manufacturing" (1990, current guidance). https://www.osha.gov/publications/hib19900315
28. U.S. Bureau of Labor Statistics, "Table 1: Incidence rates of nonfatal occupational injuries and illnesses by industry — NAICS 326299 (2.4 TRC, 1.4 DART per 100 FTW, 2024)" (2025). https://www.bls.gov/web/osh/table-1-industry-rates-national.htm
29. U.S. Environmental Protection Agency, "Industrial Effluent Guidelines — Rubber Manufacturing (40 CFR Part 428)" (2025). https://www.epa.gov/eg/industrial-effluent-guidelines
30. U.S. Food and Drug Administration, "Male Condoms Made From Natural Rubber Latex — Small Entity Compliance Guide (Class II, 21 CFR 884.5300)" (2024). https://www.fda.gov/medical-devices/guidance-documents-medical-devices-and-radiation-emitting-products/male-condoms-made-natural-rubber-latex-21-cfr-8845300-small-entity-compliance-guide-designation